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# Hologic’s Cervical Cancer Diagnostic Cleared
- URL: https://www.fdaweb.com/hologics-cervical-cancer-diagnostic-cleared/
- Published: 2024-02-02T12:00:00.000Z
- Updated: 2026-09-14T14:22:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156278

FDA has cleared a Hologic 510(k) for its Genius Digital Diagnostics System with the Genius Cervical AI algorithm, a digital cytology system that the company says combines deep-learning-based artificial intelligence with volumetric imaging technology to help identify pre-cancerous lesions and cervical cancer cells.

Traditional screenings for cervical cancer include a Pap test, where a sample is collected at an OB-GYN office and sent to a lab for examination under a microscope, according to the company. “With the Genius Digital Diagnostics System, the glass slides are digitally imaged and an artificial intelligence algorithm is applied to pinpoint the cells that cytologists and pathologists should review,” it says.

Hologic also notes that the device offers the opportunity for greater collaboration across lab and other healthcare settings. “The system allows cytologists and pathologists to securely review cases remotely, so patients can benefit from the collective knowledge of geographically dispersed experts,” it says.