Robot therapist hits the spot with athletes

If you see a physiotherapist or a Chinese physician for a sprained back, do not be surprised if your therapist turns out to be a robot.

Meet Emma, unveiled today by a start-up incubated by Nanyang Technological University (NTU Singapore), which has been treating Singapore’s national athletes, such as national basketballer and Mediacorp actor Chase Tan.

Short for Expert Manipulative Massage Automation, Emma is now treating patients at the Singapore Sports Hub, using acupoint therapy to relieve muscle strains and injuries.

Developed by AiTreat, a start-up company founded by NTU graduate Albert Zhang, Emma is undergoing user trials at Kin Teck Tong’s Sports Science and Chinese Medicine Clinic at the Kallang Wave Mall.

Mr Zhang, the creator of Emma, said his creation, a robotic arm with a 3D-printed massage tip that runs on proprietary software, can resolve some of the challenges faced by sports therapy clinics, such as a shortage of trained therapists and a need to deliver high quality therapy consistently.



“We have designed Emma as a clinically precise tool that can automatically carry out treatment for patients as prescribed by a physiotherapist or Chinese physician,” said Mr Zhang, who graduated in 2010 from NTU’s Double Degree programme in Biomedical Sciences and Chinese Medicine.

“This is probably the first such robot in the world developed specifically for use by Traditional Chinese Medicine (TCM) physicians and sports therapists. Our aim is not to replace the therapists who are skilled in sports massage and acupoint therapy, but to improve productivity by enabling one therapist to treat multiple patients with the help of our robots.”

Emma, which has a user-friendly interface and recommended guidelines for various sports injuries, was designed by Mr Zhang based on his experience as a licensed TCM physician in Singapore for the past five years.

The robot consists of a single, 6-axis robotic arm capable of highly articulated movements, a 3D-stereoscopic camera for vision, and a customised, fully rotatable 3D-printed massage tip. Several safety features which work in tandem with advanced pressure sensors are also in-built, to ensure the comfort and the safety of its patients.

Since patient trials started last week at Kin Teck Tong, Emma has treated 50 patients with different conditions, such as tennis elbows, stiff neck and shoulders, lower back pain, as well as muscle pulls.

Integrating advanced sports science and traditional Chinese medicine, Kin Teck Tong is a modern medical institution with a chain of clinics that offer sports injury rehabilitation and pain management.

Executive Director of Kin Teck Tong, Ms Coco Zhang, said the new physiotherapy robot has the potential to be a disruptive innovation, especially in the TCM and sports science industry.

“Like many developed countries, Singapore has the problem of an aging population. Over the next decade, more people are going to suffer from physical ailments such as arthritis and will be seeking treatment,” Ms Zhang said.

“However, as the younger generation prefer knowledge-based jobs rather than physically intensive jobs such as massage therapists, there will likely be a shortage of trained therapists in future. In our trials with the robot, the experience has been very good, as it can perform most treatments as well as our therapists.”

Since Kin Teck Tong is the exclusive TCM Partner of the Singapore Athletic Association and Basketball Association of Singapore, delivering high quality therapy is extremely important for the athletes’ recovery, Ms Zhang added.

Physiotherapy meets the Cloud

To ensure a consistent quality of therapy, Emma has sensors and diagnostic functions that will measure the progress of the patient and the exact stiffness of a particular muscle or tendon.

These detailed diagnostics are uploaded to the cloud where the progress of each patient can be analysed and generated into a performance report. For the first time in TCM treatment, patients can accurately measure their recovery progress using precise empirical data.

This is extremely valuable for athletes, as their injuries, treatment and recovery can now be measured and monitored by their physician and therapists. In addition, the treatment programmes can be adjusted according to the progress of the patients’ recovery.

AiTreat’s propriety cloud intelligence is supported by Microsoft, after Mr Zhang and his teammates won the Microsoft Developer Day Start-up Challenge earlier this year.

Incubated at NTUitive, NTU’s innovation and enterprise arm, the one-year-old start-up spent six months developing their first prototype after receiving a grant from SPRING Singapore’s Ace Start-up grant.

After the clinical trials are completed, AiTreat will focus on developing its second-generation robot that is more compact and mobile.

“What we have demonstrated, is the possibility of having a tireless clinical massage therapist that always delivers high quality treatment,” added Mr Zhang.

Chief Executive Officer of NTU Innovation and NTUitive Dr Lim Jui said disruptive innovations like Emma are what the university hopes to achieve by nurturing an entrepreneurial and innovative culture amongst NTU students, graduates and professors.

“We are happy to support one of NTU’s promising graduates to turn his dream into reality that will benefit society,” Dr Lim said. “We hope to encourage more of our students to follow Albert’s footsteps, daring to dream and willing to plunge into uncharted waters to develop future solutions to benefit Singapore and the world.”

Full story can be found from NTU website by following this link.

Pneumonia discovery may offer way to boost body's defenses

A molecule being targeted in cancer is also critical for the immune system’s ability to battle pneumonia, researchers at the School of Medicine have determined. The finding may offer a new way for doctors to boost patients’ ability to fight off the life-threatening infection as bacteria become more and more resistant to antibiotics.

“We’re interested in seeing if there are things we an do to strengthen the natural defenses of the host to help them fight the infection more effectively,” said Borna Mehrad, MBBS, of UVA’s Division of Pulmonary and Critical Care Medicine. “Potentially this would be the sort of thing you could do in addition to antibiotics to help patients with severe infections.”
Mysterious role

Mehrad and his team determined that the lack of the cytokine M-CSF (short for macrophage-colony stimulating factor) in infected mice worsened the outcome of bacterial pneumonia: Not having the protein resulted in 10 times more bacteria in the lungs, 1,000 times more bacteria in the blood and spread the infection to the liver, resulting in increased deaths.

Clearly M-CSF has an important role in battling pneumonia, but what exactly does it do? “M-CSF has previously been shown to help make a type of immune cell, called monocytes, so my idea was that if you take it away, infected hosts just stop making monocytes and that’s why they get sick,” Mehrad said, “and it turned out that was completely wrong.”

Instead, the researchers determined, M-CSF helped monocytes survive once they have arrived in the infected tissues. Mehrad credited a PhD student in his lab, Alexandra Bettina, with making key observations that completely changed the course of the research. “As I had expected, when we blocked the action of M-CSF … we saw fewer monocytes in the lung. And I thought, well, there you have it,” Mehrad said. “But what Alexandra did was look at the number of cells in the bone marrow, when they’re made, and the blood, which is how they get to the lung. And she found that, in the absence of M-CSF, the number of monocytes in the bone marrow and blood was completely unaffected … but was dramatically reduced in the lung.”

That meant the original hypothesis was wrong. The cells were being made despite the lack of the cytokine; they just weren’t surviving in the lungs to do their jobs. “To use an analogy, they are like soldiers mobilizing,” Mehrad said. “They’re being made in the right number, they’re arriving in the right number, but when they get there, they’re not very good soldiers.”

But by knowing more about M-CSF, doctors one day may be able to make them very good soldiers indeed. “If you take M-CSF away, the infections get worse, so that raises two important questions about therapy: Would more be better? It may be that during infection, the body is making the right amount of M-CSF and if we add extra, it won’t improve outcomes further,” he said. “The second possibility is that there is room for improvement: in the fight between monocytes and the bacteria, M-CSF may make monocytes live longer and give them an edge. In addition, some people with weakened immunity might not make enough of M-CSF. If that’s the case, you could augment that and improve their ability to fight the infection.”

More information can be found from University of Virginia website.

Boston Scientific Announces Acquisition of Cosman Medical

Boston Scientific Corporation announced that it has acquired Cosman Medical, Inc., a privately held Burlington, Mass. manufacturer of radiofrequency ablation (RFA) systems. The Cosman Medical team and products will become part of the Boston Scientific Neuromodulation business, which offers a range of Spinal Cord Stimulator (SCS) systems to treat patients with chronic pain, and Deep Brain Stimulation systems* for the treatment of Parkinson's disease, dystonia and essential tremor.

"This acquisition is a natural extension of our current product portfolio and will help us provide physicians and patients more options to address chronic pain with non-opioid therapeutic treatments," said Maulik Nanavaty, senior vice president and president, Neuromodulation, Boston Scientific. "The addition of the Cosman Medical product line, which is built on industry-leading technology and known for its high-quality, expands our capability to provide innovative solutions for the treatment of chronic pain."

