Tag: FDA clearance

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GE HealthCare Receives FDA Clearance for Diagnostic Imaging Viewer

The zero-footprint diagnostic viewer is designed to give radiologists browser-based access to imaging studies and visualization tools within the Genesis Radiology Workspace.

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FDA Clears Mobile C-Arm System With AI-Enhanced Imaging

The mobile C-arm system features AI-powered imaging tools and cable-free design for interventional procedures.

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FDA Clears for Augmented Reality Navigation Platform for Neurosurgery

The system is designed to give surgeons a clear, real-time view of critical anatomy and planned trajectories.

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GE HealthCare Receives FDA Clearance for Diagnostic Imaging Viewer

The zero-footprint diagnostic viewer is designed to give radiologists browser-based access to imaging studies and visualization tools within the Genesis Radiology Workspace.

FDA Clears Single-Use Cystoscope with Enlarged Working Channel

Oct 1, 2025

The device features a working channel more than 80% larger than comparable single-use models, aiming to improve visualization during procedures.

FDA Clears Device for Real-Time Monitoring of Surgical Drainage

Sep 29, 2025

The inline sensing system is designed for bedside use with post-operative patients to continuously track biochemical data from surgical effluent.

FDA Clears Sentec’s LuMon System for Bedside Lung Imaging

Sep 5, 2025

The LuMon system provides real-time, radiation-free lung imaging for premature infants, children, and adults, helping clinicians tailor respiratory therapy at the bedside.