FDA Issues Warning Letter to Zoll Medical Over Quality System Violations
The agency cites failures in corrective actions, design validation, and reporting for ventilators, defibrillators, and sensors.
Tag: FDA
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Philips Receives FDA Clearance for Rembra CT Platform
Clearances for Rembra CT, Rembra RT, and Areta RT aim to enable high-throughput imaging at scale and elevate precision across the cancer care pathway.
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Why the Service Manual is the Master Key to the HTM Device Lifecycle
Service manuals aren’t optional or proprietary “extras” in a hospital. They’re required for safe maintenance and compliance, and they should be non-negotiable at purchase.
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FDA Issues Warning Letter to Zoll Medical Over Quality System Violations
The agency cites failures in corrective actions, design validation, and reporting for ventilators, defibrillators, and sensors.
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 Expands Early Alert Program for High-Risk Device Issues
The initiative provides faster notifications on potentially high-risk removals or corrections for all medical devices.
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Class I Recall Expanded for Alaris Pump Infusion Sets
The voluntary recall involves certain infusion sets used with the BD Alaris Pump Module model 8100 due to performance deviations that could impact dose accuracy.
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FDA CDRH Leaders to Speak at Town Hall at the 2025 MedTech Conference
The session will provide an update on the center’s strategic direction and priorities and include a question-and-answer period for attendees.
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Medical Device Recalls Hit 20-Year High as FDA Implements AI-Driven Review Process
New Sedgwick report shows Q2 2025 saw highest quarterly Class I medical device recalls in two decades, while agency launches generative AI tool for faster approvals.
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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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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.
