The FDA will expand generative AI tools across all centers by June 30 following a successful scientific review pilot, aiming to reduce repetitive tasks and improve operational efficiency.
In a blind review, scans performed by novices using the software met diagnostic standards and matched expert-level quality.
The FDA determined that the company has submitted copied, falsified, or otherwise invalid data in submissions to the agency.
The FDA will expand generative AI tools across all centers by June 30 following a successful scientific review pilot, aiming to reduce repetitive tasks and improve operational efficiency.
Philips’ cardiac telemetry Monitoring Service Application did not route some ECG events from July 2022 to July 2024 for cardiology review.
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The FDA published new draft guidance targeting pulse oximeter accuracy disparities across diverse skin tones.
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The FDA released draft guidance outlining a comprehensive framework for AI-enabled devices throughout their life cycle.
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Baxter is recalling certain Solution Sets with Duo-Vent Spikes due to an assembly issue that led to inverted slide clamps.
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The Inogen Simeox 200 Airway Clearance Device aids bronchial drainage in patients with chronic respiratory conditions using high-frequency oscillatory vibrations and intermittent negative pressure.
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Interlynk’s SBOM Automation Platform helps healthcare organizations manage software risks, maintain transparency, and meet FDA guidelines.
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Movano Health’s EvieMED Ring received FDA 510(k) clearance for its pulse oximeter, enabling expansion into clinical markets.
