Hologic deployed the Genius Digital Diagnostics System, combining AI with digital imaging to help cytologists and pathologists screen ThinPrep Pap test slides for cervical cancer and pre-cancerous cells. The system received FDA clearance in February 2024, making it the first and only FDA-cleared digital cytology system of its kind.

The Genius Digital Diagnostics System consists of the Genius Digital Imager, the Genius Cervical AI algorithm, a secure Image Management Server, and a high-resolution Review Station. The deep learning-based Genius Cervical AI algorithm runs on a local server (edge computing) and analyzes all cells on a digitized ThinPrep Pap test slide, narrowing tens of thousands of cells down to a curated gallery of the most diagnostically relevant images for cytologist review. Clinical studies showed the system reduced false negatives for high-grade squamous intraepithelial lesions by 28% compared to standard microscopic review, and reduced per-case review time by approximately 50%. The system was commercially available in Europe, Australia, and New Zealand before the US FDA clearance.