One in three Americans suffer from chronic pain and more than 100 million people are partially or totally disabled by pain. In the United States, it is the number one cause of disability in adults.1,2 RFA is a versatile outpatient procedure with a more than 50-year track record of providing relief for patients with chronic pain. It works by applying heat to small areas of nerve tissue to interrupt pain signals. SCS works by sending electrical signals to the spinal cord, masking pain signals from reaching the brain. In the continuum of care for pain, RFA is typically used prior to SCS. While many patients with chronic pain find effective relief from RFA, others progress to SCS to manage pain.

"We are pleased to join the Boston Scientific team and help expand access to leading treatments for chronic pain," said Eric Cosman, Jr, PhD, scientific director, Cosman Medical. "This acquisition comes at a time when our society is recognizing the impact of relying extensively on opioids to treat pain and is looking for additional approaches. Our mutual commitment to innovation and quality will help us deliver solutions."

The expansion into RFA follows the recent Boston Scientific launch of the Precision Montage™ MRI Spinal Cord Stimulator (SCS) System which offers customized relief to patients with chronic pain while also enabling safe access to full body magnetic resonance imaging (MRI) in a 1.5 Tesla environment when conditions of use are met. MultiWave™ Technology enables delivery of multiple waveforms, including burst and higher rates, intended to help respond to changes in pain over time. The launch expanded the suite of Boston Scientific products that leverage the Illumina 3D™ algorithm, a three-dimensional, anatomy-driven computer model designed for simple point-and-click pain targeting to support physicians in treating chronic pain. In addition to the new Precision Montage MRI SCS System, the portfolio includes the Precision Spectra™ System, which is designed to provide broad coverage for pain with 32 contacts, and the Precision Novi™ System, the smallest high-capacity non-rechargeable device.

Boston Scientific currently expects the net impact of this transaction on adjusted earnings per share to be break-even in 2016 and accretive thereafter and more dilutive on a GAAP basis as a result of acquisition-related net charges and amortization. Specific terms of the transaction were not disclosed.

A press release can be found from Boston Scientific website.

Withings launches non-contact smart phone connected thermometer

Withings launched a new thermometer - Thermo. A fast, simple, non-contact gesture yields the most precise temperature possible, and automatic sync with the dedicated app also allows users to track temperature readings, get reminders, and input related symptoms/medications right on smartphone.

    

Thermo measures from the temporal artery, considered the best place to detect temperature changes, as the blood that circulates there comes from the core of the body. As Thermo sweeps across the forehead, 16 infrared sensors take over 4,000 measurements to find the hottest point. This is the revolutionary advance, and is what we call HotSpot Sensor™ Technology.

An exceedingly simple scan across the forehead requires no contact with the skin. Unlike traditional methods, Thermo avoids any contact with saliva, earwax or other body fluids — making it the most sanitary way to take anyone’s temperature.

Readings appear illuminated on the device along with a color-coded LED indicator to tell you if the temperature is normal, elevated or high based on the age of the user.

Measurements sync automatically with your smartphone. Based on age, fever history, and symptoms, the Thermo app gives advanced health advice. In addition to tracking temperature and symptoms, users can enter comments, medications, and even photos in any user profile. This helps users see if the treatment is effective and allows users to have a complete history to share with a doctor.

More information can be found from Withings website.

Scientists develop painless microneedle system to monitor drugs

Researchers at UBC and the Paul Scherrer Institut (PSI) in Switzerland have created a microneedle drug monitoring system that could one day replace costly, invasive blood draws and improve patient comfort.

The new system consists of a small, thin patch that is pressed against a patient’s arm during medical treatment and measures drugs in their bloodstream painlessly without drawing any blood. The tiny needle-like projection, less than half a milimetre long, resembles a hollow cone and doesn’t pierce the skin like a standard hypodermic needle.



“Many groups are researching microneedle technology for painless vaccines and drug delivery,” said researcher Sahan Ranamukhaarachchi, a PhD student and Vanier scholar in UBC’s faculties of applied science and pharmaceutical sciences, who developed this technology during a research exchange at PSI. “Using them to painlessly monitor drugs is a newer idea.”

Microneedles are designed to puncture the outer layer of skin, which acts as a protective shield, but not the next layers of epidermis and the dermis, which house nerves, blood vessels and active immune cells.

The microneedle created by Ranamukhaarachchi and his colleagues was developed to monitor the antibiotic vancomycin, which is used to treat serious infections and is administered through an intravenous line. Patients taking the antibiotic undergo three to four blood draws per day and need to be closely monitored because vancomycin can cause life-threatening toxic side effects.

The researchers discovered that they could use the fluid found just below the outer layer of skin, instead of blood, to monitor levels of vancomycin in the bloodstream. The microneedle collects just a tiny bit of this fluid, less than a millionth of a millilitre, and a reaction occurs on the inside of the microneedle that researchers can detect using an optical sensor. This technique allows researchers to quickly and easily determine the concentration of vancomycin.

“This is probably one of the smallest probe volumes ever recorded for a medically relevant analysis,” said Urs Hafeli, associate professor in UBC’s faculty of pharmaceutical sciences.

“The combination of knowhow from UBC and PSI, bringing together microneedles, microfluidics, optics and biotechnology, allowed us to create such a device capable of both collecting the fluid and performing the analysis in one device,” said Victor Cadarso, a research scientist and Ambizione Fellow at PSI.

More information can be found from University of British Columbia website.

Researchers invent “smart” thread that collects diagnostic data when sutured into tissue

For the first time, researchers led by Tufts University engineers have integrated nano-scale sensors, electronics and microfluidics into threads – ranging from simple cotton to sophisticated synthetics – that can be sutured through multiple layers of tissue to gather diagnostic data wirelessly in real time, according to a paper published online July 18 in Microsystems & Nanoengineering. The research suggests that the thread-based diagnostic platform could be an effective substrate for a new generation of implantable diagnostic devices and smart wearable systems.



The researchers used a variety of conductive threads that were dipped in physical and chemical sensing compounds and connected to wireless electronic circuitry to create a flexible platform that they sutured into tissue in rats as well as in vitro. The threads collected data on tissue health (e.g. pressure, stress, strain and temperature), pH and glucose levels that can be used to determine such things as how a wound is healing, whether infection is emerging, or whether the body’s chemistry is out of balance. The results were transmitted wirelessly to a cell phone and computer.

The three-dimensional platform is able to conform to complex structures such as organs, wounds or orthopedic implants.

While more study is needed in a number of areas, including investigation of long-term biocompatibility, researchers said initial results raise the possibility of optimizing patient-specific treatments.

“The ability to suture a thread-based diagnostic device intimately in a tissue or organ environment in three dimensions adds a unique feature that is not available with other flexible diagnostic platforms,” said Sameer Sonkusale, Ph.D., corresponding author on the paper and director of the interdisciplinary Nano Lab in the Department of Electrical and Computer Engineering at Tufts School of Engineering. “We think thread-based devices could potentially be used as smart sutures for surgical implants, smart bandages to monitor wound healing, or integrated with textile or fabric as personalized health monitors and point-of-care diagnostics.”

Until now, the structure of substrates for implantable devices has essentially been two-dimensional, limiting their usefulness to flat tissue such as skin, according to the paper. Additionally, the materials in those substrates are expensive and require specialized processing.

“By contrast, thread is abundant, inexpensive, thin and flexible, and can be easily manipulated into complex shapes,” said Pooria Mostafalu, Ph.D., first author on the paper who was a doctoral student at Tufts when he worked on the project and is now a postdoctoral research fellow with the Harvard-MIT Division of Health Sciences and Technology, Brigham and Women’s Hospital, and the Wyss Institute for Biologically Inspired Engineering at Harvard University. “Additionally, analytes can be delivered directly to tissue by using thread’s natural wicking properties.”

Full story can be found from Tufts University website by following this link.

New Superconducting Coil Improves MRI Performance

A multidisciplinary research team led by University of Houston scientist Jarek Wosik has developed a high-temperature superconducting coil that allows magnetic resonance imaging (MRI) scanners to produce higher resolution images or acquire images in a shorter time than when using conventional coils.

