FDA clears novel AI chest x-ray technology for pneumothorax

The FDA has granted 501(k) clearance to Zebra Medical Vision’s HealthPNX technology—the world’s first x-ray-based AI alert system for triaging pneumothorax (PNX) patients, according to the Israel-based company.

Pneumothorax is commonly diagnosed via chest x-ray, but remains difficult to identify and is notorious for high disagreement rates among even the most experienced radiologists.  

HealthPNX, which is patent-pending, automatically detects findings associated with pneumothorax based on digital radiography scans and alerts medical teams with a “stat” warning. According to Zebra-Med, their technology can save physicians more than 80% of the time it takes to reach the acute condition compared to the commonly used first in first out (FIFO) method.

“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 Terence Matalon, MD, FACR, and chairman of imaging at Albert Einstein Medical Center in Philadelphia, in a news release.

“We are happy to add this important capability to our All-in-One (AI1) package and add more value to busy radiology departments,” said Eyal Gura, Zebra-Med’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 triage solution and improve their patient’s care and outcomes.”

Zebra-Med received FDA approval in July 2018 for its coronary calcium scoring algorithm which can accurately detect coronary artery disease.