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.<\/p>\n
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 \u2014 a technological advancement that is challenging traditional validation and regulatory frameworks.\u00a0<\/p>\n
In March, one breakthrough designation went to Cognita, a Stanford researcher-founded startup acquired<\/a> 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.\u00a0<\/p>\n STAT+ Exclusive Story<\/p>\n Already have an account? Log in<\/a><\/p>\n \t\t\t \t\t\t\t\t \t\t\t\tThis article is exclusive to STAT+ subscribers Already have an account? Log in<\/a><\/p>\n \t\t\t\t\t\tIndividual plans<\/p>\n \t\t\t\t\t\tGroup plans<\/p>\n![\"STAT+\"\/](\"https:\/\/www.newsbeep.com\/us\/wp-content\/uploads\/2025\/12\/1765280600_844_stat-plus-breaker-bg.png\")
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