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Therapixel’s Mammogram Screening Software Cleared

July 13, 2020

The FDA granted Therapixel 510(k) clearance for its MammoScreen AI software designed to help radiologists analyze mammograms for cancer.

The software automatically assesses the images for suspicious lesions and calcifications and evaluates their likelihood of being malignant on a scale of one to ten.

The company said the FDA cleared the product based on results from a study showing that radiologists were better at detecting cancer in mammograms when using the screening software.

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