AI-powered radiology worklist receives CE mark

Zebra Medical Vision (Zebra-Med), an Israel-based deep learning imaging analytics company, announced it was granted CE certification for two of its AI-based products intended to speed up clinical review and diagnosis. One is for pneumothorax in chest x-rays and the other helps radiologists detect brain bleeds in CT scans.

A CE Mark designates a product’s conformity with the European Union’s health and safety standards.

Zebra-Med’s AI-based technology reduces the time it takes radiologists to identify the conditions by 80 percent, allowing for better quality and timeliness of treatment. 

“In a clinical validation study we performed, Zebra-Med’s acute CXR pneumothorax and CT brain bleed products demonstrated a promising potential to substantially reduce turnaround time and increase the radiologist's confidence in making these diagnoses,” said Terence Matalon, MD, Albert Einstein Medical Center, Philadelphia, in a prepared statement. "Seeing the software in action emphasized key aspects AI solutions must address in order impact our field: high accuracy, speed, seamless integration to our workflow, and the ability to work on multi modalities—both x-ray and CT."

Zebra-Med’s technology can connect to most radiology departments’ picture archiving and communication system (PACS) to analyze scans. Once an anomaly is detected, the system alerts the worklists of various departments in the hospital (including emergency and radiology).

At present, the AI-based solution is available for purchase in the EU; however, it is still pending FDA clearance for use in the United States.