- No public price. Billing period, trial and refund not stated.
- Not disclosed
- Not disclosed
- —
- 2016
- US
Pathology
PathAI AISight
by PathAI · founded 2016 · US
Cloud image management for digital pathology with AISight Dx, cleared for primary diagnosis, plus biopharma AI services.
On this page
30/100Competitive
- Regulatory & Compliance18/28
FDA cleared (2 K-numbers on record)
- Clinical Integration0/26
No EHR integrations listed
- Evidence Strength0/28.8
No peer-reviewed coverage
- Vendor & Market14.4/18
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 (2 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 papers0/21
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 market6/6
Founded 2016 (10 years)
- Clinician sentiment (Reddit)0/9
No clinician sentiment data available
- Pricing transparency3/5
Pricing on request, no public amounts
Open IMS with AISight Dx + biopharma diagnostic services.
Vendor-agnostic IMS appeals to mixed-vendor labs. Strong biopharma R&D revenue.
Bottom line
AISight is PathAI's cloud image management system for digital pathology, and AISight Dx is cleared by the FDA for primary diagnosis on digital slides of formalin-fixed, paraffin-embedded surgical pathology. It fits a pathology department or health system building a digital workflow, and it is sold by quote to institutions. Roche signed a definitive merger agreement to acquire PathAI on 7 May 2026, and the closing has not been confirmed.
What is AISight and who makes it?
PathAI, Inc. is based in Boston and was founded in 2016 by Andy Beck, its CEO, and Aditya Khosla, its CTO. The company calls itself "a global leader in artificial intelligence (AI) and digital pathology solutions." AISight is described as a cloud-native image management system with multi-slide navigation and an integrated workflow. PathAI also runs a biopharma business offering AI-powered clinical-trial and translational research solutions.
Quest Diagnostics bought the PathAI Diagnostics laboratory, formerly Poplar Healthcare, on 11 June 2024, and PathAI stayed independent and kept its biopharma services. Roche has been a partner since 2021, and in 2024 the partnership widened to companion-diagnostic algorithms. Funding totals disagree across databases: about $255 million over five rounds on CB Insights, about $317 million on HealthTech Alpha.
What happens with the Roche deal?
Roche's announcement of 7 May 2026 puts the price at $750 million upfront plus up to $300 million in milestones, about $1.05 billion in all. Roche expected to close in the second half of 2026, and PathAI remains a separate company until then. After closing it would join Roche Diagnostics.
Roche also sells digital pathology hardware under the Ventana name, while the scanners in the existing clearance are made by Hamamatsu and Leica. Agilent's agreement to buy Proscia, another image management vendor, for $240 million (MedTech Dive, 2026) shows PathAI is not the only platform changing hands.
What is actually cleared?
Two 510(k) clearances sit with PathAI in the FDA database. K212361, decided on 11 August 2022, covers "Novo", the earlier AISight image management system. K243391, decided on 26 June 2025, covers AISight Dx, which PathAI announced on 30 June 2025 as cleared for primary diagnosis.
The cleared configuration works with the Hamamatsu NanoZoomer S360MD and the Leica Aperio GT 450 DX. A predetermined change control plan lets PathAI add scanners, displays, file formats and browsers without a new 510(k). The indication excludes frozen sections, cytology and non-FFPE hematopathology. PathAI also has CE-IVD marking for the EEA, the UK and Switzerland.
The AI algorithms are labelled research use. The clearances cover the viewer and image management system.
What does it cost and how does it connect?
There is no public price. PathAI lists no LIS or EHR integrations, and no HIPAA, SOC 2 or HITRUST attestation. Coverage comes from trade press such as CAP Today, Fierce and HLTH.
Who is it for?
The buyer is a laboratory director moving to digital primary diagnosis. Roche sells Ventana scanners, and the scanners in the cleared configuration are Hamamatsu and Leica.
The verdict
AISight Dx is a cleared digital pathology platform with a viewer-level clearance and research-use algorithms. Its ownership is pending: until Roche's closing is confirmed, PathAI is independent.
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 |
|---|---|---|---|
| Enterprise | — | — | No public price. Billing period, trial and refund not stated. |
Source: vendor pricing page. Last checked October 15, 2026.
What deploys cleanly
Carries FDA 510(k) per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
Who builds it
PathAI AISight (PathAI) was founded in 2016 in US, putting it 10 years into market.
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