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.
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.
Registrar Corp's U.S. FDA News blog provides regulatory updates for FDA regulated industries. Registrar Corp helps medical device establishments comply with FDA regulations, such as registration, listing, UDI and GUDID requirements, 510(k) requirements, and more.
By David Lennarz, Vice President and Co-Founder of Registrar Corp
China looks to double the number of its general doctors by 2020 in a bid to improve healthcare in the People's Republic.
(Reuters) — China will almost double the number of its general doctors by 2020, trim its public sector and improve technology as it seeks to fix a healthcare system plagued by snarling queues and poor rural services, its main administrative authority has said.
Here's a look at some of the top regulatory stories for medical device companies this week: Stryker launches Mako robotic hip replacement; Abiomed soars to new all-time high on FDA nod; FDA grants humanitarian use device status to fetal micro-pacemaker; Wright Medical wins FDA nod for Salvation external fixation device; FDA clears Stryker's Lite lumbar plating system
Vector is Children's Hospital Boston's blog about research and innovation in pediatric and adult medicine. We report and comment on medical innovations and advances – from bench to bedside – touching on scientific, business and policy issues. Our ranks include science writers, physicians, lab researchers, market analysts and others inside and outside the hospital.
Organs-on-chips on display in New York City's Museum of Modern Art. (Photo: Wyss Institute at Harvard University)