FDA Clears Sentec’s LuMon System for Bedside Lung Imaging
The LuMon system provides real-time, radiation-free lung imaging for premature infants, children, and adults, helping clinicians tailor respiratory therapy at the bedside.
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FDA Clears CT-Based Ventilation-Perfusion Software
The solution converts standard non-contrast chest CTs into quantitative lung function maps and has also received CMS reimbursement confirmation.
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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 Clears GE HealthCare CT System for Cardiac Imaging
The system uses AI-powered tools to speed up workflows and is designed to handle complex cardiac cases.
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FDA Announces Class I Recall for ICU Medical Infusion Pump
A software flaw that may cause the Plum Duo Infusion System to become unresponsive has prompted a device correction, which the FDA has identified as its most serious recall type.
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