The FDA just fast-tracked two AI tools that write radiology reports from scratch - and the legal, liability, and reimbursement frameworks are not ready.
A chest X-ray lands in a radiologist's queue. Before they open it, an AI has already reviewed the image and written a preliminary report. The radiologist reads it, corrects it, and signs. The whole interaction takes 25 seconds.
That is not a thought experiment. That is what Aidoc's First Read system - now holding FDA Breakthrough Device Designation - is designed to do. And a second company, Mosaic Clinical Technologies' Cognita, received the same designation earlier this year. Two generative AI radiology tools. Both with the FDA's fastest review track. Both targeting chest X-rays. Both capable of drafting the actual report text - not just flagging findings.
This is a categorical shift. For the last decade, radiology AI has been about detection: flag the nodule, highlight the hemorrhage, triage the critical case. Now the technology is cro…
