FDA clears the first foundation-model-powered clinical AI, Aidoc's CARE1, for rib fracture triage

The Lazaretto keeps its watch on the water-world’s medicine.

On February 18, 2025, Aidoc announced FDA clearance for a computer-aided triage solution built on its CARE1 Foundation Model (Clinical AI Reasoning Engine, Version 1). The company described it as the first qualified foundation-model software as a medical device to be cleared by the FDA. The cleared application flags suspected rib fractures on imaging to help prioritize radiology worklists.

Unlike single-purpose detection tools trained for one finding, a foundation model is trained broadly and then adapted to many tasks. Aidoc said the approach is meant to let it develop and refine clinical AI across conditions more quickly and with greater robustness. The work is supported by a collaboration with Amazon Web Services.

The clearance is part of a rapid expansion of FDA-authorized artificial intelligence in medicine. Radiology accounts for the large majority of AI-enabled devices the agency has cleared to date, and the arrival of a foundation-model approach signals a shift from narrow, task-specific tools toward systems intended to serve many clinical uses from a shared base.