Zebra Medical wins FDA clearance for AI intracranial hemorrhage detection

Last month, Zebra Medical received FDA approval for HealthPNX, an artificial intelligence-powered alert for pneumothorax detected in chest X-rays.

By EYTAN HALON
An illustration of a radiologist analyzing a head CT scan (photo credit: ZEBRA MEDICAL VISION)
An illustration of a radiologist analyzing a head CT scan
(photo credit: ZEBRA MEDICAL VISION)
Israeli medical imaging analytics start-up Zebra Medical Vision has received US Food and Drug Administration (FDA) clearance for its artificial intelligence-powered product for detecting intracranial hemorrhages.
HealthICH, the third product developed by the company to receive FDA 510(k) clearance, automatically identifies suspected internal brain bleeds based on standard, non-contrast head CTs, significantly reducing triage turnaround time and increasing diagnosis confidence.
Last month, Zebra Medical received FDA clearnace for HealthPNX, an artificial intelligence-powered alert for pneumothorax detected in chest X-rays.
An intracranial hemorrhage can occur as a result of traumatic injuries, such as falls or crashes, ruptured arteries (aneurysms), stroke or cancer. Timely diagnosis of active bleeding is critical for successful care, with half of mortality occurring within the first 24 hours and 30-day mortality rates ranging from 35% to 52%.
Approximately 40,000 to 67,000 cases of spontaneous intracranial hemorrhage are identified annually in the United States, with strokes and associated healthcare expenses costing the US health system $34 billion per year.
The HealthICH algorithm, the company says, is comprised of a unique, tailor-made neural network architecture designed to identify an intracranial hemorrhage while tackling several challenges, such as relatively small bleed sizes and common artifacts seen within the brain, such as metal and motion artifacts.
“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,” said Zebra Medical CEO Eyal Gura.
In July 2018, Zebra Medical received FDA clearance for its coronary artery disease detection algorithm. The company has also received CE approval for nine algorithms, enabling the company to commercialize its products in the European Economic Area.
“We have deployed Zebra Medical Vision’s triage head CT solution that alerts our department of acute cases of intracranial hemorrhage,” said radiologist Dr. Stanley Lu, head of Neuroradiology at New Jersey’s Monmouth Medical Center.
“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.”
Co-founded in 2014 by Gura together with Eyal Toledano and Elad Benjamin, Zebra has raised $50 million in funding to date, receiving backing from leading healthcare funds and investors including aMoon, OurCrowd Qure and Nvidia.