The U.S. Food and Drug Administration has granted breakthrough device designation to Aidoc’s multi-triage CT tool delivered through the company’s aiOS enterprise operating platform. According to Aidoc, the Artificial Intelligence software enables parallel review of multiple indications and triages acute findings in CT scans, allowing clinicians to prioritize urgent cases. The system is built on the company’s clinical-grade foundation model CARE, short for Clinical Artificial Intelligence Reasoning Engine, and is aimed at tackling bottlenecks in emergency care by surfacing time-sensitive findings more quickly.
Aidoc framed the designation as a step toward a comprehensive, integrated clinical Artificial Intelligence package. The company said additional CARE-powered capabilities are in development, including automatic creation of draft reports intended to further streamline radiology workflows. While details on timing were not provided, the company positioned these features as part of a broader strategy to embed triage and reporting support within existing clinical systems via its aiOS platform.
In its announcement, Aidoc also highlighted its broader regulatory and deployment footprint. The company noted a total of 18 FDA clearances to date and said its software is installed across more than 150 U.S. health systems and over 1,600 hospitals worldwide. The breakthrough device designation adds to that track record, underscoring Aidoc’s push to expand its portfolio of triage and workflow tools that apply foundation model capabilities to CT imaging in high-acuity settings.
