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FDA Grants Breakthrough Status to SonoClear for Intracranial Ultrasound

Designed to reduce imaging artifacts during neurosurgery, the SonoClear System now has FDA Breakthrough Device status and is moving toward 510(k) submission.

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FDA Plans Agency-Wide AI Rollout Following Scientific Review Pilot

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.

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FDA Clears AI Software Validated to Guide Novices in Cardiac Imaging

In a blind review, scans performed by novices using the software met diagnostic standards and matched expert-level quality.

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FDA Grants Breakthrough Status to SonoClear for Intracranial Ultrasound

Designed to reduce imaging artifacts during neurosurgery, the SonoClear System now has FDA Breakthrough Device status and is moving toward 510(k) submission.

FDA Flags Medical Device Testing Firm for Submitting Falsified or Copied Data

Mar 11, 2025

The FDA determined that the company has submitted copied, falsified, or otherwise invalid data in submissions to the agency.

FDA Issues Early Alert on Baxter Spectrum Infusion Pump Recall

Mar 5, 2025

The FDA has issued an early alert regarding Baxter’s recall of certain Spectrum infusion pumps due to missing motor mounting screws, which may have occurred during servicing.

Does This Patient Monitor Contain a Chinese Backdoor? Experts Say the Risk Is Real—But Different

Feb 12, 2025

While cybersecurity alerts raised concerns about a potential backdoor linked to a Chinese IP address, researchers uncovered a different—but still serious—security risk.