Nearly a third of FDA medical device adverse events reported late: study

Nearly a third of medical device adverse events were not submitted to the FDA within a 30-day regulatory window, with most ...
Fierce Healthcare

FDA introduces TEMPO model as companion to CMS ACCESS model for uncleared devices

The Food and Drug Administration plans to select about 40 devices not yet cleared by the agency to receive special agency discretion to participate in the new chronic care Advancing Chronic Care with ...
NBC News

FDA rehires staff to its medical devices division after mass layoffs

The Trump administration is reinstating some employees in the Food and Drug Administration's medical devices division after dozens were laid off as part of a government-wide cost-cutting initiative ...
BGR

Apple Watch Hypertension Notifications Are Coming Next Week, As FDA Approves The New Health Feature

Apple unveiled three new Apple Watch models during the iPhone 17 event on Tuesday, including the Apple Watch Series 11, Apple Watch Ultra 3, and Apple Watch SE 3. Along with the new hardware, the ...
Seeking Alpha

FDA issues first draft guidance on use of AI in drug, medical device development

Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released separate draft guidance on the use of the technology in the development of ...