Galen™ Second Read™
Ibex Medical Analytics Ltd.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.
Intended Use
Analyze scanned histopathology whole slide images from prostate core needle biopsies to identify cases initially diagnosed as benign for further pathological review by flagging tissue suspicious for prostate adenocarcinoma with heatmaps.
Technology
The device is a cloud-hosted software using a deterministic deep convolutional neural network architecture developed to analyze digitized whole slide images from H&E-stained prostate biopsies. It processes WSIs scanned by Philips Ultra Fast Scanner, delivering binary likelihood classification for presence of prostate adenocarcinoma and generates heatmaps highlighting suspicious regions, intended to augment pathologist review.
Performance
Performance testing included analytical studies demonstrating high precision and localization accuracy in identifying prostate adenocarcinoma in WSIs, and clinical validation showing improved detection sensitivity by pathologists assisted by the device. Sensitivity of the AI tool at slide level was around 81%, and pathologists using the tool showed sensitivity improvement versus standard care.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/2/2024
8 months - 2
FDA Approval
1/24/2025
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