FDA grants Breakthrough Device status to artificial intelligence triage solution from Aidoc
The U.S. Food and Drug Administration has granted Breakthrough Device status to an artificial intelligence solution from Aidoc.
The New York-based radiology vendor announced the news Tuesday, with it applying to a novel product that flags a wide array of life-threatening, time-sensitive conditions in CT scans, “all within a single workflow.” Aidoc said it believes this is the first-ever such FDA designation for a device covering a wide range of conditions in one solution.
According to the FDA, the Breakthrough Device Program is aimed at granting physicians timely access to new medical devices by speeding up development, assessment and review for premarket approval.
“What excites me most isn’t the technology itself; it’s what this means for patients and providers,” Aidoc CEO Elad Walach said in a social media post Tuesday. “Breaking bottlenecks that delay care, supporting overburdened clinical teams, and moving toward a future where no critical finding is missed.”
Aidoc said the new solution is built using CARE—its clinical-grade foundation model, in which products are trained on vast amounts of data, making them easily adaptable to a wide range of tasks. Breakthrough Device designation will enable parallel review of “double-digit indications” within a single FDA submission, the vendor said. This marks “an important step toward bringing comprehensive, high–accuracy clinical AI to routine care while maintaining robust safety and effectiveness standards.”
Walach and colleagues said this “milestone” will help advance the company’s push toward creating a “comprehensive, integrated clinical AI package.” The vendor now boasts 18 FDA clearances, deployments across more than 150 U.S. health systems, and over $150 million committed by AWS and Nvidia toward CARE’s development.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.