In 2005’s “ Why Software Fails ,” in IEEE Spectrum, a seminal article documenting the causes behind large-scale software ...
December 1, 2025Sara Brenner, M.D., MPHPrincipal Deputy CommissionerU.S. Food and Drug Administration10903 New Hampshire Ave.Silver Spring, MD 20993Submitted ElectronicallyRE: FDA-2025-N-4203 Request ...
Medical Device Network on MSNOpinion
UK reforms highlight the case for digital submissions in medical device regulation
Diogo Geraldes, director of regulatory strategy, Europe at Veeva MedTech, discusses the potential of digital submissions to ...
Akura Medical, a Shifamed portfolio company, announced today that it completed the first close of its Series C financing, raising $53 million.
Imricor has completed the world’s first ischemic ventricular tachycardia ablation procedure under MRI. CEO Steve Wedan has ...
"What's next for smart implants in health care?" details how advanced medical devices, embedded with sensors and data ...
The AHA provided recommendations to the Food and Drug Administration today in response to a request for information on the measurement and evaluation of artificial intelligence-enabled medical devices ...
AdvaMed supported changes made from a draft version but still has concerns about the impact on patient access.
Artificial Intelligence (AI) is increasingly transforming healthcare. Hospitals and health systems are exploring AI to ...
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