AI triage solution for brain bleeds gains FDA clearance

Zebra Medical Vision announced Monday, June 17, that its AI solution for intracranial hemorrhage (ICH) alerts has gained FDA approval.

HealthICH identifies suspected ICHs, or brain bleeds, on head CT scans and automatically alerts the necessary providers. This is the company’s third FDA approval overall, and its HealthPNX solution for detecting signs of pneuomothorax received approval back in May.

“We are thrilled to get a third nod from the FDA in such a short time and to be able to add such an important new finding to our growing AI1‘all-in-one’ package,” Eyal Gura, Zebra Medical Vision CEO, said in a prepared statement.

“We have deployed Zebra Medical Vision's triage head CT solution that alerts our department of acute cases of intracranial hemorrhage,” Stanley Lu, MD, a radiologist at Monmouth Medical Center in Long Branch, New Jersey, said in the same statement. “We have found the technology to be helpful as a second layer of analysis augmenting the clinical team's detection and response time for acute cases.”