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.
Medical Device Business
John McDermott will be stepping down as CEO of the struggling EVAR company as soon as the board hires his replacement.
Boston Sci is looking at $1M in fines from Italian court in relation to one of its employees financing unauthorized clinical trials.
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.
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.
Becton Dickinson is suing competitor Cytek, claiming that the company stole information after hiring several former BD employees.
Edwards picks up a CE mark for the Centera valve in a move that could strengthen its position in the growing TAVR market.
Here's a look at the companies that broke into the ranks of the top 100 medical device and diagnostics companies last year.
LivaNova said it will pay up to $250 million for TandemLife, a deal that will significantly bolster its cardiac surgery portfolio.
Pricing headwinds under the Medtronic agreement is expected to slow Mazor's growth in 2018, but longer-term prospects are promising.
FDA's recent approval of stroke detection software paves the way for Artificial Intelligence applications to thrive on the healthcare landscape.