Tag: FDA

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Medcrypt Launches Platform to Support Cybersecurity Compliance for Device Manufacturers

The software is intended to help manufacturers demonstrate cybersecurity maturity as expectations from regulators and hospital purchasers continue to rise.

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GE HealthCare Leads FDA AI Device Clearances for Fourth Consecutive Year

The company has now accumulated over 100 authorizations for artificial intelligence in its medical technology portfolio.

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BD Recalls Certain Alaris Pump Infusion Sets Over Accuracy Issues

Use with select infusion sets may lead to over- or under-infusion, bolus inaccuracies, and alarm delays, BD warns in recall notice.

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Medcrypt Launches Platform to Support Cybersecurity Compliance for Device Manufacturers

The software is intended to help manufacturers demonstrate cybersecurity maturity as expectations from regulators and hospital purchasers continue to rise.

HHS, FDA Want to Slash Health Care Rules in 10-to-1 Deregulation Plan

May 13, 2025

The agencies are asking stakeholders to weigh in on a sweeping deregulatory initiative that will eliminate 10 regulations for every one introduced.

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.