PathAI builds AISight, a cloud-native digital pathology platform for anatomic pathology labs, health systems, academic medical centers, and biopharma companies. It centralizes whole-slide image management, case prioritization, and remote collaboration. Pathologists view slides in a browser and run AI algorithms for quality control, tumor detection, and biomarker scoring.
The platform is scanner-agnostic. It ingests images from Hamamatsu, Leica, Roche, and Philips scanners. AISight also functions as an open ecosystem, embedding third-party algorithms from partners such as Paige, Visiopharm, Deep Bio, and DoMore Diagnostics alongside PathAI’s own tools in a single viewer.
PathAI offers two regulatory tracks. AISight Dx is FDA-cleared and CE-IVD marked for primary clinical diagnosis, but only with specific scanner models. A broader suite of algorithms, covering biomarker quantification and disease severity scoring, is designated Research Use Only in the US.
In May 2026, Roche announced a definitive merger agreement to acquire PathAI for $750 million upfront plus up to $300 million in milestone payments. The deal was pending antitrust and regulatory approval at the time of writing, with closing expected in the second half of 2026.
Pricing
PathAI does not publish pricing on its website. There is no listed free plan, free trial, or self-serve signup. Enterprise pricing, per-slide fees, and licensing costs are determined through direct sales contact and a demonstration request. Prospective customers must email PathAI or submit a form to receive a custom quote.
* Disclaimer: Please note that pricing information may not be up to date. For the most accurate and current pricing details, refer to the official website.
Key Features
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Cloud-native image management system with no local server needed
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FDA-cleared AISight Dx platform for primary clinical diagnosis
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Open LIS integration through the AISight Link API
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Automated slide quality control with ArtifactDetect
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Tumor case prioritization through the TumorDetect algorithm
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Multi-partner AI portfolio embedded in one native viewer
Use Cases
Primary Clinical Diagnosis
Pathologists at health systems move from optical microscopes to browser-based slide review for routine patient care. Using the FDA-cleared AISight Dx platform, labs link high-resolution images directly to patient records in the LIS.
Automated Quality Control
Histology labs process high slide volumes daily and need to catch preparation defects early. ArtifactDetect flags blurred or folded slides before review, while TumorDetect surfaces likely tumor cases for faster follow-up.
Quantitative Biomarker Scoring
Translational research teams need reproducible scoring for immuno-oncology and hormone receptor markers. Algorithms such as AIM-PD-L1 and AIM-HER2 calculate staining intensity percentages across whole-slide images for research data.
Clinical Trial Standardization
Biopharma companies running multi-site trials need consistent histopathological endpoints. Tools like the FDA-qualified AIM-MASH and AIM-HI UC score tissue against recognized indexes such as Geboes, Nancy, and Robarts scales.
Remote Multi-Site Consultation
Healthcare networks often need second opinions or tumor board reviews across distant locations. AISight lets pathologists share, annotate, and review digital slides in real time without shipping physical glass.
Spatial Biology Research
Oncology researchers look for morphological signatures that predict therapeutic response. Tools like PathExplore and IHCExplore extract single-cell spatial data from tissue sections to correlate with clinical outcomes.
Strengths & Weaknesses
Strengths
AISight Dx holds FDA 510(k) clearance and CE-IVD marking for primary diagnosis.
The platform natively ingests images from Leica, Hamamatsu, Roche, and Philips scanners.
Third-party algorithms from Paige, Visiopharm, Deep Bio, and DoMore run in one unified viewer.
AISight Link provides an open API to sync with existing Laboratory Information Systems.
Models are trained on input from over 500 board-certified pathologists and 2.0 million annotations.
Weaknesses
Many algorithms, including AIM-PD-L1 and AIM-HER2, are Research Use Only in the US and cannot be used diagnostically.
FDA clearance for primary diagnosis applies only to specific scanner models from three vendors.
Pricing, licensing structures, and setup fees are not published anywhere on the website.
There is no self-serve trial; access requires a demo request and an enterprise sales process.
Who Is This For?
Anatomic pathology labs and health systems replacing glass-based workflows with a cloud-native, LIS-connected IMS.
Biopharmaceutical companies needing trial-ready biomarker algorithms and exploratory spatial biology tools for drug development.
Academic medical centers and research institutions running digital case consultations and multi-institution studies.
Contract research organizations and reference labs that need automated slide QC and standardized trial scoring.
Frequently Asked Questions
Is AISight Dx cleared for primary diagnosis in the US?
Yes. AISight Dx received FDA 510(k) clearance on June 30, 2025, but only when used with cleared scanners from Hamamatsu, Leica, or Roche.
Can the biomarker algorithms be used for patient diagnosis in the US?
No. Algorithms such as AIM-PD-L1, AIM-HER2, and PathAssist Derm are labeled Research Use Only in the US and are not approved for diagnostic reporting.
Does PathAI require on-premises hardware?
No. AISight runs as a browser-accessible cloud platform, so labs do not need dedicated local servers.
How much does PathAI cost?
Pricing is not published. Labs and biopharma organizations must contact PathAI directly for a custom quote based on volume and configuration.
Which slide scanners work with AISight?
AISight ingests images from Hamamatsu, Leica, Roche, and Philips scanners, though primary diagnostic clearance is limited to specific models.
Can I try PathAI before committing?
There is no self-serve trial. Access starts with a demonstration request and a technical scoping conversation with the vendor.
Which third-party algorithms are available inside AISight?
The platform integrates algorithms from Deep Bio, Paige, Visiopharm, and DoMore Diagnostics within its Multi-Partner AI Portfolio.
Is PathAI still an independent company?
In May 2026 Roche announced a definitive agreement to acquire PathAI. The deal had not yet closed at the time of writing and remained subject to regulatory approval.
How does data export back to the lab work?
Finalized results, including cell counts and biomarker scores, sync back to the Laboratory Information System through the AISight Link API.
What security standards does PathAI follow?
PathAI states that AISight is ISO 27001 certified and follows standard healthcare privacy and security frameworks.
PathAI integrates with hardware from Hamamatsu (NanoZoomer S360MD), Leica (Aperio GT 450 DX), Roche (VENTANA DP200/DP600), and Philips scanners. It connects to Laboratory Information Systems through the open AISight Link API. It also embeds third-party algorithm partners Deep Bio, Paige, Visiopharm, and DoMore Diagnostics directly inside the AISight viewer.