STAT+: FDA gives generative AI in radiology two breakthrough designation nods

The Food and Drug Administration (FDA) granted breakthrough designation to two generative AI devices designed to interpret chest X-rays and draft radiology reports on March 14, 2024. These systems represent an advancement beyond traditional machine learning, which has analyzed medical images for years. Large vision language models now enable generative AI to process entire images and draft findings for radiologist review, presenting new challenges for regulatory validation. One designation was awarded to Cognita, a startup founded by Stanford researchers and acquired by Radiology Partners. Aidoc, a radiology AI company, also received a breakthrough designation for its tool, First Read, which is specifically designed to detect and describe four life-threatening conditions in X-rays.