The Food and Drug Administration has granted breakthrough designation to two devices that use generative AI to interpret chest X-rays and draft the radiology reports typically written by human radiologists.
Machine learning systems have long analyzed images like X-rays and CT scans. But more recently, large vision language models have ushered in a new capability. Instead of highlighting a spot for a radiologist to review and write up, generative AI can process the entire image and draft many of its findings for a radiologist to review — a technological advancement that is challenging traditional validation and regulatory frameworks.
In March, one breakthrough designation went to Cognita, a Stanford researcher-founded startup acquired late last year by the large radiology practice Radiology Partners. Radiology AI company Aidoc announced its own breakthrough designation Thursday for a tool called First Read, specifically when it is used to detect and describe four life-threatening findings.
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