Harrison.ai Reaches 3 FDA Breakthrough Nods for CT Imaging AI

Harrison.ai, a company specializing in clinical artificial intelligence (AI), now possesses three U.S. Food and Drug Administration (FDA) breakthrough device designations for CT imaging solutions.

These advances feature comprehensive AI models trained on one of the world’s largest annotated radiology datasets, according to the company. Over a million clinical studies and 550 million expert-labelled findings were developed and validated with input from over 140 board-certified radiologists.

One of these deep learning models with its foundation model is also powering the company’s auto-created draft reporting, which is already in development.

The Harrison.ai Comprehensive Care – Obstructive Hydrocephalus triage and prioritization solution is among 13% of FDA breakthrough devices that have ever received marketing authorization. It’s also one of the two radiology FDA breakthrough devices to become eligible for Medicare NTAP (New Technology Add-on Payment), which speeds U.S. hospital access and reimbursement for new technology that offers substantial improvement over existing services.

The company’s clinical and workflow solutions currently support more than 1,000 sites in the U.S., Europe, Asia, and Australia.

“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.”