Aidoc Files Breakthrough FDA Submission for Foundation Model Covering Double-Digit Conditions

FDA multi-triage AI submission^[1] follows Aidoc aiOS™ surpassing 100 million analyzed patient cases, confirming the operating system needed to scale foundation-model AI safely

NEW YORK, Nov. 25, 2025 /PRNewswire/ -- Aidoc, the global leader in clinical AI with the most FDA-cleared CAD solutions, today announced a major milestone: the completion of its pivotal study and FDA submission for its breakthrough-designated multi-triage device, powered by the CARE™ Foundation Model, designed to detect and prioritize double-digit abdominal conditions within a single solution. This clinical achievement comes as Aidoc aiOS™ (AI Operating System) surpasses 100 million analyzed patient cases - the largest real-world clinical AI footprint in healthcare. Together, CARE and aiOS signal the next step in scaling foundation-model clinical AI safely and reliably across health systems worldwide. In the pivotal study, Aidoc's CARE-powered multi-triage solution demonstrated high levels of accuracy across a wide range of abdominal findings^[2]:

• 97% sensitivity (up to 98.5% at maximum sensitivity)
• 98% specificity (up to 99.7% at maximum specificity)

"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."

The always-on triage system identifies cases with acute, time-sensitive abnormalities moments after scan completion, supporting radiologists with near real-time insights while keeping cognitive load low. After securing the industry's first FDA clearances for foundation model-based solutions, this multi-condition clinical AI solution marks the next significant step.

As the FDA submission is under review, aiOS continues to provide the proven operating system for safe, real-world scale of clinical AI. With more than 100 million patient cases analyzed, aiOS is the largest clinical AI deployment in healthcare, powering, stabilizing, and continuously monitoring every AI model on it. While individual models often receive the attention, the operating system underlying them determines whether clinicians experience accuracy, reliability, and trust at scale. This is what turns CARE's breakthrough performance into daily clinical impact through unified workflows, real-world data alignment, reliable performance in any clinical setting, and AI-powered analytics.

"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."

Key capabilities of Aidoc aiOS include precision orchestration tailored to each hospital, modality, and physician workflow, continuous drift monitoring, and real-time multimodal data integration for a complete clinical picture.

Aidoc will be talking about CARE, aiOS, and the latest clinical AI innovations at the 2025 Radiological Society of North America (RSNA) annual meeting, on Nov. 30 - Dec. 4 at McCormick Place in Chicago. Visit Aidoc in South Hall Booth #4741 to connect with clinical and technology experts, experience live demonstrations, and learn firsthand how leading health systems are deploying AI at scale.

^{[1] The device received breakthrough device designation by FDA, and is now under FDA review and 510(k) pending, not currently available for sale in the U.S.
[2] Mean sensitivity and specificity across all indications as calculated in the pivotal study.}

About Aidoc

Aidoc powers clinical decisions for more than 60 million patients a year, delivering real-time clinical AI that eases cognitive load, boosts productivity, and elevates care across imaging and clinical data. Built on the proprietary aiOS, Aidoc integrates seamlessly into provider workflows at the point of care, helping clinicians prioritize faster and decide with greater confidence. With the most FDA-cleared CAD solutions in clinical AI and adoption in more than 1,600 medical centers worldwide, Aidoc strengthens the physician and patient experience.

See how we are setting a new standard for clinical AI at www.aidoc.com.

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