Physician-reviewed

Pathology AI, explained by a pathologist.

Digital pathology and AI-assisted diagnosis, with honest verdicts from a physician who has spent a career at the microscope.

Status: shortlist researched from each vendor’s own information and the FDA’s public lists, checked 19 Oct 2026. None of these vendors publishes prices. Hands-on evaluation is in progress — no tool is ranked until it has been checked by our Chief Medical Editor.

The shortlist

Pathology AI is not one product. Some tools look for cancer on a slide, some are slide-viewing platforms with AI built in, and some score stains such as HER2 or PD-L1. Compare within a category. Regulatory status below is what the vendor states or what appears on the FDA list; it varies by product and by country, and many AI modules from the same vendor are research use only.

ToolWhat it doesCategoryRegulatory status (as stated)PricingOur status
Paige (part of Tempus)Cancer detection suites (prostate, breast, GI, pan-cancer) and foundation modelsCancer detectionPaige Prostate: FDA De Novo (DEN200080, Sept 2021), on the FDA AI list. Other products: ask the vendorNot published; demoResearched
IbexProstate biopsy detection (Ibex Prostate Detect), plus breast and gastric toolsCancer detectionIbex Prostate Detect: FDA 510(k) (K241232, Jan 2025, listed as Galen Second Read) to flag possible missed cancer in prostate core biopsies. Other Ibex solutions are research use only in the US; the vendor states some are CE-IVD under IVDRNot published; demoResearched
AiforiaCloud platform with breast, lung, prostate, colon and gastric modelsCancer detectionIVDR certification announced Feb 2025, with CE-IVD models including breast HER2 and prostate. No FDA status statedNot published; demoResearched
PathAI (AISight Dx)Slide-viewing and image management platform; AI for clinical-trial researchPlatform with AIAISight Dx: FDA 510(k) (K243391) and CE-IVDR, both as a slide viewer for primary diagnosis on FFPE tissue, not as an AI algorithm. The research version, AISight, is research use onlyNot published; demoResearched
Proscia (Concentriq AP-Dx)Digital pathology platform for primary diagnosis; runs AI apps from Proscia and third partiesPlatform with AIConcentriq AP-Dx: FDA 510(k) (first K230839, Feb 2024) as a slide viewer for primary diagnosis on FFPE tissue with specified scanners; not for frozen sections, cytology or non-FFPE haematopathology. Vendor also states Health Canada licence and CE-IVDR. AI apps carry their own statusNot published; demoResearched
Indica Labs (HALO AP)Pathology platform with clinical modules (prostate, breast IHC, lung PD-L1, slide QC)Platform with AIHALO AP Dx: FDA 510(k) (K232833) as a slide viewer for primary diagnosis with a Hamamatsu scanner. HALO AP: CE-IVDR per vendor; research use only in the US. Prostate AI: CE-IVD per vendor. Other modules: not statedNot published; demoResearched
VisiopharmOver 130 image-analysis apps, including HER2 breast and PD-L1 lungImage analysis & IHC scoringVendor states its diagnostic apps are IVDR-certified; all other products research use only. No FDA status statedNot published; demoResearched
MindpeakBreast, HER2 and PD-L1 suites; assisted diagnosis and macrodissection toolsImage analysis & IHC scoringVendor states 11 CE-IVD products and IVDR certification (Sept 2026); its site marks breast HER2, Ki-67, ER, PR and lung PD-L1 as CE-marked and many others research use only. No FDA status statedNot published; demoResearched
Lunit SCOPETumour microenvironment, IHC (HER2, PD-L1) and immuno-oncology analysisImage analysis & IHC scoringCE-IVD mark (under the older IVDD) announced for SCOPE PD-L1 TPS in 2022; other SCOPE products are sold as research use only. Not on the FDA AI listNot publishedResearched

Ownership is changing. Tempus acquired Paige in 2025. Roche agreed in May 2026 to acquire PathAI, and Agilent agreed in October 2026 to acquire Proscia; neither deal had closed when we checked. Confirm who you would be contracting with.

How to choose in six questions

  1. Is it cleared for your region and your exact use? A cleared viewer is not a cleared AI algorithm. Ask for the clearance of each module you plan to use, for your tissue type, stain and scanner.
  2. Does it work with your scanner and slides? Many clearances name specific scanners and exclude frozen sections, cytology or special stains.
  3. Has it been validated on your own cases? Stain, scanning and population differences change performance. Run a local validation before reporting from it.
  4. Does it fit your LIS and workflow? Results should reach the pathologist inside the normal worklist, not on a separate screen.
  5. Where do slides and data go? Ask about cloud hosting, storage costs, de-identification and your local privacy rules.
  6. Who is responsible? The AI assists. The pathologist signs out the case and stays accountable for it.
Note: a regulatory clearance shows a tool met a safety and effectiveness standard for a stated use. It does not show the tool will improve your diagnoses or save your laboratory time. Vendor claims here are the vendor’s own, not our findings.

Sources

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