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

The FDA has granted breakthrough designation to two specific devices utilizing generative AI to interpret chest X-rays and draft corresponding radiology reports. This development occurs as the FDA breakthrough pipeline continues to fill with various generative AI devices. Additionally, the agency has dropped enforcement actions against Whoop. These updates highlight the increasing integration of AI technologies within medical imaging and health monitoring, as more devices receive the official breakthrough label from the regulatory body.