FDA approves first AI chest X-ray

The FDA has given 510(k) clearance to an AI alert for urgent finding of a collapsed lung in chest X-rays. The approval is a first for an AI-based chest X-ray solution that can help doctors make quicker diagnoses from one of the world’s most used imaging modalities.

Zebra Medical Vision, a deep learning imaging analytics company based in Israel, received FDA clearance for HealthPNX, which uses AI to alert findings of pneumothorax, a condition that can lead to total lung collapse and potentially fatal complications. The condition is hard to diagnosis, and late diagnosis or misdiagnosis of it affects roughly 74,000 Americans annually, according to the company.

The AI network was trained on millions of images to determine more than 40 clinical findings, and, compared to the traditional First In First Out (FIFO) methodology, the use of the HealthPNX, with Zebra-Med’s All in one (AI1) solution integrated into the radiologist’s worklist, can save physicians more than 80% of the diagnosis time.

“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,” Terence Matalon, MD, chairman of imaging at Albert Einstein Medical Center, said in a statement.

Zebra-Med also recently received FDA approval for its coronary calcium scoring algorithm that detects coronary artery disease.