Researchers who monitored people with deep brain stimulation implants for 8 years suggest that the treatment can benefit those with severe depression. Regulators in the United States have already approved deep brain stimulation for the treatment of Parkinson’s disease, epilepsy, essential tremor, and obsessive-compulsive disorder. The treatment involves implanting wires into the brain and a stimulator in the chest …
Medtronic (NYSE:MDT) said today that it won FDA approval for a clinical trial of its Infuse bone graft in transforaminal lumbar interbody fusion spine procedures. The Minneapolis-based company started recruiting for the prospective, randomized pivotal trial, which is slated to enroll up to 1,000 patients. The TLIF trial would be the second clinical trial for Infuse, …
The New York Times last Friday released an editorial calling for improved regulation on medical devices from the FDA, citing a number of recent controversial devices that have made headlines for injuries and deaths related to their use. If you want to read more about this news click here.
«The Food and Drug Administration (FDA, Agency) identified a list of class I devices and class II devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA published the lists of final determinations in accordance with procedures established by the 21stCentury Cures Act (Cures Act). Although each classification regulation for each …
