FDA Grants 510(k) Clearance for Chest X-Ray Triage Product

The US Food and Drug Administration recently granted 510(k) clearance for HealthPNX, an AI-based chest x-ray triage system alert for pneumothorax (PNX).

The product, which is being produced by Zebra Medical Vision, is an AI alert for urgent findings of pneumothorax and it demonstrates potential to lower turnaround time and increase a radiologist’s confidence in making their diagnoses.

"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 Dr. Terence Matalon, Chairman of Imaging at Albert Einstein Medical Center.

The technology, which is still patent pending, automatically detects findings suggestive of pneumothorax based on chest x-rays or digital radiography. For physicians who use Zebra Medical Vision’s “All in One” (Al1) solution, the scan is flagged so the radiologist can address it.

Authors noted that this is a first of its kind FDA cleared solution and could potentially save physicians more than 80% of the time taken to reach to acute condition. This is at least the second FDA approval Zebra Medical has received in a year. In July 2018, they received an approval for a product that focuses on coronary calcium scoring algorithm, which can detect coronary artery disease.

More information about Zebra Medical’s HealthPNX is available on their website.