SEOUL – South Korea’s medical artificial intelligence (AI) sector has reached a significant turning point, with more than 100 new AI-based medical devices being approved annually. Once limited to simple image analysis, these technologies are now rapidly penetrating high-complexity diagnostic and predictive medical fields.
According to data from the Korean Society of Medical AI and the Ministry of Food and Drug Safety (MFDS) released on April 12, 2026, the cumulative number of approved AI medical devices has reached 549. The industry has shown exponential growth since the first approval in 2018; the number of annual approvals jumped from a mere 5 in 2018 to 118 in 2024, and further to 130 in 2025. With 30 approvals already recorded in the first quarter of this year, the trend is expected to surpass the 100-mark easily for the third consecutive year.
The landscape of AI application has shifted dramatically. In the late 2010s, AI was primarily used as an assistant for reading chest X-rays or brain MRIs to detect nodules or stroke. Today, the technology covers 29 different medical specialties. Cardiology leads the field with 81 approved devices, followed by Pulmonology (74) and Neurology/Neurosurgery (65). Notably, 21.1% of these devices are classified as Class 3 (high-risk), indicating that AI is now taking on critical roles in serious clinical decision-making.
The evolution of these tools is also noteworthy. Beyond simple detection, current solutions include AI that predicts cardiac arrest based on vital signs, digital therapeutics for insomnia, and even the world’s first generative AI medical device approved earlier this month, which automatically drafts preliminary medical reports by analyzing X-ray images.
Leading the charge in the domestic market is JLK with 34 cumulative approvals, followed by GE Healthcare Korea (32), Demant Korea (28), Vuno (27), and Deepnoid (24).
However, experts suggest that the industry still faces hurdles. Park Chang-min, President of the Korean Society of Medical AI and Professor at Seoul National University, noted, "While the volume of approvals is encouraging, only 49 products have received temporary insurance coverage due to a lack of robust clinical evidence and a lagging reimbursement system." He emphasized that to compete with global tech giants, South Korea must consider policy support such as providing "AI adoption incentives" to medical institutions, similar to models seen in Japan.
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