Examining The FDA's Recommendations For AI-Enabled Medical Devices
The FDA stated that its published medical device cybersecurity requirements from 2023 do include AI in a broad sense. However ...
FDA moves to rehire medical device staffers fired only days earlier
The reversal is the latest example of President Donald Trump and billionaire Elon Musk's chaotic approach to cost-cutting, ...
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 ...
Oops! Trump Accidentally Fired FDA Medical Device Reviewers
The Food and Drug Administration is scrambling to bring back hundreds of critical workers laid off en masse by DOGE.
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Medical device recalls hit a four-year high in 2024. Here’s why
Medical device recalls surged last year, driven by stricter FDA oversight and a big jump in the most serious type of recalls.
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AdvaMed's 2025 agenda outlines tariff, AI, device recall asks
AdvaMed is urging Congress to address tariffs, streamline medtech coverage, update AI policies and improve FDA hiring.
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FDA brings back some fired device staff
An industry source said “most, if not all” of the people at the CDRH who were recently dismissed are now being asked to ...