INSIGHTEC announced the signing of a strategic agreement with the global leader in Magnetic Resonance Imaging, Siemens Healthineers. The strategic collaboration will involve the development of compatibility between Exablate Neuro and Siemens leading 1.5T and 3T clinical MRI systems, MAGNETOM Aera and Skyra. With this agreement, Siemens Healthineers follows its strategy of broadening and complementing its diagnostic imaging portfolio with advanced therapy solutions. Both parties will work towards providing access to Exablate Neuro for installed base, as well as new product installation customers.
Showing posts with label non-invasive. Show all posts
Showing posts with label non-invasive. Show all posts
16 August, 2016
09 August, 2016
Novel Technology May Prevent Burn Scars
A group of researchers from Tel Aviv University and Harvard University has devised a new non-invasive method to prevent burn scarring caused by the proliferation of collagen cells. They are using short, pulsed electric fields prevent the formation of burn-related hypertrophic scars — raised tissue caused by excessive amounts of collagen.
Research for the study was led by Dr. Alexander Golberg of TAU's Porter School of Environmental Studies, together with Dr. Martin Yarmush of the Center for Engineering in Medicine at Massachusetts General Hospital, Harvard Medical School and Shriners Burns Hospital in Boston. It was recently published in the Journal of Investigative Dermatology.
Ten percent of all unintentional-injury deaths are the result of fire-related burns, according to the World Health Organization. But even for those who survive the destruction of skin and tissue cells, the road to recovery is never ending. Post-burn scarring creates lifelong physical, psychological and social challenges.
Relieving lifelong suffering
"People don't die from scars, but they do suffer from them," said Dr. Golberg. "We believe that the technology we developed, called partial irreversible electroporation (pIRE), can be used to prevent debilitating burn scars from forming."
The non-invasive pIRE technique harnesses microsecond-pulsed, high-voltage, non-thermal electric fields to control the body's natural response to trauma — the proliferation of collagen cells that cause permanent scarring at the site of injury. The technique partially destroys cells in the wound with short, pulsed electric fields that cause irreversible damage to the collagen cells. But the researchers had to find a delicate balance so that the technique didn't create a new wound or "overheal" the existing wound, because scarring is the body's natural way of healing.
The researchers treated burn injuries in rats in five therapy sessions over six months, then assessed them using an imaging technique developed by Drs. Martin Villiger and Brett Bouma's group at the Wellman Center of Photomedicine at Massachusetts General. The researchers found a 57.9% reduction of the scar area in comparison with untreated scars.
Next step: Human clinical studies
"Surgical excision, laser therapy, electron-beam irradiation, mechanical compression dressing, silicone sheet application and other techniques have been tested to treat scars over the years," said Dr. Golberg, "but there have been only modest improvements in the healing outcomes among all these treatments.
"Scarring is a very complex process, involving inflammation and metabolism," said Dr. Golberg. "We have found a way to partially prevent scar formation in animal models. Next we need to raise funding to develop a device for the clinical study on humans."
Research for the study was led by Dr. Alexander Golberg of TAU's Porter School of Environmental Studies, together with Dr. Martin Yarmush of the Center for Engineering in Medicine at Massachusetts General Hospital, Harvard Medical School and Shriners Burns Hospital in Boston. It was recently published in the Journal of Investigative Dermatology.
Ten percent of all unintentional-injury deaths are the result of fire-related burns, according to the World Health Organization. But even for those who survive the destruction of skin and tissue cells, the road to recovery is never ending. Post-burn scarring creates lifelong physical, psychological and social challenges.
Relieving lifelong suffering
"People don't die from scars, but they do suffer from them," said Dr. Golberg. "We believe that the technology we developed, called partial irreversible electroporation (pIRE), can be used to prevent debilitating burn scars from forming."
The non-invasive pIRE technique harnesses microsecond-pulsed, high-voltage, non-thermal electric fields to control the body's natural response to trauma — the proliferation of collagen cells that cause permanent scarring at the site of injury. The technique partially destroys cells in the wound with short, pulsed electric fields that cause irreversible damage to the collagen cells. But the researchers had to find a delicate balance so that the technique didn't create a new wound or "overheal" the existing wound, because scarring is the body's natural way of healing.
