TYRX, Inc. has announced that it has received U.S. Food and Drug Administration (FDA) clearance to market the AIGISRx N Antibacterial Envelope for use with vagus nerve stimulators, which are currently used to treat seizure disorders and depression.
The following standard must be met for all medical products intended to be used in the home: IEC 60601-1-11, which is “Medical Electrical Equipment—Part 1-11: General Requirements for Basic Safety and Essential Performance—Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment.”
The FDA today announced the recall of the MedStream Programmable Infusion Pump, an implanted device from Switzerland-based manufacturer Medos Internationalused to treat muscle spasms caused by multiple sclerosis, cerebral palsy, or damage to the brain or spinal cord.
Imagine being able to redirect powerful immune cells to fight cancer. How about reprogramming a diabetic’s skin cell into a cell that could manufacture the insulin their pancreas no longer produces? These are major health problems and medical challenges that may be more achievable with a new fundamental technology that gets vital control molecules into cells faster, safer, and more effectively.
No computer works as efficiently as the human brain – so much so that building an artificial brain is the goal of many scientists. Neuroinformatics researchers from the University of Zurich and ETH Zurich have now made a breakthrough in this direction by understanding how to configure so-called neuromorphic chips to imitate the brain's information processing abilities in real-time.
Digital Angel Corporation, following its recent share exchange with VeriTeQ Acquisition Corporation, announced that VeriTeQ filed a provisional patent with the U.S. Patent and Trademark Office in September 2012 for a microchip that is able to withstand high temperatures in order to make it compatible with the sterilization processes involved in the manufacturing of implantable medical devices.
Multiple sclerosis treatments that repair damage to the brain could be developed thanks to new research. A study has shed light on how cells are able to regenerate protective sheaths around nerve fibres in the brain. These sheaths, made up of a substance called myelin, are critical for the quick transmission of nerve signals, enabling vision, sensation and movement.
MicroVention Announces First Trial Enrollment In Their U.S. Clinical Trial Of Its New Dual-Layer Stent For Cerebral Aneurysm Flow DiversionJuly 22, 2013 10:00 am | by The Associated Press | News | Comments
MicroVention, Inc., a wholly owned subsidiary of Terumo Corporation, announced earlier last week that they successfully completed their first enrollment in a multi-center, prospective, pivotal U.S. clinical trial to demonstrate the safety and efficacy of its FREDT flow diversion system (FREDT-Flow Re-Direction Endoluminal Device) for treating intracranial aneurysms.
Biosan Medical Receives U.S. Patent for Its Novel Device and Method of Treating the Deadliest Type of Stroke, Subarachnoid Hemorrhage (SAH), and Alzheimer’s DiseaseJuly 22, 2013 9:24 am | by Business Wire | News | Comments
Biosan Medical, an emerging medical device company, announced today that it has been issued U.S. Provisional Patent No. 61,957,293 for its revolutionary Ventritek105® Stroke Treatment Device and Method (“Device & method for CSF auto-transfusion therapy for the treatment of SAH (subarachnoid hemorrhage), Alzheimer’s Disease & other Neuro-Degenerative CNS diseases”).
Zynex Signs Strategic Agreement With Advanced Brain Monitoring, Expands Presence in Sleep Diagnostic MarketJuly 22, 2013 8:00 am | by The Associated Press | News | Comments
Zynex, Inc. (OTCQB: ZYXI), a provider and developer of non-invasive medical devices for electrotherapy and stroke rehabilitation, neurological diagnostics and cardiac monitoring, announces that it signed a strategic sales, marketing and distribution agreement with California based Advanced Brain Monitoring.
Massachusetts medical device giant Boston Scientific announced the start of a new clinical trial to evaluate the use of neurostimulation in treatment of chronic migraines. Boston Scientific's OPTIMISE trial is a randomized, placebo-controlled study assessing occipital nerve stimulation as a novel approach to treating migraines by masking the pain.
When someone is diagnosed with depression, patient and doctor often begin a long trial-and-error of different treatments. Sometimes they work, sometimes they don’t, so patients may try several options before finding the best one. But in the future, a brain scan, blood test, or some combination could help guide doctors to the best drugs, or lead them to suggest talk therapy.
University of Arizona researchers have found in a recent study that ultrasound waves applied to specific areas of the brain appear able to alter patients' moods. The discovery has led the scientists to conduct further investigations with the hope that this technique could one day be used to treat conditions such as depression and anxiety.
The metric, called Risk Weighted Cumulative Exposure (RWE), can capture players' exposure to the risk of concussion over the course of a football season by measuring the frequency and magnitude of all impacts, said senior author of the study Joel Stitzel, Ph.D., chair of biomedical engineering at Wake Forest Baptist.
Persons with Alzheimer's disease are able to manage their everyday activities longer and they suffer from less psychological and behavioural symptoms if the diagnosis is made and treatment begun at a very early phase of the disease, indicates a recent study conducted at the University of Eastern Finland.
Memory problems that are often dismissed as a normal part of aging may not be so harmless after all. Noticing you have had a decline beyond the occasional misplaced car keys or forgotten name could be the very earliest sign of Alzheimer's, several research teams are reporting.
A researcher from Imperial College London and his colleagues have developed for the first time a map of a typical bird brain, showing how different regions are connected together to process information.
Device testing is required for a wide array of variables in the development of a medical device. When it comes to devices used directly by the patient, however, it is critical to test the patient/device “relationship.” This article looks at examining and testing the human factor when it comes to the handling of a medical device and how the design can be improved to enhance that relationship.
Edwards Lifesciences wants a federal judge to rule that a pair of patents owned by arch-rival Medtronic are invalid because they aren't specific enough. The patents cover nerve stimulation technology. Edwards and Medtronic have spent considerable time in courts around the world, each arguing that the other's transcatheter aortic valve implant infringes various patents.
NeuroMetrix, Inc., a medical device company focused on the treatment of the neurological complications of diabetes, reported that the SENSUS Pain Management System became the first transcutaneous electrical nerve stimulator to receive 510(k) clearance (K130919) from the U.S. Food and Drug Administration (FDA) for use during sleep.
The U.S. Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. When used as part of a complete medical and psychological examination, the device can help confirm an ADHD diagnosis.
The real time monitoring of brain function has advanced in leaps and bounds in recent years. That’s largely thanks to various new technologies that can monitor the collective behaviour of groups of neurons, such as functional magnetic resonance imaging, magnetoencephalopathy and positron emission tomography.
First experiencing symptoms at just 29-years-old and diagnosed with Parkinson's at age 34, Tommy Zuleger is the youngest patient ever treated at the Muhammad Ali Parkinson Center at Barrow Neurological Institute in Phoenix and he says a new "sci-fi" procedure has given him his life back.
NeuroMetrix's (NSDQ:NURO) Sensus wearable pain management device can now be paired with pajamas thanks to the FDA's clearance of the device for use during sleep. The FDA typically requires warning labels for transcutaneous electrical nerve stimulators like Sensus because of their tendency to dislodge during sleep, which may pose an electrical hazard.
Scientists have created a virtual model of the brain that daydreams like humans do. Researchers created the computer model based on the dynamics of brain cells and the many connections those cells make with their neighbors and with cells in other brain regions.