PathAI receives FDA Breakthrough Designation for PathAssist Derm to enhance skin lesion analysis
PathAI's PathAssist Derm, designed to assist in analyzing skin lesion images, has received FDA Breakthrough Device Designation, aiming to support pathologists in managing skin cancer cases more effectively.
PathAI announced that the U.S. Food and Drug Administration (FDA) has 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.
PathAI also recently received 510(k) clearance for AISight Dx, the first digital pathology Image Management System (IMS) cleared by the FDA with an authorized Predetermined Change Control Plan (PCCP) and additionally received EMA and FDA qualification of AIM-MASH AI Assist as the first AI-powered pathology Drug Development Tool (DDT).
By leveraging advanced AI technology to support case assessment and workflow prioritization, PathAssist Derm is designed to help pathologists manage rising skin cancer caseloads while maintaining diagnostic rigor.
PathAssist Derm is For Research Use Only. Not for use in diagnostic procedures.
