Hologic Genius AI vs Pearl
Hologic sells Genius AI Detection with its 3D Mammography systems, so the purchase happens inside a mammography suite on Selenia Dimensions, 3Dimensions or Envision. Its latest openFDA record, K243341 from July 31, 2025, covers lesion location, outline, a confidence score and an exam case score on tomosynthesis. The product page adds a Reading Priority Indicator that flags about 8 to 10 percent of cases and worklist integration with SecurView 12.0.
Pearl is booked through a demo and runs on the dentist's own imaging and practice software. Pearl's FAQ lists up to 18 findings per image on bitewing, periapical and panoramic films and names DEXIS, Open Dental and Eaglesoft among its integrations. openFDA shows 8 Second Opinion decisions, from the first caries clearance (K210365) to a CBCT module (K243989) and a panoramic one (K250525). Pearl's own figures conflict: the home page says more than 29,000 practices and 26+ clearances, while the About page says 23k+ practices and 26 clearances.
A dental group's decision turns on Pearl's integration list, and a breast center's on whether its tomosynthesis fleet is Hologic hardware.
Radiology · Reviewed November 2, 2026
Hologic Genius AI
by Hologic
Genius AI family from Hologic: Genius AI Detection for 3D mammography and Genius Cervical AI for cytology.
Pearl
by Pearl Inc. · founded 2019
FDA-cleared dental x-ray AI (Second Opinion) that marks caries, bone loss and restorations, for dentists and DSOs.
When to pick each one
Hologic Genius AI
- Sold with Hologic 3D Mammography systems
- Lesion outlines and case score on tomosynthesis, K243341
Pearl
- Pearl lists up to 18 findings per image
- Integrations with DEXIS, Open Dental and Eaglesoft
Score
Each row shows points earned of points available under the published rubric.
Hologic Genius AI
35of 100
Pearl
33of 100
| Dimension | Hologic Genius AI | Pearl | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 18 / 18 | 0 |
| HIPAA / SOC2 / BAA | 0 / 10 | 0 / 10 | 0 |
| EHR integrations (count) | 0 / 4.2 | 0 / 4.2 | 0 |
| Top-3 EHR coverage (Epic / Oracle / Athena) | 0 / 2.4 | 0 / 2.4 | 0 |
| Peer-reviewed papers | 0 / 18.2 | 0 / 18.2 | 0 |
| RCT / meta-analysis / systematic review | 0 / 7.8 | 0 / 7.8 | 0 |
| Funding & adoption signal | 8.4 / 12 | 3 / 12 | +5.4 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 4.2 / 6 | -4.2 |
Scroll horizontally to see every column.
Pricing
Hologic Genius AI
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| OEM-bundled | n/a | n/a | No public price. Sold with Hologic 3D Mammography systems. |
Pearl
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
Hologic Genius AI
FDA decisions
K243341 (opens in new tab)510(k)2025-07-31
Genius AI Detection 2.0
DEN210035 (opens in new tab)De Novo2024-01-31
Genius Digital Diagnostics System with Genius Cervical AI algorithm
K230096 (opens in new tab)510(k)2023-05-23
Genius AI Detection 2.0 with CC-MLO Correlation
K221449 (opens in new tab)510(k)2022-10-06
Genius AI Detection 2.0
K201019 (opens in new tab)510(k)2020-11-18
Genius AI Detection
Pearl
FDA decisions
K250525 (opens in new tab)510(k)2025-11-14
Second Opinion Panoramic
K243234 (opens in new tab)510(k)2025-06-12
Second Opinion CS
K243989 (opens in new tab)510(k)2025-05-23
Second Opinion 3D
K243230 (opens in new tab)510(k)2025-05-09
Second Opinion BLE
K243893 (opens in new tab)510(k)2025-05-05
Second Opinion Pediatric
Show 3 more
K242600 (opens in new tab)510(k)2025-04-11
Second Opinion Periapical Radiolucency Contours
K242522 (opens in new tab)510(k)2025-01-16
Second Opinion CC
K210365 (opens in new tab)510(k)2022-03-04
Second Opinion
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Hologic Genius AI | Pearl |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | 2019 |
| HQ | US | US |
Scroll horizontally to see both columns.
Common questions
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Acute-care triage, mammography screening, CCTA plaque analysis, mobile MRI. 30+ FDA-cleared platforms across stroke, oncology, cardiac. Enterprise sales only — we compared what's deployed where.