www.fdanews.com/articles/205383-lunit-gets-510k-clearance-for-chest-x-ray-triage-software
Lunit Gets 510(k) Clearance for Chest X-ray Triage Software
November 17, 2021
South Korea-based Lunit has received the FDA’s 510(k) clearance for its artificial intelligence (AI)-based chest x-ray triaging software, Lunit Insight CXR Triage.
The triage system prioritizes urgent cases, such as pleural effusion and pneumothorax, notifying physicians immediately after the exam to enable them to make a faster diagnosis.
The software, which was “trained” using more than 160,000 chest radiographs with computed tomography images, offers 94-96 percent sensitivity and 95-99 percent specificity on pleural effusion and pneumothorax, the company said.