Edwards INSPIRIS RESILIA Valve Receives CE Mark

Edwards Lifesciences Corporation announced it received CE Mark for its INSPIRIS RESILIA aortic valve, the first in a new class of resilient heart valves. Incorporating the advanced RESILIA tissue, the INSPIRIS valve leverages features of the trusted PERIMOUNT Magna Ease valve and includes the proprietary VFit technology, which is designed for potential future valve-in-valve procedures.

A key innovation of the INSPIRIS valve is RESILIA tissue, a new, first-of-its-kind tissue platform that has been in development for more than a decade and builds on Edwards’ 40 years of leadership in tissue technology. RESILIA tissue utilizes Edwards’ integrity preservation technology, which preserves the tissue and provides improved anti-calcification properties and sustained hemodynamic performance. In addition, the valve is stored dry and ready to use.
A press release is available from Edwards website.

Researchers Report Invention of Glucose-Sensing Contact Lens

Blood testing is the standard option for checking glucose levels, but a new technology could allow non-invasive testing via a contact lens that samples glucose levels in tears.

But glucose is a good target for optical sensing, and especially for what is known as surface-enhanced Raman scattering spectroscopy, said Shih, an associate professor of electrical and computer engineering whose lab, the NanoBioPhotonics Group, works on optical biosensing enabled by nanoplasmonics.
This is an alternative approach, in contrast to a Raman spectroscopy-based noninvasive glucose sensor Shih developed as a Ph.D. student at the Massachusetts Institute of Technology. He holds two patents for technologies related to directly probing skin tissue using laser light to extract information about glucose concentrations.
Full story is available from University of Houston website.

Abbott Diabetes Sensing Technology FDA Approved

Abbott announced that the U.S. Food and Drug Administration (FDA) has approved the company’s FreeStyle Libre Pro system, a revolutionary continuous glucose monitoring (CGM) system for healthcare professionals to use with their patients with diabetes.

FreeStyle Libre Pro system is designed to empower healthcare professionals to provide better diabetes management for diabetes patients. The system provides healthcare professionals with a visual snapshot of glucose data, known as the Ambulatory Glucose Profile (AGP), giving a more simplified and clear overview of not only glucose levels, but also patterns and trends within those levels. This valuable information helps healthcare professionals make better, customized treatment decisions for their patients – and for a significantly lower cost than other professional CGM products availablei.
On nearly a daily basis, Eugene E. Wright, Jr., M.D. of Duke Southern Regional Area Health Education Center in Fayetteville, N.C., finds it challenging to effectively treat his patients with diabetes when it comes to decisions around insulin, nutrition and medication. “My patients are often out of range, due to inconsistent self-monitoring and insufficient data from traditional glucose meters that are unable to provide a full view of their glucose levels.”
A press release is availble from Abbott website.

Boston Scientific to Acquire EndoChoice

Boston Scientific and EndoChoice Holdings, Inc. announced the companies have entered into a definitive agreement under which Boston Scientific has agreed to acquire EndoChoice. Upon completion of the transaction, EndoChoice will become part of the Boston Scientific endoscopy business.

EndoChoice develops and commercializes innovative products and services for specialists treating a wide range of gastrointestinal (GI) conditions. The EndoChoice portfolio includes single-use devices, such as resection and retrieval devices, needles, graspers and infection control kits. The company also has strong positions in pathology services and imaging technologies.
Under the terms of the agreement, Boston Scientific will launch a tender offer for all EndoChoice outstanding shares at a cash price of $8.00 per share. Following the tender offer, if successful, all remaining shares of EndoChoice will receive the same consideration paid to stockholders who participated in the tender offer. The total equity value is approximately $210 million and the transaction is expected to close in the fourth quarter of 2016 subject to customary closing conditions.
A press release can be found from Boston Scientific website.

Researchers develop new weapon for hard-to-treat bacterial infections

Health workers may soon have a new weapon in the fight against abscesses—difficult-to-treat bacterial infections that lead to millions of emergency-room visits every year.

Researchers at the University of British Columbia successfully prevented drug-resistant bacteria from forming abscesses, or painful pus-filled lesions, using a peptide, or mini-protein. The peptide worked by disrupting the bacteria’s stress response.
Abscesses are bacterial-induced lesions that are responsible for 3.2 million emergency room visits every year in the United States. Because antibiotics seldom work on them, standard treatment for abscesses involves cutting out the infected tissue or draining it.
Full story is available from UBC wesite.

New technique generates human neural stem cells for tissue engineering, 3D brain models

Tufts University researchers have discovered a new technique for generating rapidly-differentiating human neural stem cells for use in a variety of tissue engineering applications, including a three-dimensional model of the human brain, according to a paper published today in Stem Cell Reports. The work could pave the way for experiments that engineer other innervated tissues, such as the skin and cornea, and for the development of human brain models with diseases such as Alzheimer’s or Parkinson’s.

Researchers converted human fibroblasts and adipose-derived stem cells into stable, human induced neural stem cell (hiNSC) lines that acquire the features of active neurons within as few as four days, compared to the typical four weeks, according to the paper. The neural stem cells are hardy, can be frozen, passaged indefinitely, and have unique attributes that allow them to grow well in vitro with other cell types, such as skeletal muscle. When injected into an early stage chicken embryo, the hiNSCs incorporated into the brain as well as the neurons of the peripheral nervous system that innervate tissues in a developing limb.
Full story is available from Tufts University website.

