FDA Launches Digital Health Pilot for Chronic Disease Technologies
The pilot will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use in chronic conditions.
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FDA Warns of Injuries and Deaths Linked to Hyperbaric Oxygen Therapy
The agency reminds healthcare facilities to follow manufacturer instructions for use and maintenance after reports of fires, serious injuries, and deaths.
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BD Recalls Alaris Pump Modules Serviced With Previously Recalled Parts
The voluntary recall involves pump modules that may have been repaired with FR-110 bezels, which the company says can weaken over time and compromise safe infusion delivery.
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FDA Launches Digital Health Pilot for Chronic Disease Technologies
The pilot will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use in chronic conditions.
FDA Authorizes AI Platform for Breast Cancer Prediction
The FDA grants De Novo authorization for a new device for future five-year breast cancer risk prediction, based on an image alone.
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HHS, FDA Want to Slash Health Care Rules in 10-to-1 Deregulation Plan
The agencies are asking stakeholders to weigh in on a sweeping deregulatory initiative that will eliminate 10 regulations for every one introduced.
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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 Expands Unannounced Inspections at Foreign Manufacturing Facilities
The FDA is ramping up unannounced inspections at foreign sites producing medical products and other goods to align regulatory oversight with domestic standards.
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Tariffs Create Ripple Effects Across Medical Device Regulatory Pathways
Changes in suppliers and manufacturing locations to avoid tariffs can require new regulatory filings, increasing time and cost burdens across global markets.
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Opinion: Right to Repair Must Stop Where Patient Safety StartsÂ
A former FDA official argues that medical device repair needs stricter oversight to protect patient safety amid growing right to repair efforts.
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FDA Warns ICU Medical Over Infusion Pump Modifications
The FDA has issued a warning letter to ICU Medical, citing regulatory violations related to unapproved modifications to two of its infusion pumps.
