Lunit wins FDA approval for its AI-based Chest X-ray Triage solution

  • The company plans to fast-track business in the U.S. market using its partnerships with GE Healthcare, Philips and Fujifilm
  • It marks as Lunit’s 1st FDA 510(k) approval from its AI software product portfolio for radiology that focuses on triaging developing cases found in chest X-ray

Lunit, a leading medical AI software provider, has recently attained clearance from the US FDA (Food and Drug Administration) for its Artificial Intelligence (AI)-based image analysis solution, Lunit Insight CXR Triage.

For information, Lunit Insight CXR Triage uses AI technology to classify normal and abnormal findings of emergency conditions, such as pleural effusion and pneumothorax. It also interprets pictures for nine lung diseases, including pulmonary nodules and pulmonary sclerosis.

The solution quickly categorizes image information that needs emergency treatment, thereby offering pronounce use in environments such as ICU (intensive care unit) or emergency room of medical institutions.

As per company reports, the Lunit Insights CXR triage demonstrated 94% to 96% sensitivity with 95% to 99% specificity in organizing 160,000 chest X-ray images of patients with emergency diseases like pneumothorax and pleural effusion.

Lunit plans to ramp up expanding the sales of Lunit Insight CXR Triage based on the FDA's clearance in the global market.

According to Lunit, it will be focusing on delivering CXR Triage solution to mobile-based X-ray medical devices that are primarily used in emergency care environments through collaborations with global biotechnology companies such as Philips, GE Healthcare, and Fujifilm.

Lunit CEO, Seo Bum-Seok said that the FDA clearance for Lunit Insight CXR Triage brings fourth their company’s new entry in the U.S. — the world's largest pharmaceutical and medical device market. The firm will do its best to get FDA approval for more unique products beginning from the recent clearance.

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By Shreya Bhute

With corporate exposure in software and marketing, Shreya was always intrigued by content development. Having pursued her graduation in I.T. engineering, she works as a content writer for and jots down news articles across distinct domains including technology, business and healthcare.