Hologic Genius Digital Diagnostics System AI
Hologic · hologic.com ↗
Digital cytology system with the Genius Cervical AI algorithm for reviewing ThinPrep Pap test images.
PricingUnverified · not published or not confirmed (checked 2026-10-14)
Ranked in
Last checked2026-10-14
AI status
AI product On FDA AI-enabled device list (DEN210035) · source
Compliance profile
| Field | Status | Detail | Source | Checked |
|---|---|---|---|---|
| FDA | Verified | De Novo granted · DEN210035 | accessdata.fda.gov | 2026-10-14 |
| HIPAA | Unverified | Not found on vendor pages we checked | — | 2026-10-14 |
| BAA | Unverified | Not found on vendor pages we checked | — | 2026-10-14 |
| SOC 2 | Unverified | Not found on vendor pages we checked | — | 2026-10-14 |
| HITRUST | Unverified | Not found on vendor pages we checked | — | 2026-10-14 |
| Epic integration | Unverified | Not found on vendor pages we checked | — | 2026-10-14 |
Vendor-stated means the claim appears on the vendor’s site; we have not audited it. Unverified means we found no source, which is not a negative finding. Vendors can request a correction.
FDA records
From the FDA AI-enabled medical devices list. Wording follows FDA: 510(k) “cleared”, De Novo “granted”. Clearance applies to the specific indication in the FDA record.
| Number | Device (as listed) | Pathway | Decision date | Panel |
|---|---|---|---|---|
| DEN210035 | Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm | De Novo granted | 01/31/2024 | Pathology |
Alternatives
Information about software products for healthcare professionals. Not medical advice, not an endorsement. Verify all details with the vendor. We never collect patient information (PHI).