Draper’s first neural interface in humans

Draper engineers are rapidly moving toward realizing the technology that can provide a natural sense of feeling and proprioception—the ability to process and integrate limb orientation information—to patients who have lost a limb. The implantable device can ultimately allow those with a prosthetic limb a much more intuitive, controlled user experience with their prosthetic and an improved interaction with the world around them.

This research is funded by the Defense Advanced Research Projects Agency’s (DARPA) Hand Proprioception and Touch Interfaces (HAPTIX) program. The University of Texas Southwestern (UTSW) conducted successful testing, on behalf of Draper, of the novel electrode component in animal studies. Next, they will be tested in humans as early as the fall of 2016 as part of a follow-on Phase II contract DARPA awarded Draper in April.

The electrodes of Draper’s HAPTIX system deliver electrical signals to nerves in the forearm, much the same way the human nervous system does, creating an artificial sensory feedback. Draper’s approach is unique in that the electrodes wrap around as well as directly interact with the nerves, thus allowing for more precise stimulation and a more real sense of touch for amputees. “Draper makes inherently safe systems that work, whether we’re designing an active implantable medical device or a fault-tolerant computer system for space missions,” said Dr. Philip Parks, Draper’s HAPTIX program manager.

Full story is available from Draper website.

Boston Scientific Receives CE Mark For LOTUS Edge Valve System

Boston Scientific has received CE Mark for the LOTUS Edge™ Valve System, the company’s next generation transcatheter aortic valve implantation (TAVI) technology. The LOTUS Edge valve system is indicated for aortic valve replacement in patients with severe aortic stenosis who are considered at high risk for surgical valve replacement. Instead of open heart surgery, the replacement valve is delivered via transcatheter percutaneous delivery, a minimally invasive procedure involving a small incision to gain access to a blood vessel.

In comparison to the Lotus™ Valve System, this next iteration incorporates a more flexible, lower profile catheter designed to improve ease of use and accommodate tortuous anatomy. Another differentiating feature of the LOTUS Edge valve system is the inclusion of Depth Guard™, a design element intended to reduce the need for a permanent pacemaker (PPM).
A press release is available from Boston Scientific website.

Research Finally Reveals Reason for Perplexing Red Skin Disease

Dr. Amy Paller, who has spent 30 years researching the disorder, for the first time has found the reason the disease causes the red skin and has a promising biologic drug to begin testing soon in clinical trials.
In a new study published in the Journal of Allergy and Clinical Immunology, Paller, the Northwestern Medicine chair of dermatology, together with Dr. Emma Guttman-Yassky of Mount Sinai Medical School, discovered that an arm of the immune system – the Th17 pathway – in these patients is way too active, and the higher its activity, the worse the disease severity.
Paller is about to launch a clinical trial to test a new biologic (a cutting-edge drug) for it, with the goal of targeting and calming down this pathway.

More information is available on Northwestern University website.

The 7th China International Medical Device Regulatory Forum held in Chengdu

On September 11-13, 2016, the 7th China International Medical Device Regulatory Forum was held in Chengdu, China. Jiao Hong, Vice Minister of China Food and Drug Administration (CFDA) attended and addressed the opening ceremony of the forum.
With the theme of “standardizing medical device clinical trials, guaranteeing the authenticity of clinical data,” the forum invited domestic and foreign experts to give keynote speeches, and set up more than ten sub-forums on regulatory and industry hot topics, including forums on medical device innovation and post-market surveillance. Directors from CFDA’s medical device regulatory departments and technical institutions interpreted related policies, laws, regulations and technical requirements of China. Experts from domestic and foreign medical device regulatory and technical departments and medical device industry exchanged latest information on medical device related regulations, new products and new technologies.

6 little molecules could help stop both Ebola and cancer

Researcher Christopher Stroupe at School of Medicine, University of Virginia, has his eye on six little molecules that could be the key to new treatments for both Ebola and cancer. The molecules, which act together as a single unit known as HOPS, are essential for Ebola to infect cells and for cancer cells to grow and survive. As such, they represent a shared weakness – a weakness Stroupe is seeking to exploit. To do that, he is creating a new tool to produce a purified form of HOPS that would facilitate the development of drugs targeting the molecules. By blocking HOPS in human cells, he hopes, doctors can cut the legs from under Ebola and cancer.
Full story can be found from University of Virginia website.

BD Unveils Next Generation Wireless Point-of-Care Diagnostic Device

BD announced the launch of its next generation wireless rapid diagnostic system for detection of influenza A and B, respiratory syncytial virus (RSV) and group A strep, with new traceability and secure patient health record documentation features and functionality.

The new wireless BD Veritor™ Plus System provides health care providers and laboratorians in physician offices, clinics, hospitals and integrated delivery networks (IDNs) with objective, lab-quality immunoassay test results within minutes. This rapid and accurate solution streamlines the point-of-care (POC) diagnostic workflow and enables providers to quickly review patient results to assist in determining the appropriate treatment in a single consultation. The system can help detect influenza A and B, respiratory syncytial virus (RSV) and group A strep while the patient is still on site, which enables faster decision making for an earlier intervention opportunity.

A press release can be found from BD website.

3-D printed structures “remember” their shapes

Engineers from MIT and Singapore University of Technology and Design (SUTD) are using light to print three-dimensional structures that “remember” their original shapes. Even after being stretched, twisted, and bent at extreme angles, the structures — from small coils and multimaterial flowers, to an inch-tall replica of the Eiffel tower — sprang back to their original forms within seconds of being heated to a certain temperature “sweet spot.”

For some structures, the researchers were able to print micron-scale features as small as the diameter of a human hair — dimensions that are at least one-tenth as big as what others have been able to achieve with printable shape-memory materials.

Full story is available from MIT website.

