PathAI Receives U.S. FDA Breakthrough Device Designation for PathAssist Derm, an AI-Powered Pathology Solution to Transform Dermatopathology Workflow

BOSTON, March 03, 2026 (GLOBE NEWSWIRE) -- PathAI, Inc., a global leader in artificial intelligence (AI)-powered pathology solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to PathAssist Derm¹, designed to analyze digital pathology whole slide images (WSIs) of skin lesions and aid pathologists in their review.

This Breakthrough Device Designation represents the latest in a series of regulatory achievements for PathAI. The company recently received 510(k) clearance for AISight® Dx², 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 Assist³ as the first AI-powered pathology Drug Development Tool (DDT).

"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".

Addressing Critical Challenges in Dermatopathology

Skin cancer is the most commonly diagnosed cancer in the United States⁴, 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 classes⁵. By leveraging advanced AI technology to support case assessment and workflow prioritization, PathAssist Derm is designed to help pathologists manage rising caseloads while maintaining diagnostic rigor.

The company will continue to partner with global regulators to advance AI-powered solutions that strengthen diagnostic confidence and improve patient care.

References

1. PathAssist Derm is For Research Use Only. Not for use in diagnostic procedures.
2. AISight® Dx is FDA-cleared for primary diagnosis in the US, and is CE‑IVD–marked for primary diagnosis in the EEA, UK, and Switzerland.
3. AIM-MASH AI Assist is qualified as a tool in the EU and as a DDT in the US for use in MASH clinical trials. AIM-MASH AI Assist is not for use in diagnostic procedures.
4. American Cancer Society. Cancer Facts & Figures 2025. Atlanta: American Cancer Society; 2025.
5. Elmore JG, et al. Pathologists’ diagnosis of invasive melanoma and melanocytic proliferations: observer accuracy and reproducibility study. BMJ. 2017;357:j2813
   
   

About PathAI
PathAI is a leading provider of AI-powered pathology solutions that aim to improve the accuracy of histology assessment and accelerate drug development. PathAI's platform leverages advanced artificial intelligence to analyze and interpret pathology images, providing valuable insights to pathologists, researchers, and pharmaceutical companies. PathAI is headquartered in Boston, MA. For more information, please visit www.pathai.com and follow us on LinkedIn.

Company Contact
Liz Storti
Chief People Officer
elizabeth.storti@pathai.com

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LifeSci Communications
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