FDA Clears 3D Imaging Platform for Existing Surgical C-Arms
The CBeam system enables 3D visualization using existing hospital infrastructure during orthopedic and neurological procedures.
Category: FDA Updates
FDA Updates
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FDA Updates
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FDA Clears New Contrast Management System for Cardiovascular Procedures
The ACIST Pro Diagnostic System provides automated contrast delivery to improve efficiency and safety in cardiac catheterization labs.
FDA Updates
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FDA Clears Abbott’s AI-Powered Coronary Imaging Software
The Ultreon 3.0 software uses optical coherence tomography and artificial intelligence to guide physicians during procedures to open blocked arteries.
Clearances
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FDA Clears New Device for Transseptal Heart Access
The system is designed to improve workflow efficiency and safety during minimally invasive left-heart procedures.
Recalls
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Fresenius Kabi Issues Critical Software Update for Ivenix Infusion Pumps
FDA identifies Class I recall as most serious type due to software anomalies that may cause unexpected shutdowns and interface freezing.
Labeling
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Admetsys Blood Diagnostic System Made Breakthrough Device
Admetsys announced that the FDA has designated its automated glucose control and continuous blood diagnostics system a Breakthrough Device.
Draft Guidances
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FDA Proposes Ban on Electrical Stimulation Devices
The U.S. FDA has proposed banning electrical stimulation devices for self-injurious or aggressive behavior due to significant risks, marking the second attempt at prohibition, with implications including potential treatment transitions for users and a thorough review of updated evidence and expert opinions.