The FDA has granted breakthrough designation to two generative AI devices designed to interpret chest X-rays and draft radiology reports, marking significant advancements in medical imaging technology. These devices, developed by Cognita and Aidoc, represent a shift from traditional radiology practices, wherein human radiologists typically analyze images and produce written reports. With the ability to comprehensively assess images and summarize findings, these AI tools are set to challenge existing validation and regulatory frameworks in the healthcare sector.
Thu, 25 Jun 2026 12:17:13 GMT | statnews.com