Lunit receives FDA clearance for AI software that triages urgent chest X-rays


Lunit’s AI-based software used for triaging chest X-rays has received Food and Drug Administration 510(k) clearance, the company announced Monday.

The software is designed to analyze chest X-rays for specific abnormalities that would be considered urgent findings.    

Trained on over 160,000 chest images, including radiographs and CT scans, the software is said to have 94%-96% sensitivity and 95%-99% specificity for detecting pleural effusion and pneumothorax. Lunit’s website also claims the system detects 10 of the most common image anomalies with 97%-99% accuracy and…



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