Device Information
Indications
The Genius Digital Diagnostics System with the Genius Cervical AI Algorithm is designed for creating and viewing digital images of scanned ThinPrep Pap Test slides. The system aids in cervical cancer screening by identifying atypical cells, cervical neoplasia, including precursor lesions (High and Low-grade Squamous Intraepithelial Lesions), and carcinoma.
- Indication with MedDRA Code: Cervical Neoplasia – MedDRA Code: 10008485
Limitations
The system is intended for in vitro diagnostic use and should only be used by qualified cytologists and pathologists. Digital images should be reviewed in conjunction with the patient’s screening history and other risk factors.
Study Results
Multiple studies confirmed that the Genius Digital Diagnostics System with the Genius Cervical AI Algorithm meets performance requirements. The device showed high sensitivity and specificity for detecting cervical abnormalities compared to manual slide review, with improved sensitivity in detecting LSIL, ASC-H, and HSIL categories.
Regulatory Information
The device is regulated under 21 CFR 864.3900 as a Class III device. It underwent evaluation as a De Novo request, which was granted.
Manufacturer Information
- Name: Hologic Inc.
- Address: 250 Campus Drive, Marlborough, MA 01752, USA
- Contact Details: Phone: +1 508-263-2900, Website: https://www.hologic.com/
Predicate Device Information
No predicate device, as this is a De Novo request.
Implications
The system offers enhanced sensitivity for detecting cervical abnormalities, potentially improving early detection of cervical cancer and related conditions.
References
- Genius™ Digital Diagnostics System. DEN210035. FDA summary link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210035
- https://www.hologic.com/hologic-products/cytology/genius-digital-diagnostics-system
- https://www.hologic.com/hologic-products/cytology/genius-cervical-ai
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