Study reveals a gap FDA approval AI radiology devices with only 29% undergoing clinical testing before clearance.
Beyond Tariffs: The Software Supply Chain Risks Every Medical Device Manufacturer Should Be Watching
By reframing security as an investment rather than a cost, MDMs can reduce risk exposure, improve compliance readiness, and ...
Rhythio Medical’s soft, conductive hydrogel technology transforms traditional defibrillation into a new class of injectable bioelectronic therapy Rhythio Medical, a medical device company pioneering ...
WASHINGTON — Days after expanding a 2024 health alert about high levels of lead in ground cinnamon, the FDA has added new products to the advisory and is warning customers not to consume even more ...
The U.S. Food and Drug Administration (FDA) recently announced a Request for Public Comment on the evaluation of devices that integrate artificial intelligence (AI), including generative AI ...
The FDA’s call for feedback is informed by evidence that the performance of AI-enabled medical devices can change over time. As the agency explained in its request for comment, factors such as changes ...
YONGIN, South Korea, Sept. 23, 2025 /PRNewswire/ -- Noul Co., Ltd. (CEO: David Lim), a medical AI company specializing in blood and cancer diagnostics, announced that FDA registration has been ...
The latest recall on shrimp sold at Kroger comes on the heels of another recall that affected 150,000 pounds of shrimp sold at Kroger stores. The recalled shrimp and shrimp cocktail products ...
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