Shefayim-based healthcare imaging analytics start-up Zebra Medical Vision has received US Food and Drug Administration (FDA) approval for HealthPNX, an artificial intelligence-powered alert for pneumothorax detected in chest X-rays.
Pneumothorax, also known as a collapsed lung, is a condition in which there is an accumulation of gas within the pleural space between the lung and chest wall.
The condition is most commonly diagnosed by chest X-ray but is one of the hardest conditions to interpret. Some 74,000 Americans are estimated to be impacted annually by misdiagnosis or late diagnosis of pneumothorax.
The FDA 510(k) clearance focuses on an artificial intelligence-powered alert for urgent findings of pneumothorax and demonstrates potential, Zebra said, to significantly reduce turnaround time and increase radiologist confidence in making the diagnosis.
The patent-pending technology automatically detects findings suggestive of pneumothorax in CXR or digital radiography scans and alerts relevant hospital medical teams.
The deep-learning solution, trained by using millions of images to identify over 40 common clinical findings, can reduce the time taken to diagnose the acute condition by more than 80%, the company said.
“We are happy to add this important capability to our All-in-One (AI1) package and add more value to busy radiology departments,” said Zebra CEO and co-founder Eyal Gura.
“Health providers across the US, that already use the many Zebra-integrated PACS and work-list systems, will be able to easily deploy our solution and quickly realize return on investment and improved outcomes.”
The FDA approval announced on Monday is the company’s second to date, after receiving the green light for its coronary artery disease detection algorithm last July.
Zebra has also received CE approval for nine algorithms, enabling the company to commercialize its products in the European Economic Area.
“In a clinical validation study we performed, Zebra-med’s acute CXR pneumothorax and CT brain bleed products demonstrated a promising potential to substantially reduce turnaround time and increase the radiologist’s confidence in making these diagnoses,” said Albert Einstein Medical Center chairman of imaging Dr. Terence Matalon.
“Zebra-med’s AI1 Triage Solution is the first of its kind for both CTs and X-rays, and currently addresses two acute conditions: intracranial hemorrhages (head CTs, FDA pending), and pneumothorax (chest X-rays).”
Founded in 2014, Zebra has raised $50 million in funding to date, including backing from leading healthcare funds and investorsa aMoon, OurCrowd Qure and Nvidia.