Aidoc receives Breakthrough Device Designation from FDA for multi-triage imaging AI
“The new technology means our mission is at hand - to support physicians in every patient encounter,” said Elad Walach, Co-Founder and CEO.
Israeli medtech startup Aidoc has announced it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for a new multi-triage solution that spans numerous acute findings in CT scans. The designation applies to a workflow powered by Aidoc’s CARE foundation model, which enables simultaneous coverage of multiple pathologies and built specifically for clinical AI.
“This Breakthrough Designation is a powerful validation of our CARE foundation model and its ability to change the way technology enables quality care,” said Elad Walach, co-Founder and CEO. “The new technology means our mission is at hand - to support physicians in every patient encounter. However, this requires a shift not just in technology, but also in regulation. We’re very excited by FDA’s leap in its recognition of the importance and value of multi-indication AI models, as reflected by this breakthrough designation, acknowledging our technology has the potential to help patients with a wide array of life-threatening and debilitating diseases.”
AI has been increasingly adopted in imaging to address staffing shortages and delays in emergency departments. Median visit times in U.S. emergency departments now exceed 160 minutes, the longest in more than a decade, with many patients waiting more than four hours for a bed. Delayed imaging interpretation is a contributing factor and Aidoc says its multi-triage approach can help prioritize high-risk cases and accelerate diagnosis.
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Aidoc previously expanded its FDA-cleared offerings one condition at a time. According to the company, CARE enables “broad, simultaneous coverage across many pathologies,” with the new designation allowing parallel FDA review of multiple indications under a single submission.
“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,” added Michael Braginsky, co-founder and CTO. “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.”
The company says additional CARE-powered solutions, including auto-generation of draft reports, are in development. It has 18 FDA clearances to date and reports its tools assist in the clinical decisions of more than 45 million patients annually across 150 U.S. health systems and 1,600 hospitals worldwide. In July 2025, the company raised $150 million at a valuation higher than its previous round, bringing its total funding to $370 million.
