MODELLA AI'S GENERATIVE AI CO-PILOT PATHCHAT RECEIVES FDA BREAKTHROUGH DEVICE DESIGNATION

BOSTON, Jan 31 (Bernama) -- 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.