The FDA has granted Breakthrough Device Designation to two generative AI platforms designed to draft radiology reports from chest X-rays, signaling growing federal recognition of AI as a tool to address the radiologist shortage.
Aidoc, a clinical AI company supporting diagnostic decisions across nearly 2,000 hospitals worldwide, received the designation for its First Read platform, according to a June 25 news release. The platform analyzes chest radiographs and generates preliminary draft report text, aiming to reduce time radiologists spend on reporting and return capacity for higher-value clinical work.
Mosaic Clinical Technologies, a wholly owned subsidiary of Radiology Partners, received the same designation in March for Cognita Chest X-Ray, a generative vision-language model that interprets chest X-rays and drafts preliminary findings for radiologist review, according to a March 5 news release. The platform generates comprehensive integrated findings directly within existing radiology workflows, and early results showed participating radiologists achieved enhanced detection of up to 16% to 65% for certain significant findings and an 18% boost in average interpretation efficiency.
Both designations come as imaging demand continues to outpace workforce supply — and as some health system leaders have begun asking how far AI could go in absorbing that load. A February 2026 Neiman Health Policy Institute update found the shortage is projected to remain static through 2055 without intervention, with workforce attrition rates having more than doubled between 2014 and 2022.
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