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.
21st Century Cures, a bipartisan panel led by Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.), calls for the FDA to create a new, expedited review process for medical technology designed to address unmet needs.
A congressional panel is calling fora new, expedited priority review process for medical technology aimed at unmet medical needs, similar to similar programs for drugs and biologics.
Abiomed wins a humanitarian device exemption for its Impella RP
Abiomed (NSDQ:ABMD) today said the FDA approved a humanitarian device exemption for its Impella RP heart pump, calling the device the 1st FDA-approved percutaneous, single-access pump for supporting the heart's right ventricle.
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.
Here's a look at some of the top regulatory stories for medical device companies this week: Medtronic wins HDE for Enterra II neurostim device; FDA officially clears Integra's Puerto Rico plant; Nevro surges on Senza approvable letter from FDA; mHealth: AliveCor wins CE Mark for new afib algorithm; FDA warns against pediatric use of bone growth proteins