The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Aidoc's multi-triage CT tool deployed through an aiOS enterprise operating platform.
Aidoc said the AI triage tool enables parallel review of multiple indications and triages acute findings in CT scans. Built on the company’s clinical-grade foundation model CARE (Clinical AI Reasoning Engine), the software is designed to flag urgent cases and addresses bottlenecks in emergency care, according to Aidoc.
The achievement advances Aidoc’s path toward a comprehensive, integrated clinical AI package, with additional CARE‑powered capabilities such as auto‑creation of draft reports already in development, the company said.
In its announcement, Aidoc noted that it has secured 18 FDA clearances overall, and that its software has been deployed in over 150 U.S. health systems and more than 1,600 hospitals worldwide.
