Modella AI: Generative AI Co-Pilot PathChat Receives FDA Breakthrough Device Designation
BOSTON–(BUSINESS WIRE)–Modella AI, a pioneer in generative and agentic artificial intelligence for biomedicine, is proud to announce that its cutting-edge generative AI co-pilot, PathChat DX, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This recognition underscores PathChat DX’s potential to transform diagnostic workflows and improve patient outcomes in pathology.
The FDA’s Breakthrough Device Designation is reserved for medical devices that offer significant advantages over existing standards of care, addressing unmet medical needs or providing critical advancements in healthcare. PathChat DX, which is an extension of the PathChat model recently published in Nature and developed in the Mahmood Lab, led by Faisal Mahmood, PhD at Mass General Brigham. PathChat integrates advanced generative AI and multimodal analysis which are designed to assist pathologists in diagnosing complex cases with greater accuracy and efficiency. PathChat leverages a unique combination of pathology foundation models, pretrained on extensive histology image and image-text datasets, and a custom trained multimodal large language model (MLLM) to analyze high-resolution pathology images and clinical data.
With this designation, Modella AI will benefit from prioritized FDA review and increased collaboration with the agency, expediting the development and commercialization process for PathChat DX. The designation highlights the FDA’s recognition of the platform’s potential to address critical challenges in pathology, including diagnostic variability and increasing case volumes.
“The Breakthrough Device Designation is a testament to the transformative potential of PathChat DX as one of the first generative AI tools specifically trained for human pathology,” said Dr. Jill Stefanelli, CEO of Modella AI. “This milestone brings us closer to our mission of using generative and agentic AI to accelerate diagnostic workflows.”
“PathChat DX represents a transformative step forward for pathologists at every stage of their career. By enhancing diagnostic precision and potentially accelerating the time to diagnosis, it addresses critical needs in patient care, where timely and accurate decisions directly impact treatment outcomes,” said Alexander Lazar MD, PhD, Professor & Surgical Pathologist at The University of Texas MD Anderson Cancer Center and Scientific Advisor to Modella AI. “With the rising demands and challenges in pathology, including growing workloads and burnout, tools like PathChat DX offer an opportunity to help pathologists improve both their efficiency and resilience in our complex field.”
About Modella AI
Modella AI (www.modella.ai) is a Boston-based biomedical AI company dedicated to advancing healthcare through the development of cutting-edge generative and agentic AI technologies. By combining expertise in artificial intelligence and pathology, Modella AI aims to deliver innovative solutions that empower clinicians, improve patient outcomes, and transform medical workflows.
Disclaimer: The FDA Breakthrough Device Designation does not imply FDA clearance or approval. PathChat DX is currently undergoing further testing and evaluation to ensure compliance with regulatory standards and clinical safety requirements. This release may contain forward-looking statements based on current assumptions and forecasts made by Modella AI management. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
