Freenome vs PathAI AISight
PathAI's AISight Dx (K243391, June 26, 2025) is a cloud image management system cleared for primary diagnosis of FFPE surgical pathology slides, which makes it a purchase for a pathology department going digital. The clearance names the Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX and excludes frozen sections, cytology and non-FFPE hematopathology. PathAI labels its algorithms research use. Roche's release of May 7, 2026 says it will acquire PathAI for $750 million upfront plus up to $300 million in milestones, with closing expected in the second half of 2026.
A family physician screening average-risk adults 45 and older looks at Freenome instead, since PathAI sells image management to pathologists. SimpleScreen CRC was approved as PMA P250029 on July 24, 2026. Freenome has traded on the Nasdaq Capital Market as FRNM since July 21, 2026 and raised $254 million in February 2024, led by Roche.
Pathology · Reviewed November 2, 2026
Freenome
by Freenome · founded 2014
FDA-approved SimpleScreen CRC blood test for colorectal cancer screening in adults 45 and older at average risk.
PathAI AISight
by PathAI · founded 2016
Cloud image management for digital pathology with AISight Dx, cleared for primary diagnosis, plus biopharma AI services.
When to pick each one
Freenome
- PMA-approved, P250029, July 2026
- Indicated for adults 45 and older, average risk
PathAI AISight
- AISight Dx cleared for primary diagnosis, June 2025
- Cleared on Hamamatsu and Leica scanners
- CE-IVD for EEA, UK and Switzerland
Score
Each row shows points earned of points available under the published rubric.
Freenome
40of 100
PathAI AISight
40of 100
| Dimension | Freenome | PathAI AISight | 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 / 21 | 0 / 21 | 0 |
| RCT / meta-analysis / systematic review | 0 / 7.8 | 0 / 7.8 | 0 |
| Funding & adoption signal | 8.4 / 12 | 8.4 / 12 | 0 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 6 / 6 | 6 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Freenome
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
PathAI AISight
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Billing period, trial and refund not stated. |
Evidence
Freenome
FDA decisions
P250029 (opens in new tab)PMA2026-07-24
SimpleScreen CRC
PathAI AISight
FDA decisions
K243391 (opens in new tab)510(k)2025-06-26
AISight Dx
K212361 (opens in new tab)510(k)2022-08-11
Novo
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Freenome | PathAI AISight |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | 2014 | 2016 |
| HQ | US | US |
Scroll horizontally to see both columns.
Common questions
Open the full pathology comparison
Digital pathology workflows with FDA-cleared cancer detection (prostate, breast, colon), IHC scoring (HER2, Ki67), and AI-powered image management. Tempus, PathAI, Proscia dominate.