The Apple Watch, a wearable device released by Apple, has an 'atrial fibrillation' function that can check the heartbeat rhythm. The technology has been listed as 510k, a pre-market approval class for medical devices by the US Food and Drug Administration (FDA). Most of the products in the artificial intelligence medical market have been approved for the corresponding class, but the related market size alone has quadrupled to about 20 trillion won in three years, so there are voices that domestic companies should actively consider entering the market.
According to market research institutes on the 15th of March, the global artificial intelligence medical market went through a period of rapid growth from 5.8 trillion won ($4.5 billion) to 20.3 trillion won ($15.6 billion) in 2020. In 2025, the market size is expected to grow to 47 trillion won.
About half of the AI medical market, or 47%, is the US market. Global big tech companies, such as Alphabet, the parent company of Apple and Google, are virtually monopolizing the market. According to data released by the FDA, it was found that there were 91 medical devices related to artificial intelligence and machine learning health solutions that were approved by the FDA from January to October of last year.
인공지능 의료기기 시장 규모 /식품의약품안전처, 여성경제신문 재구성 In particular, in the case of artificial intelligence medical devices, Central and South America, excluding Brazil, is the largest export market in the industry. An official from a domestic medical device company said in Women's Economic Daily and Monetary explained that, " Most countries such as Europe, Japan, Korea and the United States have their own medical device certification system, but in the case of Central and South American countries, the US FDA approval is replaced with import certification reference documents."
Therefore, if the AI medical device developed by the company receives FDA approval, the company can preoccupy the so-called 'One Plus One (1+1)' market not only in the United States but also in Central and South America. In particular, Korea has the advantage of being able to cooperate with the health authorities of Latin American countries through the Korea International Cooperation Agency (KOICA) support program.
In order for artificial intelligence medical devices to cross the threshold for export to the United States and Central and South America, they must receive a '510k' class. Food and Drug Administration official said that, "This class means to prove that the medical device that the device developer intends to distribute is safe through item inspections such as purpose of use, technical characteristics, and performance tests, and it is possible to market the situation in the United States or in countries that apply FDA standards."
Companies that receive FDA product approval in Korea are narrowed down to Lunit, Huron, Coreline, Clarifai, iMedicine, and AIDOT. It has developed artificial intelligence medical devices for breast cancer, Parkinson's disease, and cervical cancer, respectively.
The industry believes that receiving FDA approval for a domestic artificial intelligence medical device venture company means that they can expect to advance into the Central and South American market and to make good progress in the medical device market.
CEO of AIDOT, Jae-hoon Jeong said, "In the case of our company, we contacted the Ministry of Health of Bolivia through the KOICA program, and the Ministry of Health is also pleased with the export of our products, so we are thinking that we will achieve significant concrete results within the first half of this year."
Another medical device company also added that, "If a product is approved or registered by the U.S. Food and Drug Administration, it is relatively easy to enter Central and South American regions such as Brazil and Argentina, and the AI medical market is a golden opportunity for Korean companies to enter the medical device market. "
Women's Economic Daily / 15th. Mar. 2023. / Reporter Hyun-woo Kim
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