Medical device manufacturers filing Investigational Device Exemption (IDE) submissions for clinical investigation approval will soon find a more efficient and updated application process, according to the US Food and Drug Administration.
Is marijuana bad, or could it be good for some? CNN chief medical correspondent Dr. Sanjay Gupta spent a year traveling around the world to shed light on the debate.
India, Mexico, China, Africa, and Mideast countries represent fastest growth markets, according to new Freedonia study.
Researchers at Harvard University have created the first noninvasive brain-to-brain interface (BBI) between a human… and a rat. Simply by thinking the appropriate thought, the BBI allows the human to control the rat’s tail. This is one of the most important steps towards BBIs that allow for telepathic links between two or more humans — which is a good thing in the case of friends and family, but terrifying if you stop to think about the nefarious possibilities of a fascist dictatorship with mind control tech.
An ongoing collaboration between the Japanese Riken Brain Science Institute and MIT’s Picower Institute for Learning and Memory has resulted in the discovery of how to plant specific false memories into the brains of mice. The breakthrough significantly extends our understanding of memory and expands the experimental reach of the new field of optogenetics.
The FDA wants a new subcommittee of its Science Board to suggest ways to improve regulatory science at the Center for Devices & Radiological Health. The FDA’s Science Board yesterday agreed to form a new subcommittee to help the agency examine 3 specified domains of regulatory science activities related to medical devices, assess progress made since 2007, and address the challenges posed by rapidly evolving science and technology.
Medical device industry lobbying group AdvaMed urges the FDA to avoid making needless changes to the 510(k) medical device review pathway, particularly to the rules for when device modifications merit a new application.
Researchers have tested an artificial pancreas that could one day improve lives of millions of people suffering from diabetes in a home environment for the first time.
Researchers explore new diabetes test: University of Pittsburgh chemists have demonstrated a sensor technology that could significantly simplify the diagnosis and monitoring of diabetes through breath analysis.
For Gary Walters, the entrepreneurial brainstorm came while mowing his lawn on a hot San Antonio day. An Iraq war veteran, Walters lost his right leg below the knee in a bomb blast eight years ago, and he has suffered from excessive heat and sweating where his prosthesis is joined to his leg, a common problem for amputees. “It gets close to 100 degrees in there,” he says. “It’s just like having your hand under water all day. Your skin starts to break down, you get friction blisters, heat rash, open sores.”