FDA Clears Therapixel’s MammoScreen AI for Mammography Interpretation

FDA has granted 510(k) clearance to Therapixel for MammoScreen (version 5), an artificial intelligence software that aids mammography interpretation. The clearance covers use as a computer-aided detection device.

• The device is a mammography computer-aided detection (CAD) software (FDA product code QDQ).
• Cleared via the 510(k) pathway, which relies on substantial equivalence to a previously cleared predicate device; specific clinical performance data were not provided in the clearance announcement.

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