Smart nanoparticles overcome multidrug-resistant cancer

Multidrug resistance (MDR) is the mechanism by which many cancers develop resistance to chemotherapy drugs, resulting in minimal cell death and the expansion of drug-resistant tumors. To address the problem of resistance, researchers have developed nanoparticles that simultaneously deliver chemotherapy drugs to tumors and inhibit the MDR proteins that pump the therapeutic drugs out of the cell. The process is known as chemosensitization, as blocking this resistance renders the tumor highly sensitive to the cancer-killing chemotherapy.

The two publications report on the engineering of two separate nanoparticles that test different strategies for achieving chemosensitization of cancer cells. The first targets MDR breast cancer. The engineered round nanoparticle is made of several layers. The center of the particle is loaded with the anti-cancer drug doxorubicin. The drug is surrounded by a water-repelling (hydrophobic) capsule to protect it from the watery environment when the particle is injected into the circulatory system of an experimental animal or individual with cancer.
The particle has several outer layers with different properties. One of the outermost components, a molecule called PEG, is hydrophilic (mixes with water) and helps the particle move through the bloodstream until it encounters the breast tumor cells. Another component on the surface of the particle, biotin, functions to bind specifically to the cancer cells and helps the drug-carrying nanoparticle to enter the cell.

Once inside the breast cancer cell, a fourth component called curcumin, which is intertwined with the doxorubicin center, is released along with the doxorubicin. The curcumin is the component that blocks the cell machinery that would pump the doxorubicin out of the cell. Without the ability to pump out the medicine, the cell is exposed to very high concentration of doxorubicin, which kills the breast cancer cells.

Full story can be found from NIH website.

Experimental drug could stop melanoma

An experimental cancer drug works differently than intended and shows significant promise for stopping melanoma and possibly other forms of cancer, research from the UVA School of Medicine suggests. The findings also indicate the drug may be effective against melanomas that have resisted other forms of treatment.

The drug, pevonedistat, is already being tested in people. Scientists have been uncertain exactly how it kills cancer cells, as it shuts down many different cellular proteins – hundreds if not thousands. But the UVA researchers, led by Tarek Abbas, PhD, of the Department of Radiation Oncology and the UVA Cancer Center, have determined that the drug acts upon a particular protein that melanomas and other cancers rely on to replicate with great speed and deadly effect. By denying the cancers this essential ingredient, doctors may be able to stop melanomas and other forms of the disease.

For more information please visit University of Virginia website.

ResMed Expands COPD Offering

ResMed welcomed positive results from the independent Home Oxygen Therapy- Home Mechanical Ventilation (HOT-HMV) study[i] regarding the benefits of home non-invasive ventilation (NIV). Portable oxygen therapy, remote monitoring technology and home NIV are key components of ResMed’s COPD management offering.
The HOT-HMV study shows that the addition of home NIV to home oxygen therapy improves admission-free survival in hypercapnic COPD patients (those with high levels of carbon dioxide in the blood) following a life-threatening exacerbation of COPD requiring acute NIV.1 This includes an increase in patients’ median (hospital) admission-free survival from 1.4 months in the group receiving HOT only, to 4.3 months in the group receiving HOT plus home NIV, with an adjusted hazard ratio of 0.49 (0.31-0.77); p=0.002.
ResMed home NIV solutions are also connected to AirView™, ResMed’s cloud-based patient management system, which ensures healthcare professionals can remotely identify patients in need of attention, make informed treatment decisions and deliver timely interventions. In addition to helping physicians better manage COPD patients on home NIV, AirView also enables home care providers to optimise business efficiencies and allows them to focus existing resources on high-value activities. Resmed’s cloud-connected ventilators provide peace of mind to patients and their families and help improve their overall experience living with COPD.

A press release can be found from ResMed website.

BD Announces New Software Release For Pyxis Enterprise Solution

BD announced general availability of the latest software release of Pyxis™ ES System, delivering patient safety and workflow benefits for health systems’ medication management.
Key innovations and enhancements in the new software version include:

• Advanced server scalability and optimization to meet the needs of growing health systems with flexible deployment options and centralized database management features.
• Expanded return and waste processes to support patient safety and clinical efficiency with workflow, documentation and interface enhancements.
• Support for advanced half-height CUBIE™ drawers and pockets, bringing enhanced security and reliability to the flexible storage space and configurability options for which CUBIE technology is known.
• New Medication Label Module that can print a patient-specific medication label upon removal to support patient safety and compliance with Joint Commission requirements. Proper medication labeling can help reduce medication errors, missing doses, and waste caused by mislabeled, open multi-use medications.
• Enhanced server functionality to provide more flexibility through medication configuration and user permissions, plus improved reporting features. These features support system and data security as well as medication safety and standardization.

The Pyxis ES platform promotes a patient-centric healthcare model, leveraging healthcare information technology systems and Active Directory integration to enable a single health system formulary, simplified identity management and workflow enhancements. The platform enables pharmacists to manage medications remotely and eliminate redundant tasks.  Nurses can readily access secured medications using safe, simple workflows centered on the patient.

A press release can be found here.

Self-destructing battery to power ‘transient’ devices

Self-destructing electronic devices could keep military secrets out of enemy hands. Or they could save patients the pain of removing a medical device. Or, they could allow environmental sensors to wash away in the rain.

Making such devices possible is the goal of a relatively new field of study called “transient electronics.” These transient devices could perform a variety of functions – until exposure to light, heat or liquid triggers their destruction.
Reza Montazami, an Iowa State University assistant professor of mechanical engineering and an associate of the U.S. Department of Energy’s Ames Laboratory, has been working on transient technology for years. The latest development from his lab is a self-destructing, lithium-ion battery capable of delivering 2.5 volts and dissolving or dissipating in 30 minutes when dropped in water. The battery can power a desktop calculator for about 15 minutes.

