The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is expanding a new pilot program that it hopes will make medical device submissions a lot less complicated and a lot more like filing taxes using TurboTax.
Researchers are developing an implantable sensor for glaucoma that allows intraocular pressure to be read by a smartphone camera. Diagnosis and monitoring now relies on a trip to the ophthalmologist and a reading of intraocular pressure that can vary widely. The implant/smartphone combination is expected to allow at-home monitoring and a series of readings that could improve diagnosis and monitoring of glaucoma patients.
Sciientists have linked a single enzyme to the development of diabetes, a finding that could help develop new treatments for the more than 120 million Americans that have diabetes or pre-diabetes.
Bees give us honey, painful stings…and cancer-fighting drugs, if scientists can figure out how to extract and deliver the venom’s cancer-fighting compounds. University of Illinois Bioengineering Professor Dipanjan Pan says he has developed nanoparticles that can carry insect toxins directly to tumors, sparing the rest of the body from nasty side effects, including damage to the heart, bleeding underneath the skin and unwanted clotting.
The US Food and Drug Administration (FDA) approved new medical device products at a pace nearly twice that of the year prior, according to a new report just published by analysts at EP Vantage, the market intelligence branch of Evaluate.
A biopsy is the only sure way to diagnose skin cancer; however, having good confidence that a lesion is cancerous before a biopsy can reduce the number of unnecessary biopsies performed. A new tool developed by researchers at University of Texas at Austin uses three different mechanisms to image a lesion, potentially providing a new way to identify suspected tumors. It is currently undergoing pilot clinical trials.
Several companies are developing wearable biosensors in the form of wristbands; however, the co-founder of biosensing technology company Valencell says the ear is the best to place collect vital signs, and giants Intel and Apple have earbud ambitions as well.
One of the authors of a controversial and now-retracted paper purporting a stem cell breakthrough has been found dead in what appears to be a suicide, according to numerous reports, following an investigation that has alarmed researchers and rattled one of Japan’s most respected institutions.
List is for products that are ‘understood’ and do not present ‘risks’; The FDA released a list of 107 medical devices it will exempt from its 510(k) Premarket Notification Regulations as part of the agency’s efforts to streamline its approval process for products similar to those that have already undergone testing and trials.
Regulatory functions at the U.S. Food and Drug Administration (FDA) were set to undergo a major overhaul in the later months of 2014 after a year-long effort by the Agency recommended making scores of improvements to the way the agency is structured and regulates products.Regulatory functions at the U.S. Food and Drug Administration (FDA) were set to undergo a major overhaul in the later months of 2014 after a year-long effort by the Agency recommended making scores of improvements to the way the agency is structured and regulates products.