AI pathology firm PathAI has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to PathAssist Derm, designed to analyse digital pathology whole slide images (WSIs) of skin lesions and aid pathologists in their review.
According to the American Cancer Society, skin cancer is the most commonly diagnosed cancer in the United States, placing increasing demand on pathology services. Dermatopathology is further complicated by substantial inter-observer variability, particularly in melanocytic lesions; as documented in a large study of pathologists that found both inter-observer concordance and accuracy compared to a consensus reference diagnosis, were below 50% for diagnostically challenging lesion classes. By leveraging advanced AI technology to support case assessment and workflow prioritisation, PathAssist Derm is designed to help pathologists manage rising caseloads while maintaining diagnostic rigor.
"This designation is a powerful acknowledgement of our AI capabilities and our commitment to bringing rigorously validated, clinically relevant tools to the field of digital pathology," said Dr. Andy Beck, CEO at PathAI. "By working closely with the FDA through the Breakthrough Devices Program, we aim to accelerate the development and review process, ensuring that this transformative technology reaches pathologists and patients as quickly as possible."
This Breakthrough Device Designation represents the latest in a series of regulatory achievements for PathAI. The company recently received 510(k) clearance for AISight Dx, the first digital pathology Image Management System (IMS) cleared by the FDA with an authorised 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.
PathAssist Derm is for research use only, not for use in diagnostic procedures.