The researchers treated burn injuries in rats in five therapy sessions over six months, then assessed them using an imaging technique developed by Drs. Martin Villiger and Brett Bouma's group at the Wellman Center of Photomedicine at Massachusetts General. The researchers found a 57.9% reduction of the scar area in comparison with untreated scars.
Next step: Human clinical studies
"Surgical excision, laser therapy, electron-beam irradiation, mechanical compression dressing, silicone sheet application and other techniques have been tested to treat scars over the years," said Dr. Golberg, "but there have been only modest improvements in the healing outcomes among all these treatments.
"Scarring is a very complex process, involving inflammation and metabolism," said Dr. Golberg. "We have found a way to partially prevent scar formation in animal models. Next we need to raise funding to develop a device for the clinical study on humans."
More information can be found from Tel Aviv University website.
18 July, 2016
Bayer launches TENS device for lower back pain relief
Bayer announced that Aleve® Direct Therapy™, a safe, drug-free, pain relief device, is now available at retailers nationwide in the analgesics aisle. Aleve Direct Therapy uses the same TENS (Transcutaneous Electrical Nerve Stimulation) technology used by doctors to provide consumers with deep penetrating relief at the source of lower back pain. TENS is a non-invasive, drug-free method of controlling pain that works by delivering stimulating pulses at the site of pain.
"For people suffering from lower back pain the availability of the Aleve Direct Therapy TENS Device is good news. The device provides drug-free, deep penetrating lower-back pain relief, without a prescription," said Fred Duchin, Vice President of Marketing Analgesics of Cough & Cold, Cardiovascular, Consumer Health Division.
Aleve Direct Therapy is indicated for the temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. Aleve Direct Therapy is regulated as a Class II medical device and was cleared by the U.S. Food and Drug Administration. Its unique patented waveform technology can provide deep penetrating relief by blocking the body's pain signals and by releasing endorphins in the areas of pain – the two theories behind how TENS technology works.
"Aleve Direct Therapy puts controllable TENS technology in consumers hands without having to visit the doctor. It provides high intensity of power and its wireless remote control makes it easy to adjust the power of intensity to fit the user's needs," said Andre Schmidt, Vice President, US Medical Affairs, Consumer Health Division. "We are pleased to be able to provide this safe, drug-free and convenient self-care option to help consumers get the relief they need from lower back pain."
"For people suffering from lower back pain the availability of the Aleve Direct Therapy TENS Device is good news. The device provides drug-free, deep penetrating lower-back pain relief, without a prescription," said Fred Duchin, Vice President of Marketing Analgesics of Cough & Cold, Cardiovascular, Consumer Health Division.
Aleve Direct Therapy is indicated for the temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. Aleve Direct Therapy is regulated as a Class II medical device and was cleared by the U.S. Food and Drug Administration. Its unique patented waveform technology can provide deep penetrating relief by blocking the body's pain signals and by releasing endorphins in the areas of pain – the two theories behind how TENS technology works.
"Aleve Direct Therapy puts controllable TENS technology in consumers hands without having to visit the doctor. It provides high intensity of power and its wireless remote control makes it easy to adjust the power of intensity to fit the user's needs," said Andre Schmidt, Vice President, US Medical Affairs, Consumer Health Division. "We are pleased to be able to provide this safe, drug-free and convenient self-care option to help consumers get the relief they need from lower back pain."
A press release can be found from Bayer website.
FDA approves exablate neuro system for essential tremor treatment
Insightec announced that the FDA has approved its Exablate Neuro system for the non-invasive treatment of essential tremor (ET) in patients who have not responded to medication.
Exablate Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions or implants. The treatment is done under Magnetic Resonance Imaging (MRI) guidance for real time treatment monitoring. The patient experiences immediate tremor improvement following the outpatient procedure. The treatment carries minimal risk of infection, bleeding or other surgical complications. The treatment requires a single session with no anesthesia, allowing patients to quickly return to normal activity.
