
PathAI
About PathAI
PathAI launched the Precision Pathology Network(PPN) , the first global network of digital anatomic pathology laboratories.
2025 - AISight® Dx Received FDA Clearance PathAI received FDA clearance for the evolved AISight® Dx digital pathology platform for primary diagnosis, including a Predetermined Change Control Plan (PCCP) to enable specific future enhancements without new submissions.
2025 - AIM-MASH AI Assist Expanded Regulatory Qualification PathAI received EMA and FDA qualification of AIM-MASH AI Assist as the first AI-powered pathology Drug Development Tool (DDT).
2026 - Breakthrough Device Designation for PathAssist Derm 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 review
