When it comes to regulating medical devices, the status quo of relying on premarket evidence has its limitations: it’s expensive, it’s time-consuming, and it isn’t necessarily the best data to show ...
The FDA's Center for Devices and Radiological Health has been busy over the last couple of months, releasing several draft and final guidances that affect the makers of apps and connected devices.
WASHINGTON, Feb 23 (Reuters) - The U.S. Food and Drug Administration proposed on Monday a new framework to speed approvals of ...
NRx together with Osmind, Inc. conducted an in-person meeting attended by leadership of the FDA Division of Psychiatry ...
LEWES, Del., Jan. 21, 2026 (GLOBE NEWSWIRE) -- John Snow Labs, a healthcare AI company, today announced that its Patient Journey Intelligence (PJI) platform is the first secondary-use data platform ...
Drug sponsors should nevertheless bolster their application with “confirmative evidence,” chief regulators Marty Makary and Vinay Prasad said on Wednesday, including mechanistic data or findings from ...
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 ...
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