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AI Cancer Diagnostics Firm Ibex Granted FDA Breakthrough Device Designation
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Pathologists review a cancer alert on Ibex’s AI solution. Courtesy
Israeli AI-powered cancer diagnostics company Ibex Medical Analytics announced on Wednesday that it was granted Breakthrough Device Designation by the US Food and Drug Administration (FDA) for its Galen platform that helps pathologists detect and grade cancer in biopsies.
Ibex’s Galen Prostate and Galen Breast are the first AI-powered cancer diagnostics solutions in routine clinical use in pathology and are deployed in labs worldwide. The Galen platform offers the Ibex First Read and the Ibex Second Read, applications that analyze cases prior to human pathologist review, enabling case prioritization, and in parallel with human pathologist review to identify any discrepancies, respectively. The Second Read system for breast and prostate biopsies have been used at the Pathology Institute of Maccabi Healt