South Korean AI startup Lunit has received regulatory approval from Health Canada for its AI solutions for radiology.
According to a press release, both the INSIGHT CXR chest X-ray solution and the INSIGHT MMG mammography software are now cleared for commercial release in Canada.
INSIGHT CXR can detect 10 of the most common breast anomalies with an accuracy of 97% to 99%, while INSIGHT MMG analyzes mammography images with an accuracy of 96%.
WHY IT MATTERS
The Canadian medical device market is one of the largest in the world. Its value is expected to increase from $7.2 billion in 2019 to $9.2 billion in 2024. Canada also has an aging population, with those aged 65 and over projected to make up 23% of the total population in 2031.
THE BIGGER TREND
This latest regulatory approval follows approvals issued by the The US Food and Drug Administration has deployed the same Lunit AI solutions for the past year. CEO Brandon Suh said that after these approvals they will make a “full entry” into the North American market.
In other news, just last week, Lunit filed a registration statement with the Korean Stock Exchange for a July IPO. The company plans to issue a total of 1.12 million shares at between $34 and $38 a share. Ahead of the IPO, Lunit launched a fundraiser in November, raising money $61 million.