Taiwan gives go-ahead to Lunit's breast cancer-detection AI software

Lunit said it received a class 2 medical device license for Lunit INSIGHT MMG, the company's artificial intelligence (AI) solution for mammography analysis, from the Taiwan Food and Drug Administration (TFDA).

According to Lunit, Lunit INSIGHT MMG is one of the company's most mature radiology products, analyzing mammography images with high speed and 96 percent accuracy. In addition, by detecting suspicious lesions in mammography images, the AI solution helps radiologists distinguish suspected tumor areas by providing the location of the lesion with an abnormality score reflecting the AI's confidence level.

Taiwan’s nod comes after the company received approval for the AI platform from the U.S. Food and Drug Administration last year and Health Canada this past June.

"We decided to introduce Lunit Insight MMG to speed up mammography reading and reduce the possibility of misdiagnosis," said Dr. Yeh Wei Cheng, director of the Department of Radiology at Nantou Hospital, one of the local hospitals using Lunit Insight MMG.

Cheng added that Lunit's AI tool is particularly effective in helping diagnose dense breasts, which are often more likely to be misdiagnosed among East Asian women, and has helped improve communication between radiologists and breast surgeons.

Lunit CEO Suh Beom-seok said, "Lunit INSIGHT MMG provides patients an opportunity to receive quick and accurate treatment while improving convenience for medical staff."

Suh added that the company expects the approval to serve as a bridgehead to expand business across the Greater China region.