Korean AI startup Lunit has received clear regulations from Health Canada for AI solutions for radiology.
According to a press release, both the INSIGHT CXR chest x-ray solution and the INSIGHT MMG mammography software have now been approved for commercial release in Canada.
INSIGHT CXR can detect 10 most common breast abnormalities with 97%-99% accuracy while INSIGHT MMG analyzes mammogram images with 96% accuracy.
WHY IT IMPORTANT
The Canadian medical device market is one of the largest in the world. Its value is expected to grow to $9.2 billion by 2024 from $7.2 billion in 2019. Canada also has an aging population with people aged 65 and over making up 23% of the total population. in 2031.
TREND TO BIGGER
This latest regulatory notice is subject to approvals issued by US Food and Drug Administration with the same Lunit AI solutions last year. Chief Executive Officer Brandon Suh said it will “officially enter” the North American market following these approvals.
In other news, Lunit just filed last week a registration statement with the Korea Exchange for its initial public offering in July. The company plans to issue a total of 1.12 million shares worth between $34 and $38 each. Before the IPO, Lunit launched in November a fundraiser where it raised funds 61 million dollars.