A full story can be found from Iowa State University website.

Spirometrix receives CE for its POC Breathalyzer

Spirometrix, an emerging technology healthcare company focused on research, development and commercialization of novel breath analysis devices for applications in disease diagnosis and management, announced today that its Fenom PRO™ Point-of-Care Breathalyzer has received CE marking and can now be sold in Europe.
Spirometrix Inc., founded in 2011 by Dr. Solomon Ssenyange and Ryan Leard as a personal mission to aid asthma patients in the management of their ailment, focuses on the development and commercialization of novel breath analysis devices for application in diagnosis and management of asthma. In recent years, non-invasive measurement and monitoring of the fraction of exhaled nitric oxide (FeNO) in exhaled breath has become established as the biomarker of asthma. The sensor based technology was licensed from Professor Prabir Dutta’s innovative laboratories at The Ohio State University as the company was founded.

“FeNO monitoring in the management of asthma patients at the point of care has the potential to optimize asthma therapy, improve compliance of medication use and decrease the need for emergency visits and hospitalization,” added James Wolfe, M.D., Clinical Professor of Medicine at Stanford University and a Scientific Advisor to Spirometrix. “It should be noted that both American Thoracic Society and European Respiratory Society have issued guidelines recommending FeNO testing for the assessment, management, and long-term monitoring of asthma.”

A press release can be found from Spirometrix website.

Nestlé acquires Phagenesis aiming at dysphagia

Nestlé Health Science (NHSc) and Phagenesis announced that NHSc is entering into a staged, milestone-based acquisition of Phagenesis, a medical device company that has developed a new treatment for dysphagia.

Under the terms of the agreement, NHSc will make an upfront payment, followed by milestone-based funding, while Phagenesis completes the clinical evaluation of Phagenyx®. The staged acquisition will be based upon successful completion of European and US development programs anticipated by 2019. Financial terms have not been disclosed.

A press release can be found from Phagenesis website.

Philips and Qualcomm announce strategic collaboration to advance personalized connected health care

Royal Philips and Qualcomm Incorporated through its subsidiary, Qualcomm Life, Inc., agreed on a strategic technology collaboration to advance connected health across the health continuum — from healthy living and prevention to chronic care management and home care. The companies are teaming up to leverage each other’s respective leading capabilities – Philips’ leadership in connected health informatics and regulated health care cloud data management and analytics, and Qualcomm Life’s expertise in secure, medical-grade device connectivity and integration. This collaboration will enable both companies to offer care providers enhanced, scalable, connected care solutions and services within a secure global ecosystem.

As part of the collaboration, Qualcomm Life will leverage Philips HealthSuite as a global, secure, data management and storage solution for its medical-grade 2net Platform, allowing Qualcomm Life to tap into the value of health data through data normalization, aggregation and analytics. Qualcomm Life customers can now have direct access to build applications, integrate with electronic health record systems, store normalized data, run analytics, and manage authorization and consents in a compliant and secure environment.

A press release can be found from Philips website.

Bluegrass Vascular Receives CE for The Access Catheter System

Bluegrass Vascular announced that it has received CE Mark approval and is launching limited commercial sale of its Surfacer® Inside-Out® Access Catheter System. The Surfacer System is indicated for obtaining central venous access to facilitate catheter insertion into the central venous system via a novel Inside-Out approach.

A press release can be found from Bluegrass Vascular website.

Revascularization better for peripheral arterial disease

Patients with intermittent claudication, a form of peripheral arterial disease, who had circulation-restoring procedures called revascularization had better quality of life and fewer symptoms a year later than patients who underwent medical management in a recent study.

Emily Beth Devine, UW associate professor of pharmacy,  and her colleagues, compared the effectiveness of two treatments for intermittent claudication: a medical management program consisting of walking exercise, medicines, and smoking cessation counseling; and revascularization by surgically unblocking clogged blood vessels or by implanting tiny wire mesh tubes called stents into the vessels to help keep arteries open.
The study was conducted at 15 clinics associated with 11 hospitals in Washington state. Participants were 21 years or older with newly diagnosed or established intermittent claudication. A total of 323 adults were enrolled, with 282 (87 percent) receiving the medical treatment program. At the start of the study, the average duration of disease was longer for participants who received the medical intervention program, while those who underwent revascularization reported more severe disease.

Full story can be found from University of Washington website.

Battery-Free Wearable Patch Can Help Monitor Health

A battery-free electronic patch that sticks onto skin like a temporary tattoo can be powered wirelessly by smartphones to help monitor health, researchers say.

Now researchers have developed a stretchable, wearable ultra-thin device that can not only wireless transmit health data, but also is wirelessly powered via near-field communication transmissions. Smartphones, tablets and other consumer electronics use near-field communications with the Apple Pay and Android Pay wireless payment schemes.
The battery-free nature of this patch makes it five to 10 times thinner than comparable gadgets, says study leader John Rogers, a materials scientist at the University of Illinois at Urbana-Champaign.

Full story is available from IEEE Website.

Inseal Medical Receives CE Mark for Large Bore Vascular Closure Device

InSeal Medical Ltd., a privately held medical device company, announced that it has received CE Mark approval for its InClosure VCD, a large bore vascular closure device. The InClosure VCD is a first-in-class, intravascular closure device based on InSeal Medical’s proprietary and patented technology.
A press release can be found from InSeal Medical Website.

