BOSTON, Mass. — Harrison.ai, a global leader in clinical artificial intelligence, announced it has received three FDA Breakthrough Device Designations for its CT imaging solutions, reinforcing its leadership in developing next-generation AI technologies that enhance efficiency and quality in patient care.
The company’s AI advancements are powered by one of the world’s largest annotated radiology datasets, encompassing more than one million clinical studies and 550 million expert-labelled findings. Developed and validated with input from over 140 board-certified radiologists, these comprehensive deep learning models form the backbone of Harrison.ai’s imaging innovations. One of the company’s deep learning models, combined with its foundation model, also powers an auto-generated draft reporting system currently in development.
Among the newly recognized technologies, Harrison.ai’s Comprehensive Care – Obstructive Hydrocephalus triage and prioritization solution has achieved a rare distinction. It is among only 13 percent of FDA Breakthrough devices to receive marketing authorization, such as 510(k) clearance, and one of just two radiology devices to become eligible for Medicare’s New Technology Add-on Payment (NTAP). The NTAP designation accelerates hospital access and reimbursement for technologies that demonstrate substantial clinical improvement over existing methods, aligning with the FDA’s Breakthrough Device program standards.
Today, Harrison.ai’s AI-powered clinical and workflow solutions are deployed at more than 1,000 customer sites across the United States, Europe, Asia, and Australia, underscoring its growing global presence and trust among healthcare institutions.
“We’re proud to partner with leading U.S. health systems and private practices who share our commitment to bringing advanced AI technology to patient care,” said Dimitry Tran, co-founder of Harrison.ai. “Those partners have expressed appreciation that Harrison.ai’s Comprehensive Care – Obstructive Hydrocephalus triage and prioritization solution is eligible for NTAP, recognizing it as another step forward in bringing clinically proven AI solutions into real-world practice.”
