Harrison.ai Redefines CT Imaging AI With Three FDA Breakthrough Designations

October 09, 2025 at 06:00 AM EDT

Harrison.ai, a global leader in clinical artificial intelligence, today announced it now holds three FDA Breakthrough Device Designations for CT imaging solutions, further solidifying its position at the forefront of next-generation AI for driving efficient, quality patient care.

At the heart of these advances are comprehensive AI models, trained on one of the world’s largest annotated radiology datasets: over one million clinical studies and 550 million expert-labelled findings, developed and validated with input from more than 140 board-certified radiologists. One of these deep learning models, in tandem with its foundation model, is also powering Harrison.ai’s auto-created draft reporting, already in development.

Further strengthening its U.S. momentum, Harrison.ai Comprehensive Care - Obstructive Hydrocephalus triage and prioritization solution is among only 13% of FDA Breakthrough devices that have ever received marketing authorization (e.g., 510(k) clearance). It is also one of only two radiology FDA Breakthrough devices that have ever gone on to become eligible for Medicare NTAP (New Technology Add-on Payment), which accelerates U.S. hospital access and reimbursement for new technology that provides substantial clinical improvement over existing services, consistent with an FDA Breakthrough Device Designation.

Today, Harrison.ai’s clinical and workflow solutions support over 1,000 customer sites across USA, Europe, Asia, and Australia—underscoring the company’s global track record for clinical trust and real-world impact.

“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.”

About Harrison.ai

Harrison.ai is a global healthcare technology company enhancing clinician capacity and patient care through AI automation. Clinician-led and patient-first, our suite of solutions supports earlier, more accurate diagnoses and seamlessly integrate into clinical workflows. Harrison.ai solutions are available in 40+ countries and to half of all Australian radiologists. They are clinically deployed at 1,000+ customer sites globally, including 40+ NHS Trusts and all public emergency departments in Hong Kong. With 3,400+ clinicians using our tools, Harrison.ai has impacted 6.7 million patients' lives to date.

Visit: Harrison.ai.