Aidoc announced its completion of a pivotal study for its multi-triage device, powered by the CARE Foundation Model, designed to detect and prioritize double-digit abdominal conditions within a single solution.¹

Following completion of this study, Aidoc submitted its CARE-powered breakthrough-designated device for FDA approval after the device displayed high levels of accuracy in a wide range of abdominal findings.¹

"Broad foundation models are the path to expanding clinical AI across care delivery, but only if we raise the safety and quality bar beyond anything the field has seen," said Elad Walach, CEO and co-founder of Aidoc. "Accuracy that works for one finding won't hold for many. CARE delivers precision that limits false positives and elevates only what matters, avoiding the noise that has hindered physician adoption. Built for broad, real-world practice, this submission positions Aidoc for a historic first in presumably the most comprehensive CAD."

What is Aidoc’s CARE-powered multi-triage device?

Aidoc’s always-on triage device identifies cases of acute, time-sensitive abnormalities following scan completion and supports radiologists with nearly real-time insights, keeping cognitive load low.¹

The device marks a signification step in using multi-condition clinical AI solutions as a treatment option and, as noted, marks an historical approval of the first foundation model-based solution.¹

An additional milestone

Aidoc also announced that its aiOS, the company’s AI operating system, surpassed 100 million patient case analyses.¹

The capabilities of the aiOS system include:

• Precision orchestration specifically designed for each hospital
• Modality
• Physician workflow
• Continuous drift monitoring
• Real-time multimodal data integration for a complete clinical picture.

According to Aidoc, surpassing 100 million patient cases marked aiOS as the largest clinical AI deployment in healthcare. aiOS, the company believes, underlies the importance of a reliable, safe, and innovative operating system and determining whether clinicians experience accuracy, reliability, and trust at scale.¹ These factors impact CARE's daily performance, directing it to clinical impacts through unified workflows and real-world data alignment.¹

"Patient safety and timely care are at the heart of everything we do," said Neal Patel, MD, MPH, chief health information officer at Vanderbilt University Medical Center. "aiOS allows us to integrate clinical AI safely and at scale. It's not just strong AI models, it's the orchestration, workflow intelligence, and performance tracking behind them. This empowers our care teams to routinely deliver the right care at the right time. Every health system should have this capability, and our partnership with Aidoc is making that possible for us."

Sources

1. Aidoc Files Breakthrough FDA Submission for Foundation Model Covering Double-Digit Conditions. Aidoc. November 25, 2025 https://www.prnewswire.com/news-releases/aidoc-files-breakthrough-fda-submission-for-foundation-model-covering-double-digit-conditions-302625623.html

2. Aidoc Receives FDA Breakthrough Device Designation for First-of-Kind AI Solution Spanning Numerous Acute Conditions in CT. Aidoc. November 25, 2025 https://www.aidoc.com/about/news/aidoc-receives-fda-breakthrough-device-designation/