Wosik, a principal investigator at the Texas Center for Superconductivity at UH, said test results show the new technology can reveal brain structures that aren’t easily visualized with conventional MRI coils. He also is a research professor in the UH Department of Electrical and Computer Engineering.

The cryo-coil works by boosting the signal-to-noise ratio (SNR) – a measure of the strength of signals carrying useful information – by a factor of two to three, compared with conventional coils. SNR is critical to the successful implementation of high resolution and fast imaging.

Wosik said the cryo-coil reveals more details than a conventional coil because of its enhanced SNR profile. Where a conventional coil does not have enough sensitivity to “see,” a superconducting coil can still reveal details. These details will remain hidden to conventional coils even when image acquisition is repeated endlessly.

For the initial tests, the probe was optimized for rat brain imaging, useful for biomedical research involving neurological disorders. But it also has direct implications for human health care, Wosik said.

“Research in animal models yields critical information to improve diagnosis and treatment of human diseases and disorders,” he said. “This work also has the potential to clearly benefit clinical MRI, both through high quality imaging and through shortening the time patients are in the scanner.”

Results from preliminary testing of the 7 Tesla MRI Cryo-probe were presented at the International Symposium of Magnetic Resonance in Medicine annual meeting in May. The coil can be optimized for experiments on living animals or brain tissue samples, and researchers said they demonstrated an isotropic resolution of 34 micron in rat brain imaging. In addition to its use in MRI coils, superconductivity lies at the heart of MRI scanning systems, as most high-field magnets are based on superconducting wire.

In addition to Wosik, collaborators on the project include Ponnada A. Narayana, director of the Magnetic Resonance Imaging Center and a professor in the Department of Diagnostic and Interventional Imaging at the University of Texas Health Science Center at Houston; Kurt H. Bockhorst, senior research scientist at UT Houston; Kuang Qin, a graduate student working with Wosik; and I-Chih Tan, assistant professor in the Department of Neuroscience at Baylor College of Medicine.

Compared to corresponding standard room temperature MRI coils, the performance of the cooled normal metal and/or the high-temperature superconducting receiver coils lead either to an increase in imaging resolution and its quality, or to a very significant reduction in total scan time,” Wosik said.

More information can be found from University of Houston website by following this link.

Soberlink real-time mobile-breathalyzer FDA approved

Soberlink announced that the Soberlink Breathalyzer has received 510(k) premarket clearance from the U.S. Food and Drug Administration (FDA) for medical use by healthcare providers to remotely measure alcohol in human breath, for the purpose of aiding in the detection and monitoring of alcohol consumption in those who suffer from alcohol use disorders.

Soberlink and Sober Sky Web Portal act as an accountability tool that allows recovering individuals to conveniently and discreetly share blood alcohol content (BAC) results with their treatment providers and recovery circle from almost anywhere in the world. Soberlink has worked for over five years with the top treatment facilities and addiction experts to develop a protocol for using the Soberlink System in clinical monitoring of alcohol use disorders.



“It is great to see the FDA clearing a remote monitoring device for recovery management by healthcare providers. Remote clinical monitoring has been used successfully in the treatment of other chronic diseases such as diabetes and hypertension to monitor key disease progression indicators and has provided the kind of information that healthcare professionals can use to adjust and improve their patients’ care,” says Tom McLellan, Founder and Chairman of the Board of Directors at Treatment Research Institute. “It is about time that we have the same kind of technology to provide personalized, continuing care for alcohol use disorders.”

The longer a person stays involved with consistent monitoring, the better the long-term outcome. The traditional standard of care for alcohol monitoring has been urinalysis testing. With the Soberlink Cellular Device and Sober Sky Web Portal, testing is no longer confined to a laboratory environment. The flexibility of the Soberlink System and partnership with Verizon Wireless empowers individuals to test from nearly anywhere and at any time.

“According to studies from the Centers for Disease Control and Prevention, nearly 88,000 people die from alcohol-related causes annually, making alcohol the fourth leading preventable cause of death in the United States,” stated Brad Keays, Founder and CEO of Soberlink. “Further attesting to its prevalence, the Foundation for a Drug-Free World cites that out of the 3.9 million Americans who received treatment for any kind of substance abuse problem in 2005, 2.5 million of them were treated for alcohol use.

“Improved outcomes are the mandate in all of healthcare, and Soberlink is at the forefront of this movement,” Keays said. “Soberlink is working hard to advance technology to improve outcomes in addiction treatment. These advances encourage transparency and flexibility and reinforce trust between the patient and treatment provider. FDA clearance is a significant milestone for our company and paves the way toward continued growth in the healthcare space.”

A press release can be found from Soberlink website.

Cheap paper strips for cancer testing at home

Chemists at The Ohio State University are developing paper strips that detect diseases including cancer and malaria—for a cost of 50 cents per strip.

The idea, explained Abraham Badu-Tawiah, is that people could apply a drop of blood to the paper at home and mail it to a laboratory on a regular basis—and see a doctor only if the test comes out positive. The researchers found that the tests were accurate even a month after the blood sample was taken, proving they could work for people living in remote areas.



The assistant professor of chemistry and biochemistry at Ohio State conceived of the papers as a way to get cheap malaria diagnoses into the hands of people in rural Africa and southeast Asia, where the disease kills hundreds of thousands of people and infects hundreds of millions every year.

But in the Journal of the American Chemical Society, he and his colleagues report that the test can be tailored to detect any disease for which the human body produces antibodies, including ovarian cancer and cancer of the large intestine.

The patent-pending technology could bring disease diagnosis to people who need it most—those who don’t have regular access to a doctor or can’t afford regular in-person visits, Badu-Tawiah said.

“We want to empower people. If you care at all about your health and you have reason to worry about a condition, then you don’t want to wait until you get sick to go to the hospital. You could test yourself as often as you want,” he said.

The technology resembles today’s “lab on a chip” diagnostics, but instead of plastic, the “chip” is made from sheets of plain white paper stuck together with two-sided adhesive tape and run through a typical ink jet printer.

Instead of regular ink, however, the researchers use wax ink to trace the outline of channels and reservoirs on the paper. The wax penetrates the paper and forms a waterproof barrier to capture the blood sample and keep it between layers. One 8.5-by-11-inch sheet of paper can hold dozens of individual tests that can then be cut apart into strips, each a little larger than a postage stamp.

“To get tested, all a person would have to do is put a drop of blood on the paper strip, fold it in half, put it in an envelope and mail it,” Badu-Tawiah said.

The technology works differently than other paper-based medical diagnostics like home pregnancy tests, which are coated with enzymes or gold nanoparticles to make the paper change color. Instead, the paper contains small synthetic chemical probes that carry a positive charge. It’s these “ionic” probes that allow ultra-sensitive detection by a handheld mass spectrometer.

“Enzymes are picky. They have to be kept at just the right temperature and they can’t be stored dry or exposed to light,” Badu-Tawiah said. “But the ionic probes are hardy. They are not affected by light, temperature, humidity—even the heat in Africa can’t do anything to them. So you can mail one of these strips to a hospital and know that it will be readable when it gets there.”

The chemists designed ionic probes to tag specific antibodies that extract the disease biomarker from the blood and onto the paper chip. Once they are extracted, the chemicals stay unchanged until the paper is dipped in an ammonia solution at the laboratory. There, someone peels the paper layers apart and holds them in front of a mass spectrometer, which detects the presence of the probes based on their atomic characteristics—and, by extension, the presence of biomarkers in an infected person’s blood.

Badu-Tawiah and postdoctoral researchers Suming Chen and Qiongqiong Wan successfully demonstrated that they could detect protein biomarkers from the most common malaria parasite, Plasmodium falciparum, which is most prevalent in Africa.

They also successfully detected the protein biomarker for ovarian cancer, known as cancer antigen 125, and the carcinoembryonic antigen, which is a marker for cancer of the large intestine, among other cancers.

They worked with former doctoral student Yang Song in the lab of colleague Vicki Wysocki, professor of chemistry and biochemistry, to study how the probes stick to the antibodies with a high-resolution mass spectrometer. Wysocki is the Ohio Eminent Scholar of Macromolecular Structure and Function and director of the Campus Chemical Instrument Center at Ohio State.

