Zebra Medical Vision, a medical imaging analytics start-up based in Shefayim north of Tel Aviv, has received US Food and Drug Administration (FDA) clearance for its artificial intelligence-powered solution to identify pleural effusion, also known as “water on the lungs.”
The company, the recipient of three previous FDA clearances for AI-powered medical imaging technologies, has received clearance for its HealthCXR device for the identification and triage of pleural effusion in chest x-rays.
The deep-learning solution automatically identifies findings suggestive of pleural effusion based on CR, DR and DX scans, quickly notifying radiologists and enabling them to both effectively address and prioritize urgent cases.
In the United States, approximately 1.5 million people are diagnosed annually with pleural effusion, a build-up of fluid between the layers of tissue lining the lungs and chest cavity. Most commonly caused by congestive heart failure, pleural infection and malignancy, almost one-third of pleural effusion patients die within one year of hospital admission.
By providing radiologists with additional insights of pleural effusion, Zebra says its newest solution can facilitate “quicker diagnosis for the patients more likely to have acute pathology,” and lead to more efficient treatment and optimized patient care.
“We are happy with the fourth FDA nod for an additional medical solution that will leverage AI in healthcare, and improve patient care,” said Zebra CEO and co-founder Eyal Gura. “Adding a greater number of capabilities to our chest x-ray package is key for increasing doctors’ trust, and the use of AI.”
The latest product will be added to Zebra’s growing AI1 bundle of applications for chest x-rays, which will be showcased at next month’s annual meeting of the Radiological Society of North America.
The company has already received FDA clearance for AI-powered technologies identifying pneumothorax, intracranial hemorrhage and coronary artery disease.
“Based on the real-world application of this product, we saw that Zebra-Med’s automatic identification of pleural effusion on chest x-rays can play a significant role in triage,” said Dr. Jan-Jaap Visser, radiologist and head of Imaging IT and Value-Based Imaging at Rotterdam’s Erasmus MC University Medical Center.
“It could be a relevant indicator for acute cardiopulmonary disease, so that clinical management can be adopted, as soon as possible, in order to provide optimal patient care.”
Zebra also announced that it will join the FDA’s digital health software pre-certification pilot program which aims to develop a regulatory framework providing a more streamlined and efficient regulatory oversight of software-based medical devices.