DUBLIN--(BUSINESS WIRE)--The "Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations" conference has been added to ResearchAndMarkets.com's offering. This intensive four-day ...
Neuralink, Elon Musk’s frothy brain-computer interface company, poached David McMullen, director of FDA’s office of ...
In 2023, the Food and Drug Administration (FDA) took a more active approach to medical device cybersecurity. They issued new requirements for premarket submission and ongoing monitoring by medical ...
To support the continued development and marketing of safe and effective medical devices enhanced by artificial intelligence, the U.S. Food and Drug Administration will offer marketing submission ...
Artificial intelligence (AI) is no longer the future of healthcare—it’s already here. AI-driven medical devices are diagnosing diseases faster than doctors, guiding surgical procedures with precision ...
FDA's challenges — such as insufficient staffing — can create inefficiencies in the process and potentially put lives at risk ...
On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...
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