AI-powered digital pathology platform providing FDA-cleared diagnostic tools, biomarker analysis, and enterprise workflow management for laboratories and biopharma companies.
AI-powered digital pathology platform providing FDA-cleared diagnostic tools, biomarker analysis, and enterprise workflow management for laboratories and biopharma companies.
PathAI builds AI-powered pathology software that helps laboratories and pharmaceutical companies analyze tissue samples with greater accuracy and efficiency. The company's flagship product, AISight, is a cloud-native digital pathology platform that serves as a central hub for case management, slide image management, and AI-powered diagnostic applications across histopathology workflows.
PathAI received FDA 510(k) clearance for AISight Dx in 2022, and in 2025 obtained additional FDA clearance with a Predetermined Change Control Plan (PCCP) that allows specific future AI enhancements without new regulatory submissions. This regulatory approach positions PathAI ahead of most competitors in the digital pathology space.
The platform's AI algorithms are trained on over 15 million pathologist-verified annotations and can detect and grade cancers across multiple tumor types including breast, lung, head and neck, and gastrointestinal cancers. For biopharma clients, PathAI provides standardized biomarker quantification for clinical trials, helping pharmaceutical companies evaluate drug efficacy with consistent, reproducible pathology data.
PathAI operates the Precision Pathology Network (PPN), launched in 2025, which connects laboratories globally to share AI-powered pathology tools, monetize real-world pathology data, and support biopharma-sponsored evidence generation studies. The company also maintains an in-house CAP/CLIA-certified GCLP histopathology lab for end-to-end clinical trial support.
With approximately $240M in funding raised and partnerships with 90% of the top 15 biopharma companies, PathAI targets enterprise deployments at academic medical centers, reference laboratories, integrated delivery networks, and pharmaceutical companies. Notable partnerships include Moffitt Cancer Center and Quest Diagnostics.
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Cloud-native enterprise workflow system that centralizes case management, whole-slide image management, and AI diagnostic applications in a single hub for anatomic pathology laboratories.
Use Case:
Large hospital pathology departments replacing manual slide workflows with digital-first operations, enabling remote consultation and AI-assisted primary diagnosis.
510(k)-cleared platform for AI-powered primary diagnosis with a Predetermined Change Control Plan allowing iterative AI improvements without new FDA submissions.
Use Case:
Clinical laboratories deploying AI-assisted cancer detection and grading for breast, lung, and GI cancers with full regulatory compliance for diagnostic use.
Standardized, reproducible AI-powered biomarker analysis across tissue samples for pharmaceutical clinical trials, reducing inter-reader variability in pathology scoring.
Use Case:
Pharma companies running oncology clinical trials that need consistent PD-L1 scoring, HER2 quantification, or tumor-infiltrating lymphocyte analysis across multiple trial sites.
Global network of digital pathology laboratories launched in 2025 that provides early access to AI tools, enables real-world data monetization, and supports biopharma evidence generation studies.
Use Case:
Regional pathology labs joining a collaborative network to access cutting-edge AI algorithms while generating revenue from anonymized pathology data contributions.
CAP/CLIA-certified laboratory operated by PathAI that provides end-to-end tissue processing, staining, scanning, and AI analysis for clinical trial sponsors.
Use Case:
Biopharma companies outsourcing entire pathology workflows for Phase II/III clinical trials to a single vendor with integrated AI-powered analysis.
Custom pricing based on slide volume, AI applications, and deployment scope
Project-based pricing for clinical trial pathology services
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