Breakthrough Status

FDA Grants Breakthrough Status for Ibex Medical’s Cancer Detection Platform

June 7, 2021

Ibex Medical has received FDA’s Breakthrough Device designation for its Galen cancer detection platform.

According to the company, the artificial intelligence (AI)-powered platform is the first used in routine clinical practice in pathology labs in Europe and Puerto Rico, and has shown success in improving the accuracy of diagnoses for prostate and breast cancer.

The system, which currently can only be used for research purposes in the U.S., is designed to detect and grade prostate and breast cancer tumors.

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