Nanovaccine could enhance cancer immunotherapy

NIBIB researchers have created a nanovaccine that could make a current approach to cancer immunotherapy more effective while also reducing side effects. The nanovaccine helps to efficiently deliver a unique DNA sequence to immune cells – a sequence derived from bacterial DNA and used to trigger an immune reaction. The nanovaccine also protects the DNA from being destroyed inside the body, where DNA-cutting enzymes are pervasive, as well as outside of the body when exposed to warm temperatures while being stored or transported. The researchers successfully tested the nanovaccine in mice and detailed their work in the March 2016 issue of the journal Nanoscale.

Tumors evade the immune system by suppressing its ability to recognize and kill cancer cells. The goal of immunotherapy is to normalize and harness the body’s immune system so that it can more effectively fight the Tumors.

Full story is available from NIBIB Website.

Medtronic Launches New Insulin Pump with SmartGuard Technology in US

Medtronic announced the U.S. commercial launch of its MiniMed 630G system with SmartGuard technology FDA approved for the treatment of people with diabetes mellitus sixteen years of age and older. The MiniMed 630G features a new insulin pump hardware platform and new user-friendly design that combines personalized diabetes management with industry-leading clinical performance. The MiniMed 630G system is the newest member of the MiniMed family-the most prescribed integrated insulin delivery system brand in the world.



The MiniMed 630G system exclusively uses the CONTOUR®NEXT LINK 2.4 blood glucose meter from Ascensia Diabetes Care to provide blood glucose test results that have been shown to be highly accurate. The meter automatically transmits blood glucose results to calculate boluses using the Bolus Wizard® calculator and to calibrate the CGM sensor, which helps prevent manual entry errors. It also allows patients to discreetly give themselves a bolus of insulin remotely from the meter, providing added convenience to help patients manage their diabetes effectively.

A press release can be found from Medtronic Website.

Microchip for measurement of single-cell growth

A new technique invented at MIT can precisely measure the growth of many individual cells simultaneously. The advance holds promise for fast drug tests, offers new insights into growth variation across single cells within larger populations, and helps track the dynamic growth of cells to changing environmental conditions.

The technique, described in a paper published in Nature Biotechnology, uses an array of suspended microchannel resonators (SMR), a type of microfluidic device that measures the mass of individual cells as they flow through tiny channels. A novel design has increased throughput of the device by nearly two orders of magnitude, while retaining precision. The paper’s senior author, MIT professor Scott Manalis, and other researchers have been developing SMRs for nearly a decade.

Full story is available from MIT Website.

BD Submits Pre-Market Approval Application to FDA for Onclarity HPV Test

BD submitted a pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the BD Onclarity™ HPV Assay, its human papillomavirus (HPV) test.

The BD Onclarity HPV Assay PMA is supported by data collected during a two-year, prospective, multi-center clinical trial with more than 33,000 women enrolled ― one of the largest clinical trials ever conducted by BD.

The submission seeks approval for use of the BD Onclarity HPV assay with BD SurePath specimens for detection of 14 high-risk HPV types to determine the need for referral to colposcopy for women 21 and older with abnormal (ASC-US) Pap test results and in women 30 years and older, the use of BD Onclarity together with cervical cytology to adjunctively screen for high-risk HPV and individually identify HPV genotypes 16, 18 and 45. BD is also seeking the use of the test as a first-line primary cervical cancer screening test for women 25 years and older.

BD intends to ultimately seek approval using HPV genotyping beyond 16, 18 and 45, in line with the genotyping capabilities of the assay’s design.

A press release can be found from Becton, Dickinson and Company (BD) Website.

Mayo Clinic Proceedings Publishes New Insulin Injection and Infusion Recommendations

Medical Journal ‘Mayo Clinic Proceedings’ published new insulin delivery recommendations for health care professionals caring for insulin-using patients, including the results from the largest injection technique survey ever performed for people with diabetes.

Three articles will appear in the September print issue of the publication – with new research showing that many patients with diabetes are using insulin incorrectly and not getting the maximum benefit from this life-saving medication. Proper injection and infusion technique is critical to insulin’s consistent action and may be as important as the medication or diet and activity. These findings provide a clear roadmap for better clinical management of insulin use for people with diabetes and for their health care providers.
Dr. Kenneth Strauss, co-author and medical director, BD Europe stated, “FITTER and these publications set new standards for insulin delivery.  Tools are embedded in these publications, which will allow patients and professionals to quickly translate them into everyday practice.  If these recommendations become routine practice, we should soon see the improved outcomes that come from optimized insulin delivery.”
The analysis of this landmark injection technique survey is the result of a BD (Becton, Dickinson and Company) sponsored international workshop known as the Forum for Injection Technique & Therapy Expert Recommendations (FITTER). This international congress included 183 diabetes experts from 54 countries and took place October 2015 in Rome. Two of the papers published in Mayo Clinic Proceedings address the key findings from this injection technique survey and a third paper presents the new insulin delivery recommendations, intended to help shape local and regional injection guidelines around the world.
Insulin Injection Technique Survey Key Takeaways:

• Many patients taking insulin are using needles that are longer and thicker than recommended, and are reusing the needles frequently.
• One-third of those taking insulin have nodules or bumps in the fat tissue at their injection sites (a condition known as lipohypertrophy, or lipos). This is associated with incorrect rotation of injection sites and is also problematic with insulin infused via pumps.
  • If patients inject into lipos, the absorption of insulin is blunted and highly variable. This may cause patients to react by injecting more insulin, which puts them at risk of unexpected glucose swings and dangerous hypoglycemia.
  • Despite using more insulin, patients with lipos have worse glucose control, increasing their risk for eye, kidney and nerve complications.

