Tag: FDA clearance

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FDA Clears Deep Learning Technology for High-Resolution CT Imaging

The software is designed to enhance spatial resolution and suppress artifacts in pulmonary, musculoskeletal, and inner ear scans.

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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 Deep Learning Technology for High-Resolution CT Imaging

The software is designed to enhance spatial resolution and suppress artifacts in pulmonary, musculoskeletal, and inner ear scans.

FDA Clears for Augmented Reality Navigation Platform for Neurosurgery

Dec 19, 2025

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

FDA to Accept De-identified Data for Certain Medical Devices Submissions

Dec 19, 2025

New guidance permits the use of de-identified data without requiring individual patient information in marketing submissions.

FDA Clears Robotic-assisted Surgery System for Urologic Procedures

Dec 5, 2025

The system is indicated for use in minimally invasive urologic surgical procedures including prostatectomy, nephrectomy, and cystectomy.

FDA Clears Sirona Cloud-Native Imaging Suite for PET-CT Support

Nov 5, 2025

The platform’s 510(k) clearance adds PET-CT workflows—including SUV quantification, fusion, MIP, and MPR—to its browser-based diagnostic environment, advancing unified cloud imaging infrastructure.