The Food and Drug Administration has cleared for clinical use an artificial intelligence tool that scans chest X-rays for a dangerous lung condition.
The FDA 510(k) clearance is for HealthPNX, an AI alert developed by Zebra Medical Vision for pneumothorax.
The FDA action clears the use of the tool for urgent findings of the condition, offering the potential to reduce turnaround times and increase radiologists’ confidence in making the diagnosis.
Pneumothorax results when there is an accumulation of gas within the pleural space between the lung and chest wall. Without prompt management, pneumothorax can result in total lung collapse or other potentially fatal complications.
While it’s most commonly diagnosed through chest X-ray scans, it is one of the most difficult for radiologists to interpret, with high disagreement rates even among experienced radiologists. Misdiagnosis or late diagnosis of pneumothorax affects about 74,000 Americans every year, Zebra Medical estimates.
The new technology automatically detects findings that indicate pneumothorax based on CXR or digital radiography scans, and then alerts the medical team on the findings. In facilities where some Zebra Medical solutions are integrated into radiologists’ worklists, the scan is flagged so a radiologist can address it quickly.
Zebra Medical’s research lab trained its chest X-ray AI network by using millions of images to identify more than 40 common clinical findings. The results of the work resulted in high rates of agreement between the algorithm and human radiologist experts.
“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,” says Terence Matalon, MD, chairman of imaging at Albert Einstein
Medical Center. 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).
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