South Korean AI startup Lunit has received regulatory clearances from Health Canada for its AI solutions for radiology.
According to a press statement, both its chest x-ray solution INSIGHT CXR and mammography software INSIGHT MMG are now approved for commercial release in Canada.
INSIGHT CXR can detect 10 of the most common chest abnormalities with 97%-99% accuracy while INSIGHT MMG analyses mammography images with 96% accuracy.
WHY IT MATTERS
The Canadian medical device market is one of the largest in the world. Its value is projected to increase to $9.2 billion in 2024 from $7.2 billion in 2019. Canada also has an ageing population with the number of persons aged 65 and above seen to make up 23% of its total population in 2031.
THE LARGER TREND
This latest regulatory clearance follows the approvals issued by the US Food and Drug Administration to the same Lunit AI solutions last year. CEO Brandon Suh said they will make a “full-fledged entry” into the North American market following these approvals.
In other news, Lunit just filed last week a registration statement with the Korean Exchange for an initial public offering in July. The company plans to issue a total of 1.12 million shares worth between $34-$38 apiece. Ahead of the IPO, Lunit launched in November a fundraiser where it raised $61 million.