The third publication, “New Recommendations for Insulin Delivery” is based on these survey findings as analyzed by participants of the FITTER international congress.
The new FITTER recommendations include:

• Use the shortest available pen needle (currently 4mm) or syringe needle (currently 6mm) for all injecting patients, regardless of age, sex or body size.
  • The shortest needle length is less painful, has higher patient acceptance and gives comparable glucose control.
  • By contrast, excessively long needles increase a patient’s risk of intramuscular injections, which can accelerate insulin uptake and action, increasing glucose variability and risk of hypoglycemia.
• Correct rotation of injection sites can reduce the frequency of lipohypertrophy. Such reductions should improve glycemic control and clinical outcomes, reduce insulin consumption and thereby lower health care costs.
• Limit use of pen needles and syringes to one-time, as reusing needles is not an optimal injection practice because they are no longer sterile after use.

The new FITTER recommendations also contain important sections dealing with optimal insulin pump and infusion set guidance, as well as recommendations for use of safety-engineered injection devices for people who give injections, such as healthcare workers.  In conclusion, adherence to these recommendations may lead to better injection and infusion experience for patients, safer injections by HCWs, and improved glucose control, which reduces the risk of long-term complications and saves health care dollars.
“BD’s purpose of advancing the world of health expands far beyond the products we make. We partner with health care professionals around the world to publish evidence-based practices in peer-reviewed publications and create educational tools that can help people with diabetes achieve better clinical outcomes,” said Dr. Laurence Hirsch, co-author and worldwide vice president of Medical Affairs for BD Diabetes Care. “These new recommendations will help health care professionals and people with diabetes who take insulin to better manage their treatment.”
Dr. Anders H. Frid, lead author and Diabetologist at the Skane University Hospital, Malmö in Sweden added, “For more than 30 years, I have been studying injection sites, injection technique and insulin absorption. It is a wonderful accomplishment to now have comprehensive and evidence-based recommendations around proper needle use and good injection practices published in a major journal for health care professionals and people with diabetes around the world to access.”

Source: Becton, Dickinson and Company (BD)

Wireless connectivity for implanted devices

University of Washington researchers have introduced a new way of communicating that allows devices such as brain implants, contact lenses, credit cards and smaller wearable electronics to talk to everyday devices such as smartphones and watches.

This new “interscatter communication” works by converting Bluetooth signals into Wi-Fi transmissions over the air. Using only reflections, an interscatter device such as a smart contact lens converts Bluetooth signals from a smartwatch, for example, into Wi-Fi transmissions that can be picked up by a Smartphone.
“Wireless connectivity for implanted devices can transform how we manage chronic diseases,” said co-author Vikram Iyer, a UW electrical engineering doctoral student. “For example, a contact lens could monitor a diabetic’s blood sugar level in tears and send notifications to the phone when the blood sugar level goes down.”
Due to their size and location within the body, these smart contact lenses are too constrained by power demands to send data using conventional wireless transmissions. That means they so far have not been able to send data using Wi-Fi to smartphones and other mobile devices.
Those same requirements also limit emerging technologies such as brain implants that treat Parkinson’s disease, stimulate organs and may one day even reanimate limbs.
Full story can be found from University of Washington website.

Foundation Medicine Adds New Immunotherapy Features to Its Market-Leading Products

Foundation Medicine announced the addition of new clinical markers to its FoundationOne® and FoundationOne® Heme products, which are designed to enhance oncologists’ insight into potential response to immunotherapies. This ability to determine TMB and MSI from its assays is additional to the existing comprehensive profiling of genes provided by FoundationOne and FoundationOne Heme. Taken together, the molecular information provided by Foundation Medicine provides unique insights to physicians and enhances their ability to predict response to immunotherapies, identify targeted therapeutic options, and improve access to clinical trials all from a single assay.

“Cancer immunotherapies are at the forefront of cancer treatment, and new, quantitative approaches are needed to predict clinical responses to this important, but also expensive, class of therapies,” said Vincent Miller, M.D., chief medical officer of Foundation Medicine. “Prior to our ability to measure TMB and MSI with FoundationOne, these biomarkers could only be detected separately, either through tests such as immunohistochemistry, polymerase chain reaction (PCR) or whole exome sequencing. Importantly, high-quality, predictive TMB scoring can only be accurately performed with sophisticated algorithms developed to work with broad, hybrid capture-based platforms that can analyze all relevant alterations simultaneously. Integrating this capability to measure TMB and MSI with one tissue sample, and reported in one test, represents an important advance in clinical care.”

A growing body of evidence, most recently presented at the American Society of Clinical Oncology (ASCO) annual meeting this year, validates the ability of a new independent marker, TMB, to predict the likelihood of response to cancer immunotherapies. TMB is reported as the total number of DNA mutations per megabase in a tumor sequence. This phenomenon has been validated across a wide range of tumor types, including advanced bladder cancer, lung cancer, breast cancer, colorectal cancer, advanced head and neck cancer and melanoma. Some tumors develop high TMB as a result of defective mismatch repair of DNA, a condition in which the length of certain DNA areas becomes more widely varied than normal. This condition, which is referred to as MSI-high and MSI-high tumors, almost always has a high TMB.

“The ability to accurately measure multiple biomarkers simultaneously, including TMB and MSI, is an important advance for the field of cancer immunotherapy, and one that is unique to Foundation Medicine,” said Thomas George, M.D., GI oncology program director, University of Florida. “Foundation Medicine’s combination of advanced sequencing platforms and highly-specific algorithms gives me access to all relevant genomic biomarkers for my patients at once, helping to save both time and tissue.”

