FDA Radiology AI Devices
Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.
Galen™ Second Read™ is a software tool that analyzes digital images of prostate biopsy slides to identify regions suspicious for prostate cancer. It flags slides initially diagnosed as benign if it detects potential cancer areas, providing pathologists with case-level alerts and heatmaps to assist in further review. This helps improve cancer detection beyond the initial pathology review but is not intended to replace standard pathology diagnosis.
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