Essential tremor is the most common movement disorder, affecting more than 5 million people in the United States, and millions more worldwide. Hand tremor is the most common symptom, but tremors can also affect the head, arms, voice, legs, and torso. For these patients, performing everyday tasks presents a challenge and impacts their quality of life.
This approval by the FDA was based on clinical data from a randomized, double-blind, multi-center clinical study designed to evaluate the safety and efficacy of non-invasive thalamotomy with MRgFUS. A total of 76 patients were enrolled in the study and randomly assigned to receive the Exablate treatment (56 patients) or the sham procedure (20 patients), the exact same procedure but without any ultrasound energy. Patients in the placebo treatment arm were later allowed to undergo an Exablate Neuro treatment. Patients treated with the Exablate Neuro showed nearly a 50% improvement in their tremors and motor function three months after treatment compared to their baseline score. Patients in the control group had no improvement, and some experienced a slight worsening after the sham procedure before they crossed over into the treatment group. A year following the procedure, the patients who underwent the Exablate Neuro procedure retained a 40% improvement in these scores compared to baseline.
“Results of this study show that Exablate Neuro is safe and effective for treating essential tremor. Finding the most effective way to manage tremor symptoms is crucial for patients. The patients we have treated show immediate tremor control, allowing them to regain ability to perform daily tasks such as eating and writing,” commented Dr. W. Jeffrey Elias, Director of Stereotactic and Functional Neurosurgery at the University of Virginia and Principal Investigator in the study.
Earlier this year, Exablate was also approved by Health Canada for essential tremor.
“This newly FDA approved device provides a new treatment option without some of the complications associated with surgery to offer patients with essential tremor. Furthermore, it holds promise for a range of neurosurgical procedures,” noted Andres Lozano, MD, Dan Family Professor and Chairman of Neurosurgery at Toronto Western Hospital, University of Toronto and Investigator in the study.
“I am confident that we have arrived at a tipping point for non-invasive medical treatment. Focused ultrasound has the unique ability to precisely ablate target tissue deep within the body. With Exablate Neuro, INSIGHTEC expands its Exablate product line with a system that signifies a new era for functional neurosurgery,” stated Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board.
Exablate Neuro also has CE mark for essential tremor, tremor dominant Parkinson’s disease and neuropathic pain.
Exablate Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions or implants. The treatment is done under Magnetic Resonance Imaging (MRI) guidance for real time treatment monitoring. The patient experiences immediate tremor improvement following the outpatient procedure. The treatment carries minimal risk of infection, bleeding or other surgical complications. The treatment requires a single session with no anesthesia, allowing patients to quickly return to normal activity.
Essential tremor is the most common movement disorder, affecting more than 5 million people in the United States, and millions more worldwide. Hand tremor is the most common symptom, but tremors can also affect the head, arms, voice, legs, and torso. For these patients, performing everyday tasks presents a challenge and impacts their quality of life.
This approval by the FDA was based on clinical data from a randomized, double-blind, multi-center clinical study designed to evaluate the safety and efficacy of non-invasive thalamotomy with MRgFUS. A total of 76 patients were enrolled in the study and randomly assigned to receive the Exablate treatment (56 patients) or the sham procedure (20 patients), the exact same procedure but without any ultrasound energy. Patients in the placebo treatment arm were later allowed to undergo an Exablate Neuro treatment. Patients treated with the Exablate Neuro showed nearly a 50% improvement in their tremors and motor function three months after treatment compared to their baseline score. Patients in the control group had no improvement, and some experienced a slight worsening after the sham procedure before they crossed over into the treatment group. A year following the procedure, the patients who underwent the Exablate Neuro procedure retained a 40% improvement in these scores compared to baseline.
“Results of this study show that Exablate Neuro is safe and effective for treating essential tremor. Finding the most effective way to manage tremor symptoms is crucial for patients. The patients we have treated show immediate tremor control, allowing them to regain ability to perform daily tasks such as eating and writing,” commented Dr. W. Jeffrey Elias, Director of Stereotactic and Functional Neurosurgery at the University of Virginia and Principal Investigator in the study.
