Aidoc Receives FDA Breakthrough Device Designation for First-of-Kind AI Solution Spanning Numerous Acute Conditions in CT

Powered by CARE™ - the first clinical-grade foundation model in healthcare with FDA cleared solutions, built to solve one of the most critical bottlenecks in health systems

NEW YORK, Sept. 30, 2025 /PRNewswire/ -- Aidoc, the global leader in clinical AI, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company's novel multi-triage solution that flags a wide array of life-threatening, time-sensitive medical conditions, all within a single workflow. Built on CARE™, the first clinical-grade foundation model in healthcare with FDA cleared solutions, and deployed through Aidoc's aiOS™ platform, the solution is designed to help care teams attend to high–risk cases faster and more consistently across the health system.

This is the first-ever designation for AI with such broad coverage of medical conditions under one solution. 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. In this case, it enables parallel 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.

"With this designation and our ecosystem of specialized partners, we can deliver a broader set of solutions across many service lines. CARE's ability to detect, characterize, measure, and compare findings underpins both current and in-development applications from triage to report drafting," said Elad Walach, co-founder and CEO, Aidoc. "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."

Emergency departments and inpatient units are stuck in a vicious cycle. Rising patient volumes and a worsening shortage of physicians and nurses strain capacity, reducing efficiency and slowing care. Radiology is central: escalating imaging demand pushes radiology departments to their limits, creating delays that cascade downstream. Wait times are rising - in 2024, over one in four admitted patients waited four or more hours for a bed, with many waiting beyond 24 hours - and quality suffers as care continues under pressure. Comprehensive AI-powered triage can help break this cycle by flagging urgent cases and streamlining workflows to restore flow across the ED.

Aidoc has already become an essential tool for improving efficiency and care quality across health systems worldwide. With the most FDA-cleared AI indications in its category, Aidoc has scaled its impact across numerous disease states, all designed to accelerate patient care and ensure consistent quality at scale. Historically, these advancements expanded one condition at a time. CARE shifts this by enabling broad, simultaneous coverage across many pathologies. Clearance for multi-use systems covering tens of pathologies is complex and unprecedented, prompting renewed attention to design, development, and validation frameworks.

"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," said Michael Braginsky, co-founder and CTO, Aidoc. "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."

How It Works

CARE™ (Clinical AI Reasoning Engine) 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.

What's Next

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. Aidoc's momentum includes 18 FDA clearances, deployments across over 150 U.S. health systems and more than 1,600 hospitals worldwide, as well as collaborations with Nvidia and AWS, with over $150 million committed to CARE's development and deployment.

About Aidoc

Aidoc assists physicians in clinical decisions for over 45 million patients a year, helping health systems deliver smarter and faster care when it matters most. Its mission is to transform patient outcomes through "always on" clinical AI, eliminating preventable care gaps that lead to loss of lives and disabilities. Built on the proprietary aiOS™ platform, Aidoc seamlessly integrates real-time intelligence into provider workflows at the point of care. With the most FDA-cleared AI solutions in its category and deployments across 1,600 hospitals globally, Aidoc elevates physician and patient experience. Learn more at aidoc.com.

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SOURCE Aidoc