{"id":878,"date":"2022-06-20T00:00:00","date_gmt":"2022-06-20T00:00:00","guid":{"rendered":"https:\/\/www.lunit.io\/media-hub\/lunit-ai-solution-for-radiology-receives-health-canada-nod-for-commercial-use\/"},"modified":"2025-10-15T13:31:32","modified_gmt":"2025-10-15T13:31:32","slug":"lunit-ai-solution-for-radiology-receives-health-canada-nod-for-commercial-use","status":"publish","type":"media-hub","link":"https:\/\/www.lunit.io\/en\/media-hub\/lunit-ai-solution-for-radiology-receives-health-canada-nod-for-commercial-use\/","title":{"rendered":"Lunit AI Solution for Radiology Receives Health Canada Nod for Commercial Use"},"content":{"rendered":"<ul>\n<li>\n<p>Lunit\u2019s AI solutions for radiology received medical device licenses from Health Canada<\/p>\n<\/li>\n<li>\n<p>Following last year\u2019s FDA clearance, Lunit\u2019s Canadian commercial approval to accelerate expansion in the North American market<\/p>\n<p><\/p>\n<\/li>\n<\/ul>\n<p>Lunit today announced that it received commercial approval in Canada for Lunit INSIGHT, the company\u2019s AI solution suite for radiology. On June 14, Canadian medical device regulator Health Canada issued class 2 medical licenses for Lunit\u2019s AI solution for chest x-ray, \u2018Lunit INSIGHT CXR\u2019 and \u2018Lunit INSIGHT MMG,\u2019 AI solution for mammography.<\/p>\n<p>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\u2019s 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.<\/p><figcaption>\n<p><img decoding=\"async\" src=\"\/en\/wp-content\/uploads\/EDITOR\/dabe1e1b-e4e3-4ffd-81c5-a8c3de9895d4.png#1309\">\u25b2Lunit INSIGHT CXR<\/p>\n<\/figcaption><p>Along with Lunit\u2019s AI solution for chest x-rays, Lunit INSIGHT MMG is one of the company\u2019s 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.<\/p><figcaption>\n<p><img decoding=\"async\" src=\"\/en\/wp-content\/uploads\/EDITOR\/c1cadef0-7185-4b7a-883b-87e79632e90d.png#1310\">\u25b2Lunit INSIGHT MMG<\/p>\n<\/figcaption><p>Following last year\u2019s FDA approval in the U.S., Lunit\u2019s commercial approval in Canada signals the company\u2019s continued expansion in the North American market.<\/p>\n<p>As the eighth largest in the world, the Canadian medical device market is growing rapidly along with the country\u2019s 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<a href=\"#_ftn1\" target=\"_blank\"><sup>[1]<\/sup><\/a>.<\/p>\n<p>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%<a href=\"#_ftn2\" target=\"_blank\"><sup>[2]<\/sup><\/a>.<\/p>\n<p>\u201cThis 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,\u201d said Brandon Suh, CEO of Lunit. \u201cAs our AI technology continues to gain global recognition, we will do our best to become a global leader in the medical devices field.\u201d<\/p>\n<p><\/p>\n<hr>\n<p><a href=\"#_ftnref1\" target=\"_blank\"><sup>[1]<\/sup><\/a> \u201cPopulation Projections for Canada,\u201d Statistics Canada (2019.09)<\/p>\n<p><a href=\"#_ftnref2\" target=\"_blank\"><sup>[2]<\/sup><\/a> \u201cCanada Medical Devices Report,\u201d Fitch Solutions (2020.2Q)<\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"template":"","media-hub-type":[36],"class_list":["post-878","media-hub","type-media-hub","status-publish","hentry","media-hub-type-cancer-screening"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Lunit AI Solution for Radiology Receives Health Canada Nod for Commercial Use - Lunit<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.lunit.io\/en\/media-hub\/lunit-ai-solution-for-radiology-receives-health-canada-nod-for-commercial-use\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Lunit AI Solution for Radiology Receives Health Canada Nod for Commercial Use - Lunit\" \/>\n<meta property=\"og:description\" content=\"Lunit\u2019s AI solutions for radiology received medical device licenses from Health Canada Following last year\u2019s FDA clearance, Lunit\u2019s 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\u2019s AI solution suite for radiology. 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