Imaging artificial intelligence firm Harrison.ai scores FDA breakthrough device designations
Harrison.ai has scored three breakthrough device designations from the U.S. Food and Drug Administration, the imaging artificial intelligence firm announced recently.
This includes the Australia-based company’s Comprehensive Care triage and prioritization solution for obstructive hydrocephalus—a condition where cerebrospinal fluid cannot flow properly through the brain’s ventricles. Harrison.ai said the product is among only 13% of FDA breakthrough devices that have received 510(k) marketing authorization.
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. The solution also is 1 of only 2 radiology FDA breakthrough devices that have gone on to become eligible for Medicare’s New Technology Add-on Payment (NTAP), aimed at accelerating seniors’ access to emerging treatments.
“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,” Dimitry Tran, MBA, co-founder of Harrison.ai, said in an Oct. 9 announcement. “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.”
The AI vendor also touted the ongoing development of its auto-created draft reporting model, powered by deep learning. Its technologies now support over 1,000 customer sites across the U.S., Europe, Asia and Australia. Earlier this year, Harrison.ai earned $112 million in new funding while also opening offices in Boston.
Meanwhile, the company also announced on Oct. 7 that it is retiring the Annalise.ai branding of its solutions, instead using the Harrison.ai name. The transition will not impact existing solutions, agreements or support, it emphasized. In the coming months, the Harrison.ai name and identity will be applied “consistently across all products and communications,” it said.
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.