The Food and Drug Administration has granted breakthrough designation to two devices that use generative AI to interpret chest X-rays and draft radiology reports.[1781981][1788707] Machine learning systems have long analyzed images like X-rays and CT scans, but large vision language models have ushered in a new capability: processing entire images and drafting findings for radiologists to review.[1781981] Generative AI can now process chest X-rays and draft reports, challenging traditional validation and regulatory frameworks.[1788707] Cognita, a startup founded by Stanford researcher, has been granted breakthrough designation for its generative AI tool, while Radiology AI company Aidoc announced its own designation for a life-threatening finding detection tool.[1781981]