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.
FDA's official blog brought to you from FDA's senior leadership and staff stationed at home and abroad – sharing news, background, announcements and other information about the work done at the FDA on behalf of the American public.
Kathryn O’Callaghan, Associate Director for Science and Strategic Partnerships (Acting), FDA's Center for Devices and Radiological Health
By Kathryn O’Callaghan and Jeffrey Shuren, M.D., J.D.
The world was a very different place in 1976, when the Food and Drug Administration launched its medical device program.
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.
Obama administration proposes a plan to move most doctors, hospitals and their patients to national standards for handling electronic clinical data by the end of 2017.
(Reuters) - The Obama administration on Friday proposed a plan to move most doctors, hospitals and their patients to national standards for handling electronic clinical data by the end of 2017.
The U.S. Department of Health and Human Services (HHS), as part of an effort to propel the $2.9 trillion U.S. healthcare system away from a costly fee-for-service system, released a report draft aimed at establishing an inter operable health information technology system that can be accessed by patients and their healthcare providers.
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.
South Korean medical device regulators will implement significant changes affecting compliance requirements for in vitro diagnostic (IVD) registration as well as for Korean Good Manufacturing Practice (KGMP) audits over the course of 2015.