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.
![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
