PathAI

PathAI is an AI-focused technology company dedicated to transforming pathology and improving patient outcomes through reliable, AI-powered precision pathology solutions. Founded in 2016, the company serves biopharma organizations, academic medical centers, reference laboratories, health systems, and clinicians by delivering tools that span biomarker discovery, drug development, clinical trials, and diagnostic workflows. PathAI's solutions are built on a foundation of more than 32.5 million annotations contributed by a proprietary network of over 450 board-certified pathologists, enabling rigorous training and validation of its AI-based models.

PathAI positions itself as the only AI-focused technology company offering comprehensive precision pathology solutions end-to-end — from wet lab services to algorithm deployment for clinical trials and diagnostic use. Its technology is leveraged by 90% of the top 15 biopharma companies globally, and its platforms have received multiple regulatory clearances and qualifications from the FDA and EMA.

Core Platform: AISight® Digital Pathology Solution

• AISight® is a cloud-native, intelligent enterprise workflow solution used by leading laboratories and research centers worldwide to power digital pathology workflows and AI applications.
• It serves as a central hub for case management, image management, and best-in-class artificial intelligence tools, enabling multiple histopathology use cases.
• AISight® Dx received FDA 510(k) clearance and CE Mark for use in primary diagnosis in clinical settings, with the most recent FDA clearance in 2025 including a Predetermined Change Control Plan (PCCP) to allow specific future enhancements without requiring new regulatory submissions.
• Labcorp has expanded its collaboration with PathAI to deploy the FDA-cleared AISight® digital pathology platform nationwide.
• In 2024, PathAI announced a strategic partnership with Quest Diagnostics, which included the sale of PathAI Diagnostics and licensing of the AISight platform.

BioPharma Services and AI Products

• PathAI uses AI-powered pathology to advance every phase of drug and diagnostic development for biopharma partners.
• The company operates an in-house CAP/CLIA-certified, GCLP histopathology lab built in 2022 to fully support end-to-end clinical trials for biopharma partners.
• PathAI launched over 20 AI products in 2023, including PathExplore™, expanding its suite of tools for research and clinical applications.
• AISight® Clinical Trials Platform was expanded with the launch of AIM-HI™ UC and IBDExplore™, providing standardized histopathology endpoints for clinical trials in ulcerative colitis and inflammatory bowel disease.
• AIM-MASH AI Assist became the first AI-powered tool to receive FDA qualification as a Drug Development Tool (DDT) for MASH clinical trials, and subsequently also received EMA qualification — marking a significant regulatory milestone for AI in pathology.
• The FDA granted Breakthrough Device Designation to PathAssist Derm, designed to analyze digital pathology whole slide images (WSIs) of skin lesions and aid pathologists in their diagnostic review.

Precision Pathology Network

• In 2025, PathAI launched the Precision Pathology Network (PPN), described as the first global network of digital anatomic pathology laboratories.
• The network is utilized by leading anatomic pathology institutions across academic medical centers, reference laboratories, health systems, and biopharma organizations.

Compliance, Certifications, and Regulatory Milestones

• PathAI received ISO 13485 certification and MDSAP compliance for its quality management system, as well as ISO 27001 certification — one of the highest internationally recognized standards for information security management systems — both achieved in 2019.
• The company has been issued multiple patents, including patents covering prediction of patient survival time and tissue characteristics from pathology images.
• PathAI has published peer-reviewed research in leading journals including the Journal of Clinical Oncology and Hepatology, and has presented at major scientific conferences such as ASCO.

Pathologist Contributor Network and Team

• PathAI maintains a proprietary pathologist contributor network of over 450 board-certified pathologists who provide pathology interpretation services for research and development efforts.
• The company actively recruits board-certified, US-based pathologists with strong surgical pathology skills to join its contributor network.
• PathAI's leadership team brings expertise across engineering, machine learning, life sciences, medicine, regulatory affairs, strategy, and operations, and is led by Co-founder and CEO Andy Beck, MD, PhD, alongside a team including a Chief Medical Officer, Chief Financial Officer, Chief People Officer, Chief Growth Officer, and General Counsel.

Since its founding in 2016, PathAI has grown into a comprehensive precision pathology company with a clear mission: enabling more accurate diagnosis, better patient-treatment matching, and faster approval of life-saving therapies through the power of artificial intelligence applied to pathology.