PathAI

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PathAI delivers AI-powered pathology solutions for biopharma and anatomic pathology labs, enabling biomarker discovery, digital pathology workflows, and FDA-cleared clinical diagnostics.

Data & Analytics

AI Models & Infrastructure

Research & Education

About

PathAI is a leading AI-powered pathology company dedicated to improving patient outcomes through advanced machine learning and meaningful collaboration with biopharma, laboratories, and clinicians. Its flagship product, AISight®, is a cloud-native intelligent enterprise workflow solution used by the world's top laboratories and research centers to power digital pathology workflows and AI applications. AISight® serves as a central hub for case management, image management, and best-in-class AI tools enabling multiple histopathology use cases. PathAI's suite of AI algorithm products includes TumorDetect, AIM-Tumor, AIM-PDL1, AIM-HER2, AIM-MASH, METPredict, and more—enabling precise biomarker quantification and workflow optimization. For biopharma partners, PathAI supports every phase of drug and diagnostic development, from translational research and clinical development to companion diagnostics and real-world data analysis. The company's proprietary pathologist contributor network includes 450+ board-certified pathologists who have contributed over 32.5 million annotations for training and validation of AI algorithms. PathAI's technology is trusted by 90% of the top 15 biopharma companies globally. The platform has received FDA clearance for primary diagnosis and FDA qualification for MASH clinical trial endpoints, underscoring its regulatory credibility and clinical-grade performance.

Key Features

AISight® Digital Pathology Platform: A cloud-native enterprise workflow solution for case management, image management, and AI-enabled histopathology—FDA cleared and CE-IVDR marked.
AI Algorithm Suite: A comprehensive library of validated AI algorithms including TumorDetect, AIM-PDL1, AIM-MASH, METPredict, and more for biomarker quantification and workflow optimization.
BioPharma AI Services: End-to-end support for translational research, clinical development, companion diagnostics, and real-world data to accelerate drug development.
Precision Pathology Network: Access to a proprietary network of 450+ board-certified pathologists who have contributed 32.5M+ annotations to train and validate AI models.
Regulatory-Grade Compliance: AISight® Dx has received FDA 510(k) clearance and CE-IVDR marking; AIM-MASH is the first AI tool to receive FDA qualification for MASH clinical trials.

Use Cases

Biopharma companies using AI to accelerate biomarker discovery and drug development across oncology and inflammatory disease indications.
Anatomic pathology labs deploying AISight® to digitize and streamline case management, slide scanning, and AI-assisted diagnosis workflows.
Clinical trial sponsors integrating PathAI's AIM algorithms to establish standardized, reproducible histopathology endpoints for regulatory submissions.
Healthcare systems adopting FDA-cleared digital pathology platforms to enable remote pathology review and improve diagnostic throughput.
Research institutions leveraging PathAI's pathologist contributor network and annotated datasets to train and validate new AI models.

Pros

Trusted by Top Biopharma: 90% of the top 15 global biopharma companies leverage PathAI's technology, demonstrating deep industry credibility and adoption.
FDA-Cleared & Regulatory Ready: Multiple products have received FDA clearance and CE-IVDR marking, making PathAI suitable for clinical-grade and trial-grade applications.
Comprehensive AI Algorithm Library: Wide range of validated algorithms covering tumor detection, biomarker quantification, and disease-specific endpoints across oncology and beyond.

Cons

Enterprise-Only Pricing: PathAI is designed exclusively for enterprise biopharma and laboratory clients; there is no self-serve or SMB tier available.
Specialized Use Case: The platform is purpose-built for pathology and life sciences, limiting relevance to organizations outside of healthcare and biopharma.

Frequently Asked Questions

AISight® is a cloud-native digital pathology image management system that serves as a central hub for case management, image analysis, and AI-powered histopathology workflows. It is FDA 510(k) cleared and CE-IVDR marked.

PathAI serves biopharma companies, academic medical centers, reference laboratories, health systems, and clinical trial sponsors seeking to integrate AI into pathology workflows and drug development pipelines.

Yes. AISight® Dx has received FDA 510(k) clearance for primary diagnosis, and AIM-MASH is the first AI-powered tool to receive FDA qualification for MASH clinical trials.

PathAI offers a range of algorithms including TumorDetect, AIM-Tumor, AIM-PDL1, AIM-HER2, AIM-ER, AIM-PR, AIM-Ki67, AIM-MASH, METPredict, PathAssistDerm, and more for biomarker quantification and workflow automation.

PathAI provides AI-enabled clinical development services including standardized histopathology endpoints, companion diagnostics development, and real-world data solutions to support every phase of clinical trials.