PathAI has received a breakthrough device designation from the US Food and Drug Administration (FDA) for PathAssist Derm, an AI-powered dermatopathology workflow solution.
PathAssist Derm is designed to assess digital pathology whole slide images of skin lesions and assist pathologists during their review process.
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This latest regulatory milestone follows previous achievements for PathAI, which recently secured 510(k) clearance for AISight Dx, the first digital pathology image management system approved by the FDA with an authorised Predetermined Change Control Plan.
The company also received European Medicines Agency (EMA) and FDA qualification of AIM-MASH AI Assist as the first AI-driven pathology drug development tool.
PathAI’s CEO Dr Andy Beck said: “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.
“By working closely with the FDA through the breakthrough devices programme, we aim to accelerate the development and review process, ensuring that this transformative technology reaches pathologists and patients as quickly as possible.”
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By GlobalDataThe need for advanced solutions in dermatopathology is driven by rising rates of skin cancer in the US. Significant inter-observer variability complicates diagnosis, particularly for melanocytic lesions.
A study of pathologists found that accuracy and inter-observer concordance were below 50% for diagnostically challenging lesion classes.
PathAssist Derm utilises AI to support case assessment and workflow prioritisation, addressing these challenges while assisting pathologists in managing increasing caseloads responsibly.
The company will continue working alongside global regulators to advance AI-powered pathology solutions aimed at strengthening diagnostic confidence and supporting patient care.
In February 2025, PathAI launched the PathAssist Derm AI tool, designed for orienting, detecting, and measuring skin lesions. It is available on the AISight image management system.
