The FDA grants de novo clearance to HeartFlow's novel system for non-invasive measurement of fractional flow reserve, which CEO Dr. John Stevens calls "the gold standard" for diagnosing and treating coronary disease.
The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.
A new law implemented in Canada, the Protecting Canadians from Unsafe Drugs Act, has expanded Health Canada's oversight of the country's medical device market in an effort to bring Canadian patient safety requirements more in line with international standards.
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com's coverage highlights our 3 biggest and most influential stories from the day's news to make sure you're up to date on the headlines that continue to shape the medical device industry.
The Centers for Medicare & Medicaid Services will officially remove national coverage decisions for 7 procedures under a program initiated in November 2013, including stereotactic cingulotomy, tinnitus masking and more.
The Centers for Medicare & Medicaid Services are removing national coverage decisions for 7 medical procedures, including certain types of lobotomies and tinnitus masking devices, after a year-long review initiated in November 2013.