Aidoc Secures Landmark FDA Clearance for First Foundation Model-Powered Clinical AI Solution of Its Kind

FDA clearance of AI solution powered by groundbreaking technology - the CARE1™ Foundation Model sets a new benchmark in healthcare AI, the first QFM SaMD device powered by this technology

NEW YORK, Feb. 18, 2025 /PRNewswire/ -- Aidoc, a global leader in clinical AI, has secured a defining FDA clearance for a CADt AI solution powered by a foundation model — a major step forward in the evolution of clinical AI. This milestone reinforces the growing role of foundation models as a transformative force, enabling faster development, potentially greater accuracy and more scalable AI solutions that drive real-world clinical impact.

This clearance applies to Aidoc's Rib Fractures triage solution, a new version built on Aidoc's CARE1™ Foundation Model (Clinical AI Reasoning Engine, Version 1). This clearance demonstrates how foundation models can enhance existing solutions and expand AI's clinical utility. Although foundation models require vast resources and extensive datasets to develop, they dramatically accelerate AI development and adoption, shrinking innovation timelines from years to weeks.

"A year ago, what we're seeing today seemed impossible. Now, it's happening faster than anyone expected," said Michael Braginsky, CTO, Aidoc. "Every major organization will soon have to decide: build a foundation model or leverage one. As this shift accelerates, the real differentiator will be accuracy. Only the most accurate models will drive real impact."

This milestone comes as Aidoc enters its third year of foundation model research, backed by a strategic collaboration with Amazon Web Services (AWS). Through this multi-year agreement, AWS is providing significant investment to enhance Aidoc's aiOS™ platform, as well as the CARE™ Foundation Model technology, delivered on top of it together with AI modules by additional vendors. Aidoc is already working on the next version of the foundation model, CARE2™, that is planned to be released in the upcoming months.

Advancing Clinical AI with the Power of Foundation Models

Unlike traditional AI models designed for single-use cases, the CARE1™ Foundation Model is built for scalability, allowing Aidoc to develop and refine AI solutions faster while ensuring greater clinical robustness. By leveraging a vast and diverse dataset, CARE1™ enables potentially higher accuracy, improved generalizability and faster adaptation to new medical challenges. This clearance is a proof point that foundation models are no longer just an emerging concept, but they can be converted into clinically viable devices.

"We partnered with Aidoc because they align with our enterprise vision and mission of better patient care," said Joe Kelly, Chief Transformation Officer, Mercy. "First, their seamless integration into clinical practice enhances daily decision-making for the benefit of our patients. Second, their pace of innovation matches ours—we wanted to move fast, and this latest milestone affirms that Aidoc is a partner that can scale with us and support our organization-wide strategy. Mercy deployed Aidoc's suite of tools earlier this month at an enterprise scale, ensuring all of our patients, regardless of location, benefit from the latest technological advancements in care."

"This isn't just an upgrade, it's a paradigm shift," said Reut Yalon, PhD, Chief Product Officer, Aidoc. "Our goal is twofold: continuously enhance existing solutions with this new technology while simultaneously pushing AI into new frontiers and expanding coverage across a broader range of conditions. This clearance is just the beginning."

Foundation models lead hospitals to adopt AI at an unprecedented pace, but fragmented solutions create inefficiencies. Without a unified platform for integration, deployment and monitoring, scaling AI will lead to operational bottlenecks.

"The future of AI goes beyond simply creating smarter models—it's about seamlessly integrating, scaling and delivering these innovations to end users," said Braginsky. "Our aiOS™ platform offers a single point for integration, orchestration, monitoring and governance. As AI model development accelerates, managing the resulting complexity becomes critical; without proper controls, rapid growth could overwhelm the health systems. Our robust infrastructure lays the foundation for transformation, empowering medical professionals to set new standards of care while boosting efficiency."

For more information about CARE1™, Aidoc's integrated approach and the future of clinical AI, visit www.aidoc.com.

About Aidoc

Aidoc is a pioneering force in clinical AI. We focus on aiding and empowering healthcare teams to optimize patient treatment, which results in improved economic value and clinical outcomes. Built on Aidoc's proprietary aiOS™, we analyze and aggregate medical data to enable care teams to operationalize the unexpected and work seamlessly with a continued focus on the patient. Used in over 1,500 medical centers worldwide, Aidoc leads the clinical AI industry with over 20 FDA clearances, empowering physicians to make more informed decisions with real-time data. Visit Aidoc.com to see how we are connecting all points of care with always on AI.

Logo - https://mma.prnewswire.com/media/2015772/5171475/Aidoc_Always_On_AI_Logo.jpg

SOURCE Aidoc