Regulation
FDA grants breakthrough status to Aidoc’s AI radiology report system
The FDA has granted breakthrough device designation to Aidoc's First Read, an AI system that generates preliminary radiology report text from chest radiograph analysis. Breakthrough status expedites the FDA review pathway for devices addressing unmet clinical needs or offering significant advantages over existing alternatives.
The source
This brief is a MedIndexer summary of reporting by Medical Device Network. To read the full story, head to the source.
Read the full story at Medical Device Network