After confirming that their tests worked, Badu-Tawiah and his team stored the strips away and re-tested them every few days to see if the signal detected by the mass spectrometer would fade over time. It didn’t. The signal was just as strong after 30 days as on day one, meaning that the disease proteins were stable and detectable even after a month.

Since the antibody strips survive more than long enough to reach a lab by mail, they could open up a whole new world of medical care for people in rural communities—even in the United States, Badu-Tawiah said. Even for people living in the city, testing themselves at home would save money compared to going to the doctor.

In the US, he said, the tests would be ideal for people who have a family history of cancer or have successfully undergone cancer treatment. Instead of waiting to visit a doctor every six months to confirm that they are still in remission, they could test themselves from home more frequently.

In the case of malaria, the human and financial costs are high, especially in Africa.

Malaria is a mosquito-borne disease caused by parasites. The infection starts with flulike symptoms that can develop into kidney failure or other complications. The Centers for Disease Control and Prevention estimates that there were 214 million cases of malaria worldwide in 2015, and 438,000 people died—mostly children in Africa.

“In Africa, malaria is so common that whenever you get feverish, the first thing you think is, ‘Oh, it’s probably malaria,’” Badu-Tawiah said.

While the prototype test strips at Ohio State cost about 50 cents each to produce, those costs would likely go down with mass production, he said. The greatest cost of using the strips would fall to urban medical facilities, which would have to purchase mass spectrometers to read the results. Model portable instruments can cost $100,000 but less expensive handheld mass specs are under development.

Still, Badu-Tawiah pointed out, an initial investment in mass specs would be more than offset by the potential boon to Africa’s economy. UNICEF estimates that malaria costs the continent $12 billion in lost worker productivity every year.

In the United States, where mass spectrometers are more common, the cost savings would come in the form of reduced insurance use and fewer out-of-pocket expenses from going to the doctor less often.

“Although this approach requires an initial investment, we believe the low-cost paper-based consumable devices will make it sustainable,” Badu-Tawiah said. “We can set one small instrument at a grocery store, then sell the paper strips for just 50 cents per test. The same for Africa, and perhaps much cheaper there.”

The university will license the technology to a medical diagnostics company for further development, and Badu-Tawiah hopes to be able to test the strips in a clinical setting within three years. In the meantime, he and his colleagues are working to make the tests more sensitive, so that people could eventually use them non-invasively, with saliva or urine as the test material instead of blood.

Full story can be found from The Ohio State University website.

CFDA issues the Decision on Amending Good Supply Practice for Pharmaceutical Products

In order to further strengthen the quality management of drug distribution, and ensure drug safety, the Decision on Amending Good Supply Practice for Pharmaceutical Products was adopted at the executive meeting of China Food and Drug Administration (CFDA) on June 30, 2016, and shall go into effect as of the date of promulgation. CFDA issued the newly amended Good Supply Practice for Pharmaceutical Products on July 20, 2016.

Medtronic Continuous Glucose Monitoring (CGM) System CE Approved

Medtronic announced it has received CE Mark for its new Guardian(TM) Connect mobile continuous glucose monitoring (CGM) system for people with diabetes using insulin injection therapy. Guardian Connect is the first smartphone-enabled CGM system from Medtronic to receive CE Mark and further demonstrates the company's intent to provide solutions for people across the diabetes care continuum. The system will be launched on a country-by-country basis in the second quarter of fiscal year 2017, beginning with select countries in Europe, Asia Pacific, and Latin America.


With Guardian Connect, people on insulin injections will be able to check their current glucose level anytime on their mobile device, as easily as checking other information sources such as email, the weather or social media. They can also be alerted of high and low glucose levels on their mobile device, helping them confidently avoid or address high and low glucose situations. Guardian Connect is the first and only mobile CGM system with customizable SMS text alerts enabling care partners to receive high and low glucose alerts on any connected mobile device. The system also features the option to automatically upload the data daily into CareLink(TM) therapy management software, which reduces the burden of data upload for both people on insulin injection therapy as well as their healthcare providers.

"Having continuous, real-time access to glucose values and being alerted to important trends and events is key for people with diabetes. With our new Guardian Connect system, we've continued to innovate so we can deliver these insights for people with diabetes on insulin injection therapy," said Annette Brüls, president, Diabetes Service and Solutions at Medtronic. "Guardian Connect is also compatible with our CareLink® diabetes therapy management platform and arms healthcare providers, their patients and care partners with actionable data to help improve day-to-day diabetes management and make long-term therapy adjustments. Expanding our solutions to help more people with diabetes no matter where they are on the care continuum is central to our goal of transforming diabetes care for greater freedom and better health."

The Guardian Connect system consists of a small wearable CGM device that takes glucose readings every five minutes (288 times a day) and sends these glucose values directly to a smartphone app. People on insulin injection therapy can use the system to check glucose levels on their mobile phones, enabling them to see highs and lows in real-time, understand the trends and help improve their daily management of diabetes. Alerts can also be set up if glucose levels go above or below preset levels, helping patients prevent or address potentially dangerous high and low glucose events. All of this information can be shared with care partners via SMS text messages and via access to the real-time CGM tracing from any web-enabled device. In addition, healthcare providers can leverage automatic daily data uploads via CareLink.

The Guardian Connect smartphone app will initially be available with iOS devices. Medtronic is currently developing an Android version of the Guardian Connect app for release at a later date. The Guardian Connect system is not yet available for sale in the United States.

A press release can be found from Medtronic website.

3D weaving technique to grow a living hip replacement

With a goal of treating worn, arthritic hips without extensive surgery to replace them, scientists have programmed stem cells to grow new cartilage on a 3-D template shaped like the ball of a hip joint. What’s more, using gene therapy, they have activated the new cartilage to release anti-inflammatory molecules to fend off a return of arthritis.

The technique, demonstrated in a collaborative effort between Washington University School of Medicine in St. Louis and Cytex Therapeutics Inc. in Durham, N.C., is described July 18 in Proceedings of the National Academy of Sciences.



The discovery one day may provide an alternative to hip-replacement surgery, particularly in younger patients. Doctors are reluctant to perform such operations in patients under age 50 because prosthetic joints typically last for less than 20 years. A second joint-replacement surgery to remove a worn prosthetic can destroy bone and put patients at risk for infection.

“Replacing a failed prosthetic joint is a difficult surgery,” said Farshid Guilak, PhD, a professor of orthopedic surgery at Washington University. “We’ve developed a way to resurface an arthritic joint using a patient’s own stem cells to grow new cartilage, combined with gene therapy to release anti-inflammatory molecules to keep arthritis at bay. Our hope is to prevent, or at least delay, a standard metal and plastic prosthetic joint replacement.”

The technique uses a 3-D, biodegradable synthetic scaffold that Guilak and his team developed. The scaffold, molded into the precise shape of a patient’s joint, is covered with cartilage made from the patient’s own stem cells taken from fat beneath the skin. The scaffold then can be implanted onto the surface of an arthritic hip, for example. Resurfacing the hip joint with “living” tissue is designed to ease arthritis pain, and delay or even eliminate the need for joint-replacement surgery in some patients.

Additionally, by inserting a gene into the newly grown cartilage and activating it with a drug, the gene can orchestrate the release of anti-inflammatory molecules to fight a return of arthritis, which usually is what triggers such joint problems in the first place.

“When there is inflammation, we can give a patient a simple drug, which activates the gene we’ve implanted, to lower inflammation in the joint,” said Guilak, also a professor of developmental biology and of biomedical engineering. “We can stop giving the drug at any time, which turns off the gene.”

The 3-D scaffold is built using a weaving pattern that gives the device the structure and properties of normal cartilage. Franklin Moutos, PhD, vice president of technology development at Cytex, explained that the unique structure is the result of approximately 600 biodegradable fiber bundles woven together to create a high-performance fabric that can function like normal cartilage.

“As evidence of this, the woven implants are strong enough to withstand loads up to 10 times a patient’s body weight, which is typically what our joints must bear when we exercise,” Moutos said.

Currently, there are about 30 million Americans who have diagnoses of osteoarthritis, and data suggest that the incidence of osteoarthritis is on the rise. That number includes many younger patients — ages 40 to 65 — who have limited treatment options because conservative approaches haven’t worked and they are not yet candidates for total joint replacement because of their ages.

Bradley Estes, PhD, vice president of research and development at Cytex, noted, “We envision in the future that this population of younger patients may be ideal candidates for this type of biological joint replacement.”

