Five years after promising to fix a flawed regulatory pathway widely used by medical device manufacturers, the Food and Drug Administration has issued new guidelines to improve its so-called 510(k) ...
The Biden administration is considering creating a quicker process to review new medical devices for Medicare coverage after a controversial Trump-era rule was scrapped. Officials with the Centers for ...
The American Telemedicine Association, the College of Healthcare Information Management Executives (CHIME) and Otsuka America Pharmaceutical are among the groups in support of the Centers for Medicare ...
WASHINGTON -- Roughly 3,000 medical devices enter the U.S. market every year through a system generally requiring little or no patient testing to verify safety and effectiveness. Unlike new ...
Yesterday, the FDA announced in a press release that it is eyeing potential updates to the agency’s 510(k) clearance pathway for medical devices. These could include a requirement for more modern ...
As Medical Devices have continued to innovate, embedded software has grown. Software, artificial intelligence (AI), and machine learning (ML) are now a part of nearly every medical device. These ...
BERWYN, Pa.--(BUSINESS WIRE)--Virpax ® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing non-addictive products for pain management, post-traumatic ...
An accelerated regulatory pathway in Mexico has positioned the country as a priority launch market for medical devices. Guerreschi: This pathway is designed to reduce approval timelines by the Federal ...
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