Zebra Medical Vision, the AI medical imaging insights company, announced Wednesday it has received its fourth FDA 510(k) clearance for the HealthCXR device intended for the identification and triaging of pleural effusion in chest X-rays.
This is the first-ever FDA nod for pleural effusion, an abnormal accumulation of fluid within the pleura, also called “water in the lungs.” The condition can be caused by a variety of medical issues, including acute conditions such as severe pneumonia, trauma, and pulmonary edema.
Zebra Medical Vision’s newest solution aims to facilitate a faster diagnosis for the patients more likely to have acute pathology.
The company’s solution automatically identifies acute findings that suggest PE based on CR, DR, and/or DX scans and notifies radiologists and clinicians, which enables them to address the cases more efficiently and provide optimized treatment.
Founded in 2014 by Eyal Toledano, Eyal Gura, and Elad Benjamin, Zebra uses AI to read medical scans and automatically detect anomalies. Through its development and use of different algorithms, Zebra Medical has been able to identify visual symptoms for diseases such as breast cancer, osteoporosis, and fatty liver as well as conditions such as aneurysms and brain bleeds.
This new clearance joins the company’s FDA clearance for a chest x-ray product from earlier in the year, which focused on pneumothorax. It was also the first of its kind, Yaron Blinder, senior product manager at Zebra Medical Vision said in a blog post.
“We are happy with the fourth FDA nod for an additional medical solution that will leverage AI in healthcare, and improve patient care,” said Gura in a statement. “Adding a greater number of capabilities to our chest X-ray package is key for increasing doctors’ trust, and the use of AI.”
“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. 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,” said Dr. J.J. Visser, radiologist and head of imaging IT and value-based imaging at Erasmus MC University Medical Center.