Zebra Medical nets FDA clearance for AI to spot pneumothorax

Zebra Medical Vision has received a go-ahead from the FDA to use artificial intelligence to quickly scour X-rays and alert clinicians for signs of pneumothorax, the potentially fatal buildup of air between the lung and the chest wall.

The platform’s goal is to reduce the turnaround time in urgent cases and increase radiologists' confidence in their diagnoses. Without an emergency intervention, the internal pressure can cause the entire lung to collapse.

Though commonly diagnosed by a chest X-ray, pneumothorax remains one of the more difficult conditions to interpret. Zebra Medical, a former Fierce 15 winner, said that missed or late diagnoses can impact about 74,000 patients per year in the U.S., and it is known for high disagreement rates among experienced radiologists.

Zebra Medical said its solution can help physicians reach a diagnosis more than 80% faster compared to first-in-first-out methods in emergency radiology. Its chest X-ray AI network was trained using millions of images to identify more than 40 common clinical findings, the company said.

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“We are happy to add this important capability to our All-in-One package and add more value to busy radiology departments,” CEO and founder Eyal Gura said in a statement. “Health providers across the U.S. that already use the many Zebra-integrated PACS and worklist systems will be able to easily deploy our triage solution and improve their patient’s care and outcomes.”

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The Israel-based company’s other AI-based solution, which examines head CT scans for signs of intracranial hemorrhage, is still pending approval by the FDA. It previously received an agency green light last July for its algorithm to detect coronary artery disease.