Aidoc Earns FDA Breakthrough Device Designation for Multi-Condition Clinical AI Platform

Aidoc, a global leader in healthcare artificial intelligence, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its pioneering multi-triage AI solution capable of detecting numerous life-threatening, time-sensitive medical conditions within a single workflow. Built on CARE™, the first clinical-grade foundation model in healthcare, and deployed through the company’s aiOS™ platform, the technology is designed to help clinicians identify and prioritize high-risk cases more rapidly and consistently across entire health systems.

This marks the first time the FDA has granted such a designation to an AI system covering such a broad spectrum of medical conditions. The Breakthrough Device program recognizes technologies that significantly enhance disease diagnosis and address unmet medical needs, enabling faster access to critical innovations. In Aidoc’s case, the designation allows for parallel review of multiple clinical indications within one submission, a major step toward establishing comprehensive, high-accuracy AI as a standard element of patient care—while maintaining the FDA’s rigorous safety and efficacy requirements.

“With this designation and our ecosystem of specialized partners, we can deliver a broader set of solutions across many service lines,” said Elad Walach, Aidoc’s co-founder and CEO. “CARE’s ability to detect, characterize, measure, and compare findings underpins both current and in-development applications—from triage to report drafting. We are tackling this from multiple angles, developing innovations in parallel and, as each is FDA cleared, bringing it to market—delivering valuable, safe solutions while building toward the next milestone.”

The need for such innovation has never been greater. Emergency departments and inpatient units face surging patient volumes, coupled with persistent shortages of clinicians and nurses. Radiology departments, central to diagnosis and treatment planning, are especially strained as imaging demand continues to rise. These pressures create systemic delays—by 2024, more than one in four admitted patients waited four or more hours for a bed, with many waiting over 24 hours—undermining both patient outcomes and staff efficiency. Aidoc’s AI-driven triage technology is designed to break this bottleneck by identifying urgent cases early, streamlining radiology workflows, and accelerating patient throughput across departments.

Aidoc already holds the most FDA-cleared AI indications in its field, with its solutions deployed across more than 150 U.S. health systems and 1,600 hospitals globally. Traditionally, these approvals have been secured one condition at a time. The CARE model, however, enables simultaneous coverage of dozens of pathologies—an unprecedented shift that demands new frameworks for AI validation and integration.

“The technology creates an extraordinary opportunity to advance healthcare, but success depends on more than the AI itself,” said Michael Braginsky, Aidoc’s co-founder and CTO. “It’s about how it integrates, what data it can access, how it interacts with users, and how change is managed—ultimately ensuring patients are treated faster and better. It’s a massive lift, but by leveraging the expertise and infrastructure we’ve built over the years, we’re turning this vision into reality.”

At the heart of the system, CARE™ (Clinical AI Reasoning Engine) is trained on vast multimodal, real-world datasets and designed specifically for clinical deployment. Integrated with aiOS™, Aidoc’s enterprise AI operating platform, health systems can seamlessly embed the technology into existing workflows, monitor performance, and deploy both Aidoc’s and third-party AI models across multiple service lines.

The Breakthrough Designation propels Aidoc closer to its goal of offering a comprehensive, fully integrated clinical AI ecosystem. Future expansions will include CARE-powered tools for automated report drafting and broader clinical support capabilities. With 18 FDA clearances, strategic collaborations with Nvidia and AWS, and over $150 million invested in CARE’s ongoing development, Aidoc continues to shape the frontier of AI-driven patient care.