- No public price. Sold with Hologic 3D Mammography systems.
- Not disclosed
- Not disclosed
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- US
Radiology
Hologic Genius AI
by Hologic · US
Genius AI family from Hologic: Genius AI Detection for 3D mammography and Genius Cervical AI for cytology.
On this page
26/100Niche fit
- Regulatory & Compliance18/28
FDA cleared (5 K-numbers on record)
- Clinical Integration0/26
No EHR integrations listed
- Evidence Strength0/26
No peer-reviewed coverage
- Vendor & Market8.4/18
Mid-tier funding and adoption
- Sentiment & Transparency2.5/14
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance18/18
FDA cleared (5 K-numbers on record)
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/14
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/8
None of the top-3 EHRs covered
- Bidirectional write-back0/4
No bidirectional write-back documented
- Peer-reviewed papers0/18
No peer-reviewed coverage
- RCT / meta-analysis / systematic review0/8
No RCT, meta-analysis, or systematic review
- Funding & adoption signal8/12
Mid-tier funding and adoption
- Years in market0/6
Founded year not recorded
- Clinician sentiment (Reddit)0/9
No clinician sentiment data available
- Pricing transparency3/5
Pricing on request, no public amounts
Genius AI family from Hologic: Genius AI Detection for 3D mammography and Genius Cervical AI for cytology.
No public price. Sold with Hologic 3D Mammography systems.
Bottom line
Genius AI is Hologic's family of FDA-cleared AI software, and the lead product is Genius AI Detection for breast tomosynthesis. It marks suspicious lesions, scores each case and helps order the reading worklist. Compatibility is named for Hologic's Selenia Dimensions, 3Dimensions and Envision platforms. The headline accuracy claims are Hologic's and come with caveats printed in its own footnotes.
Who sells Genius AI?
Hologic, based in Marlborough, Massachusetts, sells the family. Besides the mammography product there is the Genius Digital Diagnostics System with the Genius Cervical AI algorithm, a cytology product cleared through the De Novo pathway as DEN210035 in January 2024.
Blackstone and TPG announced the acquisition of Hologic on 21 October 2025. The deal closed on 7 April 2026, the stock came off Nasdaq and Joe Almeida became CEO, according to an SEC filing.
What does it do?
Genius AI Detection is deep-learning software that finds lesions on each tomosynthesis slice and gives location, outline and confidence. Version 2.0 correlates findings between CC and MLO views automatically. It also produces:
- A Case Score, the AI's confidence that an exam contains a malignant lesion.
- A Case Complexity Index.
- A Reading Priority Indicator that flags about 8 to 10 percent of the most concerning cases.
- A Read Time Indicator, and worklist integration with SecurView 12.0.
It sits in the Dimensions suite beside 3DQuorum SmartSlices and Quantra density software. Feature availability depends on the PACS vendor.
What is the regulatory record?
Four clearances cover the mammography product: K201019 (November 2020), K221449 (October 2022) for version 2.0, K230096 (May 2023) adding CC-MLO correlation, and K243341 (July 2025), which also names the Envision platform. It is Class II software under 21 CFR 892.2090, product code QDQ.
What does the evidence say?
The performance claims on the product page are Hologic's: 94 percent sensitivity from FDA documents, a 9 percent gain in reader sensitivity and 70 percent fewer false markings than the older ImageChecker CAD. Its own footnotes say the analyses "do not control type I error", and read time was longer with CAD, 52.0 seconds against 46.3. A Hologic press release describes a Massachusetts General Hospital study of 7,500 screening exams in which the AI flagged about a third of cancers that the first reader called negative. A third-party summary on physicianaitools.com reports specificity of 37 to 41 percent. Neither source is a peer-reviewed paper.
How is it sold?
Genius AI Detection is bundled with Hologic's 3D mammography systems and sold as part of that purchase, with no separate price published.
The verdict
Genius AI Detection has four FDA clearances since 2020 and is sold inside Hologic's 3D mammography platforms. The sensitivity and false-marking figures behind it come from Hologic.
Editorial review last generated October 15, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| OEM-bundled | — | — | No public price. Sold with Hologic 3D Mammography systems. |
Source: vendor pricing page. Last checked October 15, 2026.
What deploys cleanly
Carries FDA 510(k), FDA De Novo per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
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