Cognoa's autism detection application has been recognized by FDA as a Class II diagnostic medical device and paves the way for the company to get full clearance under the de novo pathway.
News & Features
John McDermott will be stepping down as CEO of the struggling EVAR company as soon as the board hires his replacement.
Think your startup has what it takes to go head to head with other young companies in medtech? Find out by entering our annual tournament.
Boston Sci is looking at $1M in fines from Italian court in relation to one of its employees financing unauthorized clinical trials.
Medical device professionals can take advantage of a host of free educational opportunities at the Advanced Design & Manufacturing Cleveland event on March 7 and 8.
The company is delaying the release of its 2017 financial results due to an internal investigation surrounding its sales and distribution practices.
After scraping a stock offering last month to investigate a whistleblower complaint, the weight-loss balloon company said the allegations were found to have no merit.
Researchers have developed a potential alternative to the polypropylene vaginal mesh implants that have caused complications for millions of women.
With Johnson & Johnson's acquisition of Orthotaxy, it joins a growing list of medtech players seeking to beef up their offerings in the surgical robotics market.
Banyan Biomarkers is one of the first companies to bring a blood-based test to aid in the detection of traumatic brain injuries and concussions to the U.S. market.
The way FDA analyzes recalls and applies its list of root-cause possibilities needs a dose of transparency.