“We were encouraged by the findings presented at ASCO, including the possibility of identifying patients more likely to benefit from checkpoint inhibitor immunotherapy,” said Dr. Miller. “Our goal is to empower doctors and patients with a full range of relevant, actionable genomic information, and we’re excited to offer our distinctive solution to estimate TMB and MSI simultaneously and with exceptional accuracy, supported by sophisticated algorithms and rooted in contextual insights from our knowledgebase FoundationCORE™. This is something no other next-generation sequencing platform offers.”

Independent of the FoundationOne and FoundationOne Heme assays, Foundation Medicine also offers testing for PD-1 and PD-L1 protein expression, providing, in combination with the FoundationOne assays, a full suite of cancer immunotherapy assays for oncologists.

A press release can be found from Foudation Medicine Website.

The First FDA Cleared Concussion-Specific Medical Device

ImPACT, the most widely-used and most scientifically-validated computerized neurocognitive concussion management tool available, is the first medical device of its kind to receive U.S. Food and Drug Administration (FDA) de novo clearance. FDA clearance has been granted under Computerized Cognitive Assessment Aid for Concussion, a new category for a device that uses an individual’s score(s) on a battery of cognitive tasks to provide an indication of the current level of cognitive function in response to concussion. FDA de novo clearance signifies ImPACT has met the FDA’s premarket requirements to demonstrate accuracy, validity, and reliability for concussion management and specifically states that ImPACT will “aid in the assessment and management of concussion.”



“ImPACT’s FDA clearance is a huge step forward for the industry, for athletes and others who are at-risk of concussion-related injuries, as well as for licensed, trained medical professionals everywhere,” said Michael Wahlster, Chief Executive Officer of ImPACT Applications. “ImPACT Applications has a proven commitment to science, research, and innovation. That is why a global network of hospitals, clinics, youth sports organizations, and professional athletes utilize and trust ImPACT.”

ImPACT is the only concussion-specific tool with more than 14 years of independent evaluation and scientific validation. In addition, over 250 peer-reviewed articles, of which half were independently conducted clinical research studies, have built ImPACT’s foundation of trust and value. By achieving FDA clearance in a new category, ImPACT Applications continues to fulfill its role as a pioneer in concussion management by providing customers the safest and most effective concussion management tools on the market.

FDA clearance comes at a time when concussion awareness is growing rapidly. The FDA’s clearance is evidence that ImPACT is an effective tool that adds another level of accountability to the return-to-activity decisions of health care professionals who use ImPACT as part of their concussion management protocol.

FDA de novo clearance is one of several steps ImPACT Applications is taking to advance the science of concussion management, and ImPACT Applications looks forward to continuing to enhance the knowledge base.

A press release can be found from ImPact Website.

Roche launches innovative Accu-Chek Guide blood glucose monitoring systemGuide blood glucose monitoring system

Roche launches of the Accu-Chek® Guide, the next-generation blood glucose monitoring system. This new system is designed to make everyday blood glucose (BG) monitoring easier with features such as the spill-resistant SmartPack test strip vial, which helps users to remove just one strip at a time and avoid spillage or contamination. The Accu-Chek Guide system also provides for advanced accuracy, which enables reliable diabetes management. “As the global leader in diabetes management we are dedicated to supporting people with diabetes, in thinking less about their daily therapy routines. We are very excited to introduce this innovative system, that simplifies blood glucose monitoring and improves the testing experience,” said Roland Diggelmann, CEO Roche Diagnostics. First markets to launch the new system are Denmark, Switzerland and Australia. Morecountries will follow subsequently starting in early 2017.



The Accu-Chek Guide system enables on-board pattern detection that helps to increase awareness of too high or too low glucose readings as well as Bluetooth Low Energy connectivity to the Accu-Chek Connect diabetes management solution via a mobile app. This cloud-based solution guarantees a secure online data exchange and automatic data logging. People with diabetes, caregivers, and healthcare providers can share diabetes information virtually anywhere for timely advice and remote monitoring. Such telemedicine solutions can help people with diabetes and their caregivers manage diabetes more efficiently and give them peace of mind and a feeling of relief. Hence, 97% of 197 participants in a recently published study from France and the US agreed that the system was very easy to use and offers a better testing experience.

The Accu-Chek Guide system not only fulfills current accuracy standards but delivers even tighter 10/10 accuracy for more reliable results3. Consistently accurate measurements are essential for reliable BG monitoring and deriving the correct therapy decisions. Large deviations of the measured BG values from the true glucose levels can result in higher HbA1c levels, glycemic excursions and markedly increased rates of hypoglycemic events, as a recently published retrospective study revealed. In addition, studies have demonstrated that only about half of the BG meters evaluated meet the minimum accuracy requirements as defined by the ISO 15197:2013/EN ISO 15197:2015 Standard.

A press release can be found from Roche Website.

Masimo continuous respiration rate Monitor CE approved

Masimo announced the CE Marking of RAS-45, a single-use adult and pediatric acoustic respiration sensor for rainbow Acoustic Monitoring® (RAM™) of respiration rate (RRa®).



