FDA gives breakthrough status to Aidoc AI that drafts chest X-ray reports
On June 25, 2026, Aidoc said the FDA granted Breakthrough Device Designation to First Read, software that analyzes chest radiographs and writes a draft radiology report for a radiologist to review and sign. The designation covers four life-threatening findings, and the company says the tool is designed to report on more than 100 findings. It is built on Aidoc's CARE foundation model. Breakthrough designation speeds up FDA review but is not a clearance, and First Read is not yet on the market. It is Aidoc's second breakthrough designation in under a year.
Why it's notable: This is one of the first AI tools meant to write the radiology report itself, not just flag a finding, to enter an expedited FDA pathway. That points to how imaging backlogs and report turnaround times may be handled.