Lunit Obtains Sales Approval for 'Lunit Insight' in Canada

[Asia Economy Reporter Chunhee Lee] Medical artificial intelligence (AI) company Lunit announced on the 20th that its AI image analysis solution 'Lunit INSIGHT' obtained 'Medical Device Sales Approval (Class II Medical Device)' from Health Canada on the 14th (local time).

This sales approval was granted for two products: the chest X-ray image analysis solution 'Lunit INSIGHT CXR' and the mammography image analysis solution 'Lunit INSIGHT MMG.' Lunit INSIGHT CXR diagnoses 10 types of chest diseases such as lung nodules, pulmonary fibrosis, and pneumothorax based on AI. It detects suspected disease areas and their likelihood within chest X-ray images with 97-99% accuracy, assisting medical professionals in fast and accurate interpretation. Lunit INSIGHT MMG detects the presence of breast cancer in mammography images based on AI. It identifies suspected breast cancer areas with 96% accuracy and provides location information and suspicion levels numerically to support medical diagnosis.

Following the approval of the Lunit INSIGHT product line by the U.S. Food and Drug Administration (FDA) in November last year, Lunit has now obtained approval in Canada, preparing to enter the North American market, the world's largest pharmaceutical and medical device market. The Canadian medical device market, ranked eighth globally, is rapidly growing alongside an aging population. According to Statistics Canada, the population aged 65 and over is expected to increase from about 17% of the total population in 2019 to about 23% by 2031. Accordingly, the Canadian medical device market size is projected to grow from $7.2 billion USD (approximately 9.3125 trillion KRW) in 2019 to $9.2 billion USD (approximately 11.8993 trillion KRW) by 2024, with an expected annual growth rate of 4.6%.

Seobeomseok, CEO of Lunit, said, "With this approval in Canada, we will actively advance into the North American market, including the United States," and added, "Since Lunit INSIGHT is already recognized for its value in the global market, we will strive to successfully enter the North American market, the world's largest healthcare market."

This content was produced with the assistance of AI translation services.