Guilak, who also is the director of research at Shriners Hospitals for Children — St. Louis, and co-director of the Washington University Center of Regenerative Medicine, has been collaborating with Cytex on this research. The scientists have tested various aspects of the tissue engineering in cell culture, and some customized implants already are being tested in laboratory animals. He said if all goes well, such devices could be ready for safety testing in humans in three to five years.

More information can be found from Washington University School of Medicine website.

An engineered protein can disrupt tumor-promoting ‘messages’ in human cells

Over a century of research has shined light on the once-murky innards of our cells, from the genes that serve as our “blueprints” to the proteins and other molecules that are our cellular taskmasters.

Building on this basic knowledge, the search is underway for cellular mechanisms that could serve as gateways for new therapies. These could lead to precise treatments for disease — targeting a specific cellular function or gene with fewer unintended side effects. Ideally, these effects would also be temporary, returning cells to normal operation once the underlying condition has been treated.



A team of researchers from the University of Washington and the University of Trento in Italy announced findings that could pave the way for these therapies. In a paper published July 18 in Nature Chemical Biology, they unveiled an engineered protein that they designed to repress a specific cancer-promoting message within cells.

And that approach to protein design could be modified to target other cellular messages and functions, said senior author and UW chemistry professor Gabriele Varani.

“What we show here is a proving ground — a process to determine how to make the correct changes to proteins,” he said.

For their approach, Varani and his team modified a human protein called Rbfox2, which occurs naturally in cells and binds to microRNAs. These aptly named small RNA molecules adjust gene expression levels in cells like a dimmer switch. Varani’s group sought to engineer Rbfox2 to bind itself to a specific microRNA called miR-21, which is present in high levels in many tumors, increases the expression of cancer-promoting genes and decreases cancer suppressors. If a protein like Rbfox2 could bind to miR-21, the researchers hypothesized, it could repress miR-21’s tumor growth effects.

But for this approach to be successful, the protein must bind to miR-21 and no other microRNA. Luckily, all RNA molecules, including microRNAs, have an inherent property that imbues them with specificity. They consist of a chain of chemical “letters,” each with a unique order or sequence. To date, no other research team had ever successfully altered a protein to bind to microRNAs.



“That is because our knowledge of protein structure is much better than our knowledge of RNA structure,” said Varani. “We historically lacked key information about how RNA folds up and how proteins bind RNA at the atomic level.”

UW researchers relied on high-quality data on Rbfox2’s structure to understand, down to single atoms, how it binds to the unique sequence of “letters” in its natural RNA targets. Then they predicted how Rbfox2’s sequence would have to change to make it bind to miR-21 instead. Elegantly, altering just four carefully selected amino acids made Rbfox2 shift its attachment preference to miR-21, preventing the microRNA from passing along its tumor-promoting message.

The UW team spent several years proving this, since they had to test each change individually and in combination. They also had to make sure that the modified Rbfox2 protein would bind strongly to miR-21 but not other microRNAs. Since microRNAs have many functions in cells, it would be counterproductive to repress miR-21 while disrupting other normal microRNA-mediated functions.

The researchers also engineered a second protein that should clear miR-21 from cells entirely. They did this by grafting the regions of Rbfox2 that bound to miR-21 onto a separate protein called Dicer. Dicer normally chops RNAs into small chunks and generates functional microRNAs. But the hybrid Rbfox2-Dicer protein displayed a specific affinity to slice miR-21 into oblivion.

Varani and his team believe that Rbfox2 could be redesigned to bind to microRNA targets other than miR-21. There are thousands of microRNAs to choose from, and many have been implicated in diseases. The key to realizing this potential would be in streamlining and automating the painstaking methods the team used to model Rbfox2’s atomic-level interactions with RNA.

“This method relies on knowledge of high-quality structures,” said Varani. “That allowed us to see which alterations would change binding to the microRNA target.”

Not only would these be useful laboratory tools to study microRNA functions, but they could — in time — form the basis of new therapies to treat disease.

Lead author on the paper is former UW researcher Yu Chen, who is now at the Seattle Children’s Research Institute. Other UW chemistry co-authors were Fang Yang, Tom Pavelitz, Wen Yang, Katherine Godin, Matthew Walker and Suxin Zheng. Co-authors from the University of Trento include Lorena Zubovic and Paolo Macchi. The research was funded by the National Institutes of Health, the University of Trento and the government of Trento province.

Full story can be found from University of Washington website.

Penumbra Launches Newest Stroke Thrombectomy Technology Device

Penumbra announced U.S. commercial availability of its most advanced thrombectomy device, the ACE™68 Reperfusion Catheter, part of the fully integrated Penumbra System®, at the Society of NeuroInterventional Surgery (SNIS) 13th Annual Meeting in Boston, Massachusetts.



The ACE68 Reperfusion Catheter leverages the latest advancements in tracking technology to deliver maximum aspiration power easily and safely for extracting thrombus in acute ischemic stroke patients.

Clinical experience with the ACE68 will be shared today from 1:30-1:45 p.m. ET in the Industry Technology Luncheon Symposium by Blaise Baxter, M.D., chief of radiology at Erlanger Hospital in Tennessee and chairman of radiology for the University of Tennessee College of Medicine Chattanooga.

“The tracking technology of the ACE68 Reperfusion Catheter is the most advanced,” said Baxter. “In my clinical experience with the ACE68, I saw the device easily navigate difficult tortuosity that would have challenged other devices. ACE68’s tracking performance, combined with a large aspiration lumen to enable efficient clot removal, make ACE68 the most compelling frontline device in stroke intervention.”

The ACE68 Reperfusion Catheter was engineered on a new, innovative tracking platform from hub to tip. Featuring a unique coil winding geometry along 16 transitions to create the optimal tracking profile, ACE68 is designed to ensure easy tracking through tortuosity that is typical in acute ischemic stroke patients. ACE68 is powered to extract clot en masse quickly and effectively as part of the fully integrated Penumbra System.

“With the ACE68 Reperfusion Catheter, I can easily deliver full aspiration power to the occlusion,” said Johanna Fifi, M.D., assistant professor of neurology, neurosurgery and radiology at The Mount Sinai Hospital and director of the Endovascular Stroke Program at the Mount Sinai Health System in New York. “The ACE68’s large lumen increases the likelihood of capturing the clot fully within the catheter or the canister, potentially reducing the number of passes to achieve complete revascularization and minimize ENT (embolization to new territory).”

“The ACE68 provides an opportunity to reverse strokes faster and with less expense,” said Adam Arthur, M.D., MPH, FACS, professor, Department of Neurosurgery, UTHSC, Semmes-Murphey Neurologic & Spine Institute. “The larger lumen seems to allow better clot capture, which may reduce the need for adjunctive devices, simplify the procedure and reduce procedure cost -- important considerations as hospitals look to expand stroke services.”

The ACE68 represents the latest advances in tracking technology to deliver a large bore reperfusion catheter easily and reliably through tortuosity that is typical in acute ischemic stroke patients.

“We designed the ACE68 with the intent to make real improvement on stroke procedure time, outcome and cost. The early reports from physicians on the performance of ACE68 confirm that this is the most impactful stroke product we have ever developed,” said Adam Elsesser, chairman and chief executive officer of Penumbra.

A press release can be found from Penumbra website.

Novocure Receives FDA Approval for Second Generation Optune System

Novocure announced that the U.S. Food and Drug Administration (FDA) approved its premarket approval (PMA) supplement application for Novocure’s second generation Optune system. The new smaller, lighter Tumor Treating Fields (TTFields) delivery system is now available to glioblastoma (GBM) patients in the United States.



Novocure designed the second generation Optune system to make treatment with TTFields more convenient and manageable for GBM patients. The new model features a TTFields generator that is less than half the weight and half the size of the generator in the first generation Optune system. Including its battery, the second generation Optune system weighs 2.7 pounds, compared to the first generation system that weighs 6 pounds. Novocure reduced the size and weight of Optune by utilizing novel digital signal generation technology. Additional improvements include: easy-grip texture that allows for better handling; a battery indicator that displays power and alerts patients when to change the battery; a light-detecting sensor that auto-dims the device and charger in the dark; and a “No-Stop Swap” feature that enables patients to change batteries or power source without disrupting delivery of TTFields therapy.

