• Lunit’s AI solutions for radiology received medical device licenses from Health Canada

• Following last year’s FDA clearance, Lunit’s Canadian commercial approval to accelerate expansion in the North American market

  
  

Lunit today announced that it received commercial approval in Canada for Lunit INSIGHT, the company’s AI solution suite for radiology. On June 14, Canadian medical device regulator Health Canada issued class 2 medical licenses for Lunit’s AI solution for chest x-ray, ‘Lunit INSIGHT CXR’ and ‘Lunit INSIGHT MMG,’ AI solution for mammography.

Lunit INSIGHT CXR detects suspicious lesions in chest x-ray images, helping radiologists distinguish suspected disease areas by providing the location of the lesion with an abnormality score that reflects the AI’s confidence level. Trained with over 3,500,000 clinically proven data sets, Lunit INSIGHT CXR can detect 10 of the most common chest abnormalities, including supporting tuberculosis screening, with 97-99% accuracy.

Along with Lunit’s AI solution for chest x-rays, Lunit INSIGHT MMG is one of the company’s most mature radiology products, analyzing mammography images with high speed and 96% accuracy. The product is trained with more than 240,000 data sets, including over 50,000 biopsy-proven breast cancer cases, and has shown to reduce the chances of undetected breast cancer cases by 50% in mammogram screenings.

Following last year’s FDA approval in the U.S., Lunit’s commercial approval in Canada signals the company’s continued expansion in the North American market.

As the eighth largest in the world, the Canadian medical device market is growing rapidly along with the country’s aging population. According to Statistics Canada, the number of persons aged 65 or older is expected to increase from approximately 17% of the total population in 2019 to approximately 23% in 2031^[1].

Accordingly, the medical device market in Canada is expected to grow from about $7.2 billion in 2019 to $9.2 billion in 2024, with an annual average growth rate expected to be 4.6%^[2].

“This is an important milestone for Lunit, especially after our FDA clearance. North America constitutes the biggest proportion of the global medical device market, and we will make a full-fledged entry following our Canadian and U.S. commercial approval,” said Brandon Suh, CEO of Lunit. “As our AI technology continues to gain global recognition, we will do our best to become a global leader in the medical devices field.”

^[1] “Population Projections for Canada,” Statistics Canada (2019.09)

^[2] “Canada Medical Devices Report,” Fitch Solutions (2020.2Q)