Israeli medtech startup Aidoc has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its groundbreaking multi-triage AI solution that can simultaneously flag a wide array of life-threatening, time-sensitive medical conditions within a single workflow. This marks the first-ever FDA designation for artificial intelligence technology with such broad coverage of medical conditions under one solution.
The system is built on CARE (Clinical AI Reasoning Engine), which Aidoc describes as the first clinical-grade foundation model in healthcare with FDA cleared solutions. Deployed through Aidoc's aiOS platform, the technology is designed to help care teams attend to high-risk cases faster and more consistently across health systems.
Addressing Critical Healthcare Bottlenecks
Emergency departments and inpatient units face mounting pressure from rising patient volumes and worsening physician and nurse shortages. According to the company, median visit times in U.S. emergency departments now exceed 160 minutes, representing the longest wait times in more than a decade. In 2024, over one in four admitted patients waited four or more hours for a bed, with many waiting beyond 24 hours.
Radiology departments are particularly strained, with escalating imaging demand pushing facilities to their limits and creating delays that cascade downstream. Aidoc's comprehensive AI-powered triage system aims to break this cycle by flagging urgent cases and streamlining workflows to restore flow across emergency departments.
"With this designation and our ecosystem of specialized partners, we can deliver a broader set of solutions across many service lines," said Elad Walach, co-founder and CEO of Aidoc. "CARE's ability to detect, characterize, measure, and compare findings underpins both current and in-development applications from triage to report drafting."
Revolutionary Multi-Indication Approach
The FDA grants Breakthrough Device Designation to technologies that both significantly advance the diagnosis of severe diseases and represent an unmet clinical need. The designation is intended to accelerate access to life-saving innovations by expediting the review process.
Historically, Aidoc expanded its FDA-cleared offerings one condition at a time. CARE represents a fundamental shift by enabling broad, simultaneous coverage across many pathologies. The new designation allows parallel FDA review of double-digit indications within a single submission, an important step toward bringing comprehensive, high-accuracy clinical AI to routine care while maintaining robust safety and effectiveness standards.
"This Breakthrough Designation is a powerful validation of our CARE foundation model and its ability to change the way technology enables quality care," Walach stated. "The new technology means our mission is at hand - to support physicians in every patient encounter."
Technical Innovation and Implementation
CARE is specifically designed for clinical use and trained on an enormous amount of real-world multimodal data to safely expand across diseases and care settings. Along with aiOS, Aidoc's enterprise platform, health systems can integrate AI into existing workflows, manage performance, and deploy both Aidoc and third-party AI models across various service lines.
Michael Braginsky, co-founder and CTO of Aidoc, emphasized the complexity of implementation: "The technology creates an extraordinary opportunity to advance healthcare, but success depends on more than the AI itself. 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."
Market Impact and Future Development
Aidoc has established itself as a leader in clinical AI, with 18 FDA clearances and deployments across over 150 U.S. health systems and more than 1,600 hospitals worldwide. The company assists physicians in clinical decisions for over 45 million patients annually and has secured collaborations with Nvidia and AWS, with over $150 million committed to CARE's development and deployment.
The Breakthrough milestone advances Aidoc's roadmap toward a comprehensive, integrated clinical AI package, with additional CARE-powered capabilities such as auto-creation of draft reports already in development. Clearance for multi-use systems covering tens of pathologies represents a complex and unprecedented regulatory challenge, prompting renewed attention to design, development, and validation frameworks in the clinical AI space.
