The First AI-Driven Diagnostic to Earn FDA ‘Breakthrough’ Status In a milestone for artificial intelligence in medicine, Roche’s VENTANA TROP2 (EPR20043) RxDx test has become the first AI-powered diagnostic to receive the FDA’s coveted Breakthrough Device Designation roche.com clpmag.com. This computational pathology companion diagnostic – essentially a software-driven analysis of cancer biopsy images – gained…
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