FDA Grants Breakthrough Designation to Two Generative AIs for Radiology

Cognita and Aidoc's tools, which can interpret chest X-rays and write reports, have been granted the FDA's "Breakthrough Device" designation.

The FDA has granted Breakthrough Device Designation to Cognita's and Aidoc's generative AI solutions, both of which are designed to analyze chest X-rays and automatically produce a preliminary X-ray report. One of the goals of Aidoc's First Read tool is to relieve overcrowding in imaging departments, where demand far exceeds available human interpretation capabilities.

This announcement is part of a broader dynamic: radiology alone concentrates more than three-quarters of the AI algorithms already validated by the FDA in the United States.