Novocure started offering the second generation Optune system to patients in Germany in October 2015 and has since made it available to all new patients in Europe.

“From the start, Novocure’s mission has been to improve the lives of cancer patients,” said Mike Ambrogi, Novocure’s Chief Operating Officer. “The second generation Optune system was designed to be more convenient and to make it even easier for patients to incorporate treatment with TTFields into their lives. We have received positive feedback from our second generation Optune patients in Europe, and we are excited to roll out our new device to patients in the United States.”

Novocure will offer existing Optune patients in the United States the opportunity to convert to the second generation Optune system over the next several weeks. All new patients will receive the second generation Optune system.

“We are happy to receive FDA approval of our second generation Optune system,” said Asaf Danziger, Novocure’s Chief Executive Officer. “We believe the improvements incorporated into the second generation Optune system will make a big difference to the patients and families who face this devastating disease every day. We will continue to work to improve our technology and patient experience.”

A press release can be found from Novocure website.

Chocolate Heart, a novel drug-coated coronary balloon, received CE approval

QT Vascular Ltd announced that it has received CE mark clearance for the sale and distribution of the Chocolate Heart™ drug-coated PTCA balloon for dilatation of the stenotic portion of coronary arteries for the purpose of improving myocardial perfusion in Europe.

      

Chocolate Heart™ is the drug-coated version of the Company’s Chocolate® PTCA balloon that has been commercially available in the United States (“US”) since late 2014. Chocolate® PTCA features a unique nitinol constraining structure that causes the balloon to open in a controlled uniform fashion, thus is designed to reduce acute trauma, dissections, and unplanned stenting compared to conventional balloons. Initial evidence of this has previously been demonstrated in a trial of the peripheral version of Chocolate® known as Chocolate® PTA (“Chocolate BAR”)1. The Company has added a proprietary coating containing the proven drug, paclitaxel, to the Chocolate® PTCA platform in order to reduce the incidence of repeat procedures. This combination of an atraumatic balloon platform and a proven therapeutic agent is intended to allow certain patients to be treated with Chocolate Heart™ while avoiding the need for a permanent implant such as a metallic stent.

Drug-coated balloons represent a rapidly growing new category of device that combines the mechanical dilatation of a balloon catheter with the biological effect of a drug to treat occluded arteries in the leg. These devices have been available for several years in Europe and were recently approved in the United States. Since their approval in the U.S., adoption has been increasing and CMS (Centers for Medicare and Medicaid Services) has granted additional reimbursement for these devices. According to some analyst estimates3, revenues for drug-coated peripheral balloons are expected to reach $1 billion by 2020. The Company believes that drugcoated balloons may also play an important role in the future in the treatment of patients with disease in their coronary arteries.

More information can be found from QT Vascular Ltd website.

Liver tissue model accurately replicates hepatocyte metabolism, response to toxins

A team of researchers from the Massachusetts General Hospital (MGH) Center for Engineering in Medicine (MGH-CEM) have created a “liver on a chip,” a model of liver tissue that replicates the metabolic variations found throughout the organ and more accurately reflects the distinctive patterns of liver damage caused by exposure to environmental toxins, including pharmaceutical overdose. Their report has been published online in the journal Scientific Reports.




"Our goal with this project was to create a liver tissue construct that responds to toxins the same way the liver in your body does," says William McCarty, PhD, a postdoctoral fellow at MGH-CEM and the paper's lead author. "The liver is a chemical processing plant, but it’s not a single vat; different locations within the liver react differently to drugs and toxins. Here, we exploited microfluidics to control the metabolism of liver cells down to a resolution of a few cells, allowing us to create liver tissue that shows the same patterns of toxicity caused by differences in drug metabolism as the liver in your body."

When blood passes through the liver, it travels from arteries to veins through channels called sinusoids, lined with the liver cells called hepatocytes. From one end of the sinusoid to another, the hepatocytes have different metabolic functions, often controlled by external factors and gene expression. For example, the cells closest to the arterial end of the sinusoid are most efficient at releasing glucose that has been stored in the form of glycogen, while cells at the venous end are most efficient at taking up and storing glucose. Similar differences for other liver functions are well known, with metabolic changes occurring across the 25-cell length of the sinusoid.

In order to develop a system that more closely replicates the metabolic differences among hepatocytes, the research team developed a microfluidic device that distributes hormones or other chemical agents across a 20- to 40-cell-wide sample of hepatocytes in such a way that the effects on the liver cells vary from one side to the other. For example, if blood-sugar-lowering insulin is fed into one of the device’s two inlets while glucagon, which raises blood sugar, is added through the other, the metabolism of the hepatocytes is changed so that those on one side release glucose while those on the other take it up. The use of other agents produced similar results across the field of hepatocytes regarding nitrogen metabolism or alcohol degradation, and use of a molecule that induces the expression of drug metabolism enzymes resulted in varied zones of susceptibility to the toxic effects of acetaminophen.

"Investigators have been developing in-vitro liver models for 40 years, but all of those systems ignore the distinct patterns of metabolically active hepatocytes that exist within the liver sinusoid" says Martin Yarmush, MD, PhD, director of the MGH-CEM and the paper's senior author. "We hope this tool, which displays zonation of carbohydrate and nitrogen metabolism, in addition to drug detoxification and alcohol degradation, will improve our ability to understand and predict the effects of toxins and new drugs on the liver."

More information can be found from Massachusetts General Hospital website.

FDA Approves Extended Depth of Focus Lenses for People with Cataracts

Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved the Tecnis Symfony® Intraocular Lenses for the treatment of cataracts. The first in a new category of intraocular lenses (IOLs), the Tecnis Symfony lenses are the only lenses in the United States that provide a full range of continuous high-quality vision following cataract surgery, while also mitigating the effects of presbyopia by helping people focus on near objects. The FDA approval includes a version of the lens for people with astigmatism, the Tecnis Symfony Toric IOL.



Cataracts are a common condition, with almost 4 million cataract surgeries performed each year, and that number is expected to increase.1 By age 80, more than half of all Americans either have a cataract or have had cataract surgery.2 However, cataracts do not just impact seniors. In 2016 it is estimated that nearly one in four cataract surgeries will be performed on people younger than 65.1 Many people who have cataracts experience other problems with their vision, such as presbyopia and astigmatism, which the Symfony lenses also address. Presbyopia, which affects most people over age 40, means people have lost the ability to focus on objects up close and often require glasses to perform near visual tasks. Astigmatism is when the cornea is misshapen, which causes blurry or distorted vision.

"The Symfony intraocular lens is a new option I can offer my patients to improve their vision following cataract surgery, especially those who have difficulty focusing on objects at near distances because of presbyopia," said Eric D. Donnenfeld, M.D., of Ophthalmic Consultants of Long Island, New York. "Many of my patients live very active lifestyles and want to see clearly at all distances, and without glasses if possible. With the Symfony lens, I can give patients the freedom to enjoy the activities that matter to them, while wearing glasses less."

During cataract surgery, the natural lens of the eye is removed, and an artificial lens, called an intraocular lens, or IOL, is inserted into the eye. The IOL most commonly used in cataract surgery is a monofocal lens, which only allows the person to see at a distance, with closer objects being out of focus. In contrast, the Symfony lens was specifically developed with features to improve both the range and quality of vision.

"Abbott is focused on improving people's vision and their lives by helping them stay healthy and active. Symfony offers patients, including those with astigmatism, an option for crisp, clear vision at all distances," said Thomas Frinzi, senior vice president of Abbott's vision business. "This is an important addition to our portfolio of lenses, as we expect many patients to choose a Symfony lens over a standard monofocal lens, given its benefits. We are happy that we can offer more people around the world this new category of lenses."

The approval was based on results of a U.S. pivotal study that compared the Tecnis Symfony lens to a Tecnis aspheric monofocal lens in 298 patients. Compared with patients in the monofocal group, those who received a Tecnis Symfony IOL achieved greater improvements in intermediate and near vision while maintaining similar distance vision. Patients in the Symfony group were also more likely to achieve reduced overall spectacle wear and high overall visual performance in any lighting condition. Rates of adverse events did not differ between the Symfony and monofocal groups.

