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Hologic, Inc.
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Genius Digital Diagnostics System with the Genius Cervical AI algorithm is an FDA 510(k)-cleared medical device (DEN210035) manufactured by Hologic, Inc.. This device is classified under the Pathology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 30, 2024. Regulation: 8.