Earlier this year, Exablate was also approved by Health Canada for essential tremor.
“This newly FDA approved device provides a new treatment option without some of the complications associated with surgery to offer patients with essential tremor. Furthermore, it holds promise for a range of neurosurgical procedures,” noted Andres Lozano, MD, Dan Family Professor and Chairman of Neurosurgery at Toronto Western Hospital, University of Toronto and Investigator in the study.
“I am confident that we have arrived at a tipping point for non-invasive medical treatment. Focused ultrasound has the unique ability to precisely ablate target tissue deep within the body. With Exablate Neuro, INSIGHTEC expands its Exablate product line with a system that signifies a new era for functional neurosurgery,” stated Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board.
Exablate Neuro also has CE mark for essential tremor, tremor dominant Parkinson’s disease and neuropathic pain.
A press release can be found from Insightec website.
13 May, 2016
Device to release cancer cells for better analysis
A new device developed at the University of Michigan could provide a non-invasive way to monitor the progress of an advanced cancer treatment.
It can pick cancer cells out of a blood sample and let them go later, enabling further tests that can show whether the therapy is successfully ridding the patient of the most dangerous cancer cells.
Cells released into the bloodstream by tumors could be used to monitor cancer treatment, but they are very difficult to capture, accounting for roughly one in a billion cells, says Sunitha Nagrath, U-M assistant professor of chemical engineering.
Nagrath and her collaborators pioneered technologies for capturing these cells from blood samples. Their devices trapped the cells on chips made with graphene oxide, a single layer of carbon and oxygen atoms. But all analysis had to be done on the chip because the cells were firmly stuck.
"We could grow the cells on the chip or analyze them all together, but research has shown that cancer cells are not all the same," she said. "Hence, it is important to study cells individually, and our new device makes this possible."
The stem cell theory of cancer holds that relapses occur because chemotherapy and radiation therapy are not very effective at killing cancer stem cells, which can make up as much as 10 percent of a tumor. As a result, the cancer stem cells left behind are able to regrow the tumor or spread to other areas of the body.
New treatments in clinical trials attack the stem cells, but killing this smaller population does not immediately shrink the tumor. Doctors need a good way to monitor whether the cancer stem cells are on the decline. This may be possible through blood tests, but clinicians need to study captured cells individually, and that means removing them from the chip.
A press release can be found from University of Michigan website.
It can pick cancer cells out of a blood sample and let them go later, enabling further tests that can show whether the therapy is successfully ridding the patient of the most dangerous cancer cells.
Cells released into the bloodstream by tumors could be used to monitor cancer treatment, but they are very difficult to capture, accounting for roughly one in a billion cells, says Sunitha Nagrath, U-M assistant professor of chemical engineering.
Nagrath and her collaborators pioneered technologies for capturing these cells from blood samples. Their devices trapped the cells on chips made with graphene oxide, a single layer of carbon and oxygen atoms. But all analysis had to be done on the chip because the cells were firmly stuck.
"We could grow the cells on the chip or analyze them all together, but research has shown that cancer cells are not all the same," she said. "Hence, it is important to study cells individually, and our new device makes this possible."
The stem cell theory of cancer holds that relapses occur because chemotherapy and radiation therapy are not very effective at killing cancer stem cells, which can make up as much as 10 percent of a tumor. As a result, the cancer stem cells left behind are able to regrow the tumor or spread to other areas of the body.
New treatments in clinical trials attack the stem cells, but killing this smaller population does not immediately shrink the tumor. Doctors need a good way to monitor whether the cancer stem cells are on the decline. This may be possible through blood tests, but clinicians need to study captured cells individually, and that means removing them from the chip.
10 May, 2016
Non-invasive microwave device to monitor diabetes
A team of researchers from the School of Engineering at Cardiff University in Wales, UK have developed a wearable glucose monitor that does not require the extraction of blood.
Instead of taking measurements by pricking the skin, the device, which attaches to the body via sticky adhesives, uses microwaves to measure glucose levels, sending the resulting data to a computer or mobile app.