The Symfony lens is approved in more than 50 countries around the world, and has been widely studied, with data from numerous clinical studies involving over 2,000 eyes. In clinical studies, the Symfony lens:
Provided seamless, day-to-night vision. Patients could see objects sharply and clearly at near, intermediate and far away distances, and points in between.
Provided high-quality vision. Some IOLs may leave patients with an inability to focus clearly due to competing wavelengths of light passing through the lens at different angles (known as chromatic aberration), or with vision that is not completely focused because of the shape of the lens (known as spherical aberration). The Symfony lens has been engineered to correct these issues.
Demonstrated a low incidence of halo and glare, which may be perceived as rings or blurring around bright lights. Glare and halo can sometimes affect an individual's ability to drive at night or to perform other visual tasks.

More information can be found from Abbott website.

Yale unveils 3D view of the world inside of cells

New generations of microscopy have opened up a dazzling world that exists in the interior of new cells. But even the best of the new technology has had a trouble of recording the depth of cellular structures – until now.

Yale University researchers, employing some tricks of powerful astronomy telescopes, have discovered a way to view in three dimensions tiny structures within cells such as mitochondria, the cellular power packs, and nuclear membranes that envelope DNA. In accompanying movie, researchers recorded three-dimensional representations of 19 paternal and maternal mouse chromosomes by using colored fluorescent tags attached to proteins that bind them together. The research paper was published online July 7 in the journal Cell.

For more information, please visit Yale website.

Artificial Intelligence May Aid in Alzheimer’s Diagnosis

Machine learning is a type of artificial intelligence that allows computer programs to learn when exposed to new data without being programmed. Now, researchers in The Netherlands have coupled machine learning methods with a special MRI technique that measures the perfusion, or tissue absorption rate, of blood throughout the brain to detect early forms of dementia, such as mild cognitive impairment (MCI), Radiology.

     

"MRI can help with the diagnosis of Alzheimer's disease," said principal investigator Alle Meije Wink, Ph.D., from the VU University Medical Centre in Amsterdam. "However, the early diagnosis of Alzheimer's disease is problematic."

Scientists have long known that Alzheimer's disease is a gradual process and that the brain undergoes functional changes before the structural changes associated with the disease show up on imaging results. Physicians have no definitive way of identifying who has early dementia or which cases of mild cognitive impairment will progress to Alzheimer's disease.

"With standard diagnostic MRI, we can see advanced Alzheimer's disease, such as atrophy of the hippocampus," Dr. Meije Wink said. "But at that point, the brain tissue is gone and there's no way to restore it. It would be helpful to detect and diagnose the disease before it's too late."

For the new study, the researchers applied machine learning methods to special type of MRI called arterial spin labeling (ASL) imaging. ASL MRI is used to create images called perfusion maps, which show how much blood is delivered to various regions of the brain.

The automated machine learning program is taught to recognize patterns in these maps to distinguish among patients with varying levels of cognitive impairment and predict the stage of Alzheimer's disease in new (unseen) cases.

The study included 260 of 311 participants from the Alzheimer Center of the VU University Medical Center dementia cohort who underwent ASL MRI between October 2010 and November 2012.

The study group included 100 patients diagnosed with probable Alzheimer's disease, 60 patients with mild cognitive impairment (MCI) and 100 patients with subjective cognitive decline (SCD), and 26 healthy controls.

SCD and MCI are considered to be early stages of the dementia process and are diagnosed based on the severity of cognitive symptoms, including memory loss and thought- and decision-making problems.

The automated system was able to distinguish effectively among participants with Alzheimer's disease, MCI and SCD. Using classifiers based on the automated machine learning training, the researchers were then able to predict the Alzheimer's diagnosis or progression of single patients with a high degree of accuracy, ranging from 82 percent to 90 percent.

"ASL is a promising alternative functional biomarker for the early diagnosis of Alzheimer's disease," Dr. Meije Wink said.

He added that the application of automated machine learning methods would be useful as a potential screening tool.

"ASL MRI can identify brain changes that appear early in disease process, when there's a window of opportunity for intervention," Dr. Meije Wink said. "If the disease process from SCD to MCI to Alzheimer's disease could be intercepted or slowed, this technique could play a role in screening."

More information can be found from RSNA website.

Nanobubbles Generated by Pulsed Laser Identify & Destroy Cancer Cells

Innovative technology developed by NIH-funded researchers has been able to find and facilitate the killing of cancer cells in mice without harming the nearby healthy tissue. A treatment using this technology in humans could reduce the rate of cancer recurrence or metastasis.

Cancer cells that cannot be removed by surgeons often cause tumors to return or metastasize. In a study published in Nature Nanotechnology in February, Dmitri Lapotko, Ph.D., and his team at Rice University (currently with Masimo Corporation, CA) describe a new way to combat these leftover cancer cells. In this new approach, tiny gold particles have cancer-specific antibodies attached to their surface, which enable the particles to be engulfed in high concentrations and cluster only in cancer cells. These gold clusters, when exposed to a short broad laser pulse, heat and evaporate surrounding liquid, producing a “plasmonic nanobubble.” This nanobubble produces an “acoustic pop” which reveals the cancer cell and then causes an explosion that destroys it from the inside out.

Researchers have examined gold nanoparticles for treating cancer in the past, but the particles lacked specificity; they were unable to differentiate between healthy cells and cancer cells. Lapotko and his team are combatting this problem by combining the use of antibody-coated gold particles with the generation of nanobubbles created with a short laser pulse.

Gold particles can be injected prior to a surgery so they can travel to and cluster in cancer cells. After a tumor is removed in surgery, the laser (near-infrared) pulse is low energy, which can travel safely through a centimeter of tissue, is applied. The laser pulse only causes the nanobubble-induced damage in the remaining cancer cells with gold particles and are the only ones destroyed. This unique approach might be able to reduce the amount of unintended damage done to the patient, especially if the tumor is located in a sensitive area such as the brain, head and neck, breast, or prostate.

“This is a creative and novel approach that combines an understanding of the basic biophysics of heat transfer with the exquisite specificity and chemistry of the targeting antibodies,” said Rosemarie Hunziker, Director of the program for Tissue Engineering at NIBIB. “It could become a powerful tool in our arsenal to fight cancer.”

When surgeons injected these gold particles into mice with cancer before surgery, the initial results were impressive. While 80% of the mice in the operated group that did not receive the gold particle treatment died due to tumors that recurred within 10 days after surgery, none of the mice that received the additional nanobubble treatment regrew tumors in the following two months.

Detailed information can be found from NIBIB website.

FDA approves pelvic floor trainer for OTC sales

Analytica announced that the U.S. Food and Drug Administration (FDA) has approved the PeriCoach® at-home pelvic floor trainer device and smartphone app as an over-the-counter (OTC) treatment for treatment of mild, moderate and stress urinary incontinence (UI) and urge incontinence. A strong pelvic floor is also associated with improved sexual function and satisfaction.


“Women can use pelvic floor exercises or “Kegels” to reduce or eliminate symptoms, and home training with PeriCoach, now available OTC, just got a lot more convenient,” said Leslie Rickey, MPH, MD, Associate Professor of Urology and of Obstetrics, Gynecology and Reproductive Sciences; Fellowship Director, Female Pelvic Medicine and Reconstructive Surgery, Yale School of Medicine. “It is critical that women put their trust in new technology for pelvic floor muscle training that has been medically tested and FDA-cleared, as these products have an internal component and are designed to treat a real medical condition.”

Pelvic floor muscle exercise (PFME) is recommended as first line non-pharmacologic treatment for the millions of women–estimated at one in three--who suffer from urinary incontinence.

Since its introduction in 2015 as a prescription product, PeriCoach, designed by a woman engineer, has been studied and clinically evaluated by clinicians including women’s health physical therapists, urogynecologists, OBGYNs and urogynecological nurses. Data and case reports have been presented and published in peer-reviewed forums.

“As a physical therapist, I feel confident recommending to my patients, and using on myself, vaginal devices that were developed and evaluated first as medical products,” said Heather Jeffcoat, DPT, founder of Fusion Wellness & Physical Therapy and author of Sex Without Pain: A Self-Treatment Guide To The Sex Life You Deserve. “PeriCoach has a well-established profile as an easy-to-use, effective and affordable home pelvic floor trainer. Now, for women who will benefit from PFME, there are no more excuses!”

