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.
There was a significant amount of turnover this year in the corner offices of medical device companies, including exits by some of medtech's biggest names.
There was a revolving door on medtech's corner office this year, with more than 35 CEOs leaving their positions through planned transitions, retirement or termination, according to a MassDevice.com analysis.
Here's a look at some of the top legal news stories for medical device companies this week: Lawyer says Guidant didn't breach deal with J&J; Ex-Abbott stent liaison alleges retaliation for compliance complaint; Trial date set for Boston Scientific executive's accused killer; Analogic expects fines in BK Medical's Danish bribery beef; SEC dings Bruker in $2.4m China bribery case
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.