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FDA Seeks Public Comment on Real-World AI Medical Device Performance

The agency is requesting public comment on methods for monitoring and evaluating AI models after deployment to ensure continued safety and effectiveness.

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FDA Flags Defibrillator Lead Issue Linked to Serious Injuries, Deaths

Boston Scientific’s Endotak Reliance leads with ePTFE-coated coils may reduce shock efficacy due to coil calcification.

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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 Seeks Public Comment on Real-World AI Medical Device Performance

The agency is requesting public comment on methods for monitoring and evaluating AI models after deployment to ensure continued safety and effectiveness.

FDA Plans Agency-Wide AI Rollout Following Scientific Review Pilot

May 8, 2025

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.

FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities

May 7, 2025

The FDA is ramping up unannounced inspections at foreign sites producing medical products and other goods to align regulatory oversight with domestic standards.

Tariffs Create Ripple Effects Across Medical Device Regulatory Pathways

May 6, 2025

Changes in suppliers and manufacturing locations to avoid tariffs can require new regulatory filings, increasing time and cost burdens across global markets.