Continuous monitoring of respiration rate is especially important for post-surgical patients receiving patient-controlled analgesia for pain management. The Anesthesia Patient Safety Foundation (APSF) and The Joint Commission recommend continuous oxygenation and ventilation monitoring for all patients receiving opioid-based pain medications.1,2 RAM noninvasively and continuously measures respiration rate using an innovative adhesive sensor with an integrated acoustic transducer, such as Masimo’s RAS-125c and now RAS-45, that is applied to the patient’s neck. Using acoustic signal processing that leverages Masimo’s breakthrough Signal Extraction Technology (SET®), the respiratory signal is separated and processed to display continuous acoustic respiration rate (RRa). RRa has been shown to be accurate, easy-to-use, and reliable, and to enhance patient compliance.RRa may facilitate earlier detection of respiratory compromise and patient distress, offering a breakthrough in patient safety for post-surgical patients and for procedures requiring conscious sedation.



RAS-45 is designed to facilitate placement on and improve attachment to the neck, but with a smaller adhesive profile than the RAS-125c. It is flexible and uses a transparent adhesive. Like the RAS-125c, it operates with Masimo MX technology boards to measure RRa and display the acoustic respiration wave form. RAS-45 maintains the same performance parameters, range, and accuracy specifications as RAS-125c. Both sensors are for patients who weigh more than 10 kg.

Joe Kiani, Founder and CEO of Masimo, commented, “RAM harnesses the power of our breakthrough signal processing technology, using Masimo SET® and rainbow® technologies, and applies those achievements to a respiratory measurement derived from the sound of breathing. Studies have found that RAM RRa is more sensitive to detecting respiratory pause5 and yet easier for clinicians and patients to use.

A press release can be found from Masimo Website.

New sheath provides exceptional access to challenging anatomies and branch vessels

W. L. Gore & Associates, Inc. announced the commercial availability of the GORE® DrySeal Flex Introducer Sheath, after recently gaining clearance for use by regulatory bodies in the U.S., Europe, Canada, and Australia. The device is designed with a distinct combination of enhanced flexibility, kink resistance, and a hydrophilic coating to facilitate access to challenging anatomies and branch vessels, such as the common iliac arteries, during endovascular repair procedures.



The 12 Fr x 45 cm sheath configuration is engineered specifically for use with the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE), the only device indicated in the U.S. for endovascular repair (EVAR) of common iliac artery aneurysms or aortoiliac aneurysms. An EVAR often requires multiple wires and catheters be transferred into the vessel via an introducer sheath, which can lead to blood loss through the sheath valve. The sheath’s exclusive DrySeal valve was designed to minimize blood loss, enabling the introduction of multiple devices with proven hemostasis control.

“Nearly a third of patients being considered for EVAR have an aneurysm that extends to the iliac artery. The IBE is a trusted solution in such cases, but previously no introducer sheaths designed for use with this device existed,” said Mr. Marcus Brooks, Consultant Vascular Surgeon, North Bristol NHS Trust. “With the GORE DrySeal Flex Introducer Sheath, I now have a sheath specifically designed for use with the IBE and flexible enough for easy access to the iliac branch vessels.”

The new sheath leverages technology from Gore’s long-trusted GORE® DrySeal Sheath, which features a hydrophilic coating for improved access into vessels. In addition, the GORE DrySeal Flex Introducer Sheath offers an optimized profile and new configurations which include working lengths of 33, 45, and 65 cm.

“The availability of this new sheath provides more options to treat a broader range of patient anatomy,” said Jason T. Lee, MD, Professor of Surgery at Stanford School of Medicine. “The sheath supports my cases from start to finish, offering confidence for a wider range of applications than ever before.”

“By linking our tested GORE DrySeal Flex Introducer Sheath with our endovascular portfolio, we continue to make great strides in advancing patient care,” said Ryan Takeuchi, Gore Aortic Business Leader. “We remain committed to making these innovative devices available to treat more patients globally.”

The GORE DrySeal Flex Introducer Sheath and IBE are available in the U.S., Europe, Canada, and Australia. For more information please visit http://www.goremedical.com/

A virtual brain helps decrypt epilepsy

Researchers at CNRS, INSERM, Aix-Marseille University and AP-HM have just created a virtual brain that can reconstitute the brain of a person affected by epilepsy for the first time. From this work we understand better how the disease works and can also better prepare for surgery.

Worldwide, one percent of the population suffers from epilepsy. The disease affects individuals differently, so personalized diagnosis and treatment are important. Currently we have few ways to understand the pathology’s mechanisms of action, and mainly use visual interpretation of an MRI and electroencephalogram. This is especially difficult because 50% of patients do not present anomalies visible in MRI, so the cause of their epilepsy is unknown.
Researchers have succeeded for the first time in developing a personalized virtual brain, by designing a base “template” and adding individual patient information, such as the specific way the brain’s regions are organized and connected in each individual. Mathematical models that cause cerebral activity can be tested on the virtual brain. In this way, scientists have been able to reproduce the place where epilepsy seizures initiate and how they propagate. This brain therefore has real value in predicting how seizures occur in each patient, which could lead to much more precise diagnosis.

Moreover, 30% of epileptic patients do not respond to drugs, so their only hope remains surgery. This is effective if the surgeon has good indications of where to operate. The virtual brain gives surgeons a virtual “platform.” In this way they can determine where to operate while avoiding invasive procedures, and especially prepare for the operation by testing different surgical possibilities, seeing which would be most effective and what the consequences would be, something that is obviously impossible to do on the patient.
In the long run, the team’s goal is to provide personalized medicine for the brain, by offering virtual, tailored, therapeutic solutions that are specific for each patient. The researchers are currently working on clinical trials to demonstrate the predictive value of their discovery. This technology is also being tested on other pathologies that affect the brain, such as strokes, Alzheimer’s, degenerative neurological diseases, and multiple sclerosis.

A press release can be found on The National Center for Scientific Research (CNRS) website.