Zebra Medical Vision, a medical imaging analytics company, has received FDA 510(k) clearance for “HealthPNX – an AI alert for pneumothorax (PNX), based on chest X-rays.” Zebra is an OurCrowd portfolio company.
Pneumothorax is described as a condition in which there is an accumulation of gas within the pleural space between the lung and the chest wall.
Pneumothorax may lead to total lung collapse and other potentially fatal complications. A standard scan or X-ray is said to be hard to interpret and approximately 74,000 US individuals are misdiagnosed or late diagnosed each year.
The patent pending technology automatically detects findings suggestive of Pneumothorax based on CXR or digital radiography (DR) scans, and alerts the medical team.
Zebra says this first of its kind FDA cleared solution can save physicians more than 80% of the time taken to reach the acute condition.
“We are happy to add this important capability to our All-in-One (AI1) package and add more value to busy radiology departments,” commented Eyal Gura, Zebra’s CEO and co-founder. “Health providers across the U.S. that already use the many zebra-integrated PACS and worklist systems, will be able to easily deploy our solution and quickly realize ROI and improved outcomes”
Zebra has previously received FDA approval in July of 2018. At that time, approval was received for a process that can detect coronary artery disease.
Zebra reports that it has nine CE marked products and more FDA pending applications in the pipeline.
Zebra Medical Vision has raised $50 million in early-stage funding to date.
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