The U.S. Food and Drug Administration has granted breakthrough designation to two devices that use generative AI to interpret chest X-rays and automate radiology report drafting, according to STAT News. The move marks a significant regulatory nod for AI in clinical imaging.
This development comes amid a broader uptick in FDA breakthrough designations for generative AI medical devices. The agency's pipeline is increasingly filled with such tools, reflecting a growing acceptance of AI's role in diagnostics.
The breakthrough designation is not an approval but expedites development and review. The devices—from firms Cognita and Aidoc—must still clear clinical validation hurdles before coming to market.
If successful, these tools could alleviate radiologist workloads and reduce diagnostic delays. But questions remain about liability and accuracy when AI generates clinical text without direct human oversight.
The FDA has not released specific performance data for these devices. Critics warn that generative AI in radiology risks amplifying errors if not rigorously tested in real-world settings.