Zebra Medical Gets FDA Clearance For AI-Powered Brain Bleed Alert

Israel’s Zebra Medical Vision, an AI medical imaging analytics company, announced Monday to have received FDA 510(K) clearance for an Intracranial Hemorrhage algorithm, titled HealthICH, that detects high-risk internal brain bleeds based on standard, non-contrast head CT scans.

Founded in 2014 by Eyal Toledano, Eyal Gura, and Elad Benjamin, Zebra uses AI to read medical scans and automatically detect anomalies. 

This is Zebra-Med’s third FDA 510(K) clearance, the first being for a coronary calcium scoring algorithm, which can detect coronary artery disease (CAD), and the second an AI-powered alert system based on chest X-rays called HealthPNX. Both HealthPNX and HealthICH are part of Zebra’s Multi-Modality AI Triage Solution which is “focused on helping institutions leverage the power of AI in acute situations where algorithms can help flag and prioritize cases,” the company says. These Zebra-Med products are part of the AI1 “all-in-one” bundle, providing hospitals with multiple medical AI programs at a fixed annual price.

HealthICH is comprised of a tailor-made neural network algorithm programmed to detect intracranial hemorrhages and prioritize acute cases, thus saving physicians over 80 percent of the time normally taken to reach the same conclusion, the company said in a statement.

Intracranial hemorrhages, more commonly known as brain-bleeds, have a 30-day mortality rate ranging from 35 percent to 52 percent. Half of this mortality occurs within the first 24 hours – necessitating precise and rapid detection. In increasingly busy ER rooms, with understaffed and overworked medical teams, automated AI analytic systems present the most promising method of early detection thus becoming integral to auspicious patient outcomes.     

“We are thrilled to get a 3rd 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,”said Gura, Zebra Med’s CEO.