Aidoc

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Chest X-ray AI that drafts radiology reports wins FDA breakthrough designation

As of September 2026: Received breakthrough designation for First Read in June 2026; tool remains investigational and not cleared or approved

The Food and Drug Administration granted breakthrough-device status to Cognita CXR, a generative AI model that reads chest X-rays and drafts the preliminary report a radiologist then reviews. It's the first generative model in radiology to get the designation; Aidoc's rival tool, First Read, followed in June.

Updated Sep 6

AI systems advance toward autonomous medical diagnosis

New Capabilities

As of June 2026: Developer of CARE clinical foundation model; raised $150M Series E in April 2026, bringing total funding to over $500M; holds 31 FDA-cleared radiology devices

University of Michigan researchers published Prima in February 2026, an AI that reads brain MRIs in seconds with up to 97.5% accuracy across 50 neurological conditions. In April 2026, Harvard Medical School reported that OpenAI's o1 model correctly diagnosed emergency patients 67% of the time, compared to 50–55% for two attending physicians reviewing the same cases.

Updated Jun 24