The team, led by Professor Adrian Porch and Dr Heungjae Choi, believe the device could make life easier for the millions of people suffering from diabetes around the world and, with the right investment, could reach the market within five years.
The project has received £1m in funding from the Wellcome Trust up to now, and has already been used in clinical trials in patients.
Instead of taking measurements by pricking the skin, the device, which attaches to the body via sticky adhesives, uses microwaves to measure glucose levels, sending the resulting data to a computer or mobile app.
The team, led by Professor Adrian Porch and Dr Heungjae Choi, believe the device could make life easier for the millions of people suffering from diabetes around the world and, with the right investment, could reach the market within five years.
The project has received £1m in funding from the Wellcome Trust up to now, and has already been used in clinical trials in patients.
More information can be found by clicking this link.
22 April, 2016
Brain stimulation may reduce anorexia symptoms
Core symptoms of anorexia nervosa, including the urge to restrict food intake and feeling fat, are reduced after just one session of a non-invasive brain stimulation technique, according to King’s College London Research.
This new study is the first randomised control trial to assess whether repetitive transcranial stimulation (rTMS), already an approved treatment for depression, is also effective in reducing symptoms of anorexia.
Up to 20 per cent of people with anorexia die prematurely from the disorder and treatments in adults are moderately effective, with only 20-30 per cent of people recovering from the best available talking therapies.
Given the urgent need to improve treatments, researchers are increasingly looking towards emerging neuroscience-based technologies that could target the underlying neural basis of anorexia.
In the study, 49 people completed food exposure and decision-making tasks, both before and after a session of either real or placebo rTMS. Symptoms of anorexia were measured immediately prior to and following rTMS, as well as 20 minutes and 24 hours after the session.
This new study is the first randomised control trial to assess whether repetitive transcranial stimulation (rTMS), already an approved treatment for depression, is also effective in reducing symptoms of anorexia.
Up to 20 per cent of people with anorexia die prematurely from the disorder and treatments in adults are moderately effective, with only 20-30 per cent of people recovering from the best available talking therapies.
Given the urgent need to improve treatments, researchers are increasingly looking towards emerging neuroscience-based technologies that could target the underlying neural basis of anorexia.
In the study, 49 people completed food exposure and decision-making tasks, both before and after a session of either real or placebo rTMS. Symptoms of anorexia were measured immediately prior to and following rTMS, as well as 20 minutes and 24 hours after the session.
This study represents independent research part-funded by the National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at South London and Maudsley NHS Foundation Trust and King’s College London.
For more details please visit King's College London Research website by clicking here.
12 April, 2016
CFDA approves 2 non-invasive fingertip mounted device from CNOGA
CNOGA Medical has received China CFDA approval for two of their non-invasive fingertip devices for detection of bio-parameters.
One product is named as the MTX, a novel Non-Invasive Fingertip mounted device designed to measure a wide range of physiological bio-parameters without the need to take painful invasive blood samples.
Based on tissue photography analysis of the fingertip capillaries, a single MTX device can analyze more than 14 different bio parameters within seconds. Combining the MTX with Cnoga’s mobile application and cloud-based services provides health care professionals and organizations with an easy access to medical data for better disease management thus enabling true ongoing remote monitoring.
The other product is the so called VSM cuff-less, simple to use, portable device which can measure blood pressure, pulse, blood Oxygen saturation and also fits into your pocket. Cnoga’s unique technology enables continuous blood pressure measurements without the need of using an arm cuff and air pressure.
Based on tissue photography analysis of the fingertip capillaries, a single MTX device can analyze more than 14 different bio parameters within seconds. Combining the MTX with Cnoga’s mobile application and cloud-based services provides health care professionals and organizations with an easy access to medical data for better disease management thus enabling true ongoing remote monitoring.
The other product is the so called VSM cuff-less, simple to use, portable device which can measure blood pressure, pulse, blood Oxygen saturation and also fits into your pocket. Cnoga’s unique technology enables continuous blood pressure measurements without the need of using an arm cuff and air pressure.
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