Opportunity
Federal Register #2026-22593
FDA Class II classification of Hologic Genius AI-assisted cervical cytology system
Buyer
Food and Drug Administration
Posted
November 05, 2026
Identifier
2026-22593
The FDA issued a final regulatory order covering Hologic’s AI-assisted digital cervical cytology system. - Government buyer / issuing agency: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA); no purchasing office or procurement buyer is identified. - OEM: Hologic Inc. requested De Novo classification for the Genius Digital Diagnostics System with the Genius Cervical AI algorithm. - Product: A prescription in vitro diagnostic system that creates, views, and manages digital images of Pap test and conventional Pap smear slides. Its AI highlights areas of interest to support cytology review. - Classification and requirements: Class II medical device subject to special controls, including detailed labeling and instructions, design verification and validation, analytical and clinical performance studies, screening-workload assessment, and human-factors testing. - Procurement status: This is a regulatory classification action, not a procurement or award. No quantities, part numbers, contract value, or period of performance are specified.
Description
The FDA classifies the digital cervical cytology slide imaging system with artificial intelligence algorithm as a class II device subject to special controls. The prescription in vitro diagnostic system creates, views, and manages digital slides from Pap test specimens and conventional Pap smears, and uses an AI algorithm to identify areas of interest to assist with cytology diagnosis. The order identifies special controls, including labeling requirements and design verification and validation testing. The classification was applicable January 31, 2024, and the final order is effective November 5, 2026.