UI has both lifestyle and financial costs. For example:
• One in three women will experience UI at some point in their lives
• Half of the women who suffer from UI don’t report it and try to manage the condition on their own for 6 years or more before speaking to a clinician
• In the USA alone, adults spend over $20 billion dollars on “routine care” of UI including pads, protection and laundry
• The cost of pads for one woman in the USA for one year is approximately $900

“This approval will bring PeriCoach, and the confidence that comes with it, to women in a convenient way,” said Geoff Daly, CEO Analytica, LTD. “The OTC approval is also a significant milestone for our company in the U.S. We are committed to offering as many women as possible a simple, effective way to deal with a condition that is common but not normal. Over the counter availability of PeriCoach may mean the difference between a day lost to worrying about leaking, and a day confident in enjoying favorite activities.”

More details can be found from http://www.pericoach.com 

China CFDA released 2015 Annual Report for National Adverse Drug Reaction Monitoring

China Food and Drug Administration (CFDA) recently released the 2015 Annual Report for National Adverse Drug Reaction Monitoring，which describes comprehensively the overview of China's national adverse drug reaction monitoring in 2015. In 2015, the national adverse drug reaction monitoring network received 1.398 million adverse drug reaction/event (ADR/ADE) case reports, which increased 5.3% than that in 2014. 393,000 new and serious ADR/ADE cases were reported in 2015, accounting for 28.2% of the total number of the case reports over the same period. ADR reporting coverage rate reached 96.6% at county level; 1044 ADR cases, on average, were reported per million people.

Silk-based tissue chip provides promise for drug testing and implantable devices

Researchers funded by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) have created a new type of tissue chip that can better represent human tissues compared with current chips, and can be more widely used for drug testing. By engineering the chips as a silk gel, the researchers circumvented many of the problems with existing devices. The new chip also has the potential to someday be an implantable treatment itself.



Tissue chips are collections of cells that mimic both the anatomy and physiology of a tissue or organ, making it possible to test treatments in the lab more accurately than using cells grown in a single layer in a dish. To engineer a tissue outside the body, the cells need a three-dimensional structure on which to grow. Such scaffolds are often made of polydimethylsiloxane (PDMS), a silicon-based polymer, and contain microfluidic chambers, representing blood vessels or respiratory tracts, running through them.

These microfluidic systems have various advantages. Some systems are great for developing and testing treatments in the lab; some allow living cells to be embedded within them, while others can replicate a variety of tissue types (bone and bone marrow, say). Other systems have qualities that may allow them to be implanted in the body as part of the treatment itself; one such quality is the ability to eventually degrade away when no longer needed. But, none of the current biomaterials can do all of the above. PDMS is particularly problematic because it is non-degradable, and it sucks up lipids, such as fat molecules or steroid hormones. Many potential medications are lipid based, so PDMS absorbs them before their effects can be measured, making it difficult to test drugs. Additionally, an implant made of PDMS would absorb the body’s lipids, and since lipids are vital to the body’s function, a PDMS microchip can’t be implanted in humans.

To create a system that addresses all of these needs, researchers turned to silk, a naturally derived protein with unique properties that have several benefits: provide different levels of stiffness to match the target tissue; afford long-term stability in a variety of conditions yet still fully degrade over time; and offer transparency so researchers can observe biological processes like enzymatic activity.

“We know that silk is biocompatible so you can use it even inside the body, and it can be programmed to dissolve over time safely,” said Rosemarie Hunziker, Ph.D., program director for Tissue Engineering at NIBIB. “So this might even be an improved design that enables us to build little micro-tissues and make them implantable.” The silk-based system was described online on March 31, 2016 in the journal Biomaterials.

Detailed information can be found from NIH website by following this link.

Next generation ultrasonic surgical device received FDA approval

In an effort to transform energy solutions to make measurable clinical and cost-of-care improvements for healthcare providers and patients globally, Ethicon announces that HARMONIC® HD 1000i has received 510(k) clearance from the U.S. Food and Drug Administration. The HARMONIC HD 1000i is a next generation ultrasonic surgical device designed to address unique challenges in complex open and laparoscopic procedures.



The HARMONIC HD 1000i offers a seamless combination of unmatched precision, unparalleled strength, and optimal efficiency for easier dissection, faster transection and more secure sealing. Its unique blade design delivers more secure seals, even in the most challenging hemostasis conditions, and its increased sealing speed, multi-functionality, and simplified steps allow for optimal efficiency.

The unique shape of Harmonic HD1000i mimics a mechanical dissector, reducing the need to use a separate dedicated dissecting instrument. Unlike previous generations, the HARMONIC® HD 1000i hand piece is integrated into the device, driving clinical performance, and eliminating the need to order, manage, or clean a separate item.

HARMONIC HD 1000i is designed for use in numerous procedures and specialties including Hepato-pancreato-biliary, Thoracic, Colorectal, and Gynecologic Oncology, enhancing surgeons’ ability to handle multiple jobs with expert precision and superior performance.

“HARMONIC HD 1000i is the latest example of our commitment to developing meaningful innovations that can help improve outcomes in critical, complex procedures,” says Grace Chung, Ethicon Vice President, Energy Global Strategic Marketing. “As we move toward the future, HARMONIC HD 1000i will serve as a platform for developing a portfolio of HARMONIC® devices focused on trying to meet surgical needs through our in-depth knowledge of tissue and energy sciences to enable surgeons to reach more patients and restore more lives.”

More information can be found from Ethicon website by following this link.

The bionic cardiac patch - Harvard

Scientists and doctors in recent decades have made vast leaps in the treatment of cardiac problems, particularly since the development in recent years of “cardiac patches,” swaths of engineered tissue that can replace heart muscle damaged during a heart attack.



Through the work of Charles Lieber and others, the next leap may be in sight.

The Mark Hyman Jr. Professor of Chemistry and chair of the Department of Chemistry and Chemical Biology, Lieber, postdoctoral fellow Xiaochuan Dai, and other co-authors conducted a study that shows the construction of nanoscale electronic scaffolds that can be seeded with cardiac cells to produce a bionic cardiac patch. The study is described in a June 27 paper published in Nature Nanotechnology.

“I think one of the biggest impacts would ultimately be in the area that involves replaced or damaged cardiac tissue with pre-formed tissue patches,” Lieber said. “Rather than simply implanting an engineered patch built on a passive scaffold, our works suggests it will be possible to surgically implant an innervated patch that would now be able to monitor and subtly adjust its performance.”

Once implanted, Lieber said, the bionic patch could act similarly to a pacemaker, delivering electrical shocks to correct arrhythmia. But the possibilities don’t end there.

“In this study, we’ve shown we can change the frequency and direction of signal propagation,” he continued. “We believe it could be very important for controlling arrhythmia and other cardiac conditions.”

Unlike traditional pacemakers, Lieber said that because its electronic components are integrated throughout the tissue, the bionic patch can detect arrhythmia far sooner and operate at far lower voltages.

“Even before a person started to go into large-scale arrhythmia that frequently causes irreversible damage or other heart problems, this could detect the early-stage instabilities and intervene sooner,” he said. “It can also continuously monitor the feedback from the tissue and actively respond.”

“And a normal pacemaker, because it’s on the surface, has to use relatively high voltages,” Lieber added.

The patch might also find use, Lieber said, as a tool to monitor responses under cardiac drugs, or to help pharmaceutical companies to screen the effectiveness of drugs under development. Likewise, the bionic cardiac patch could also be a unique platform to study the tissue behavior evolving during some developmental processes, such as aging, ischemia, or differentiation of stem cells into mature cardiac cells.

Although the bionic cardiac patch has not yet been implanted in animals, “We are interested in identifying collaborators already investigating cardiac patch implantation to treat myocardial infarction in a rodent model,” he said. “I don’t think it would be difficult to build this into a simpler, easily implantable system.”

In the long term, Lieber believes, the development of nanoscale tissue scaffolds represents a new paradigm for integrating biology with electronics in a virtually seamless way.

Using the injectable electronics technology that he pioneered last year, Lieber even suggested that similar cardiac patches might one day simply be delivered by injection.

“It may actually be that, in the future, this won’t be done with a surgical patch,” he said. “We could simply do a co-injection of cells with the mesh, and it assembles itself inside the body, so it’s less invasive.”

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