Israel’s Zebra Medical Vision has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its artificial intelligence (AI)-powered HealthCXR device, which enables identification and triaging of pleural effusion in chest X-rays.
In May, the company also received FDA clearance for its AI-powered chest X-ray triage product, HealthPNX.
The latest product adds to Zebra’s expanding AI1 lot of triage and prioritisation applications for chest X-rays.
Based on CR, DR and DX scans, Zebra-Med’s HealthCXR device can automatically identify pleural effusion, a condition of abnormal accumulation of fluid within the pleura. Following the identification, radiologists are alerted so that they can provide faster treatment and accordingly prioritise cases.
Pleural effusion is caused by several medical issues, which include severe pneumonia, trauma and pulmonary oedema.
As the newest solution facilitates a quick diagnosis for patients who stand at high risk of acute pathology, efficient treatment and optimised patient care becomes possible, claimed Zebra Medical Vision.
Erasmus MC University Medical Center radiologist and head of imaging IT and value-based imaging JJ Visser said: “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.”
Zebra Medical Vision co-founder and CEO Eyal Gura said: “We are happy with the 4th FDA nod for an additional medical solution that will leverage AI in healthcare, and improve patient care. Adding a greater number of capabilities to our Chest X-ray package is key for increasing doctors’ trust, and the use of AI.”
Zebra-Med joined the FDA’s digital health software pre-certification pilot programme, which will help in the development of a regulatory framework to have a more streamlined regulatory oversight of software-based healthcare devices.