Zebra Medical Vision said today that it won FDA 510(k) clearance for its HealthPNX artificial intelligence-powered pneumothorax alerting system designed to analyze chest X-rays.
The Israel-based developer said that the newly cleared technology is designed to automatically detect findings suggestive of pneumothorax based on chest x-rays or digital radiography scans, and to alert physicians of the condition.
“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,” Dr. Terence Matalon of the Albert Einstein Medical Center said in a press release.
Zebra Medical Vision touted the FDA clearance as the first of it’s kind, estimating that the system could save physicians more than 80% of the time required to reach an acute condition compared to a traditional first in first out methodology.
The company said that its chest X-ray AI network was trained using millions of images to identify more than 40 common clinical findings.
“We are happy to add this important capability to our All-in-One package and add more value to busy radiology departments. 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 patients’ care and outcomes,” co-founder & CEO Eyal Gura said in a prepared statement.
The clearance follows a previously received FDA approval won last July for a Coronary Calcium Scoring algorithm.