South Korea’s medical artificial intelligence market is expanding rapidly, with government approvals rising more than 2.5 times over the past three years, according to the Ministry of Food and Drug Safety. The technology is also evolving beyond diagnostic support to systems that can generate preliminary findings for imaging readers, industry officials say.
The ministry said approvals, certifications and filings for AI-based software medical devices climbed from 62 cases in 2023 to 108 in 2024 and 157 in 2025. Another 55 cases were added in the first quarter of this year, it said.
That compares with 4 cases in 2018, 13 in 2019 and 50 in 2020, underscoring how quickly the market has grown in less than a decade. The industry attributes the broader uptake to results from early leaders such as Lunit and VUNO, along with progress by newer entrants.
Lunit said it received domestic approval last year for its 3D breast tomosynthesis AI image analysis solution, “Lunit INSIGHT DBT.” The product received U.S. Food and Drug Administration premarket approval in November 2023 and is being supplied through major U.S. imaging centers including SimonMed Imaging and Resolute, the company said.
Lunit reported consolidated revenue of 83.1 billion won last year, up 53% from 54.2 billion won a year earlier, its highest annual total. Overseas revenue was 76.8 billion won, or 92% of the total, up 61% from 47.8 billion won. Fourth-quarter revenue rose 32% to 26.5 billion won from 20.0 billion won a year earlier.
VUNO said it expanded its lineup after receiving ministry approval for “VUNO Med-DeepECG Kidney,” an AI-based electrocardiogram analysis software designed to screen for declining kidney function. The company said the deep-learning algorithm analyzes 12-lead ECG data to provide noninvasive, rapid and accurate screening.
VUNO posted revenue of 34.8 billion won last year, up 34.4% from the previous year, a record. Sales of its flagship AI-based cardiac arrest prediction device, “VUNO Med-DeepCARS,” rose 18% to 25.7 billion won. Revenue from its AI-based ECG measurement device “Hativ” also increased to 1.9 billion won, the company said.
Other companies, including Noeul and 3billion, are also contributing to market growth by targeting areas not dominated by the leading firms, such as AI-based blood and cancer diagnostics and AI-based rare disease diagnosis, the report said.
In contrast, the number of approvals for medical AI clinical trial plans has declined, the ministry said, falling from 59 in 2023 to 56 in 2024 and 38 in 2025. Seven plans were approved in the first quarter of this year.
A ministry official said the drop reflects the Digital Medical Products Act, under which data-based clinical trials are exempt from plan approval. “Because AI software often relies on data-based clinical studies, there are likely many trials conducted without ministry approval,” the official said.
The ministry said approvals, certifications and filings for AI-based software medical devices climbed from 62 cases in 2023 to 108 in 2024 and 157 in 2025. Another 55 cases were added in the first quarter of this year, it said.
That compares with 4 cases in 2018, 13 in 2019 and 50 in 2020, underscoring how quickly the market has grown in less than a decade. The industry attributes the broader uptake to results from early leaders such as Lunit and VUNO, along with progress by newer entrants.
Lunit said it received domestic approval last year for its 3D breast tomosynthesis AI image analysis solution, “Lunit INSIGHT DBT.” The product received U.S. Food and Drug Administration premarket approval in November 2023 and is being supplied through major U.S. imaging centers including SimonMed Imaging and Resolute, the company said.
Lunit reported consolidated revenue of 83.1 billion won last year, up 53% from 54.2 billion won a year earlier, its highest annual total. Overseas revenue was 76.8 billion won, or 92% of the total, up 61% from 47.8 billion won. Fourth-quarter revenue rose 32% to 26.5 billion won from 20.0 billion won a year earlier.
VUNO said it expanded its lineup after receiving ministry approval for “VUNO Med-DeepECG Kidney,” an AI-based electrocardiogram analysis software designed to screen for declining kidney function. The company said the deep-learning algorithm analyzes 12-lead ECG data to provide noninvasive, rapid and accurate screening.
VUNO posted revenue of 34.8 billion won last year, up 34.4% from the previous year, a record. Sales of its flagship AI-based cardiac arrest prediction device, “VUNO Med-DeepCARS,” rose 18% to 25.7 billion won. Revenue from its AI-based ECG measurement device “Hativ” also increased to 1.9 billion won, the company said.
Other companies, including Noeul and 3billion, are also contributing to market growth by targeting areas not dominated by the leading firms, such as AI-based blood and cancer diagnostics and AI-based rare disease diagnosis, the report said.
In contrast, the number of approvals for medical AI clinical trial plans has declined, the ministry said, falling from 59 in 2023 to 56 in 2024 and 38 in 2025. Seven plans were approved in the first quarter of this year.
A ministry official said the drop reflects the Digital Medical Products Act, under which data-based clinical trials are exempt from plan approval. “Because AI software often relies on data-based clinical studies, there are likely many trials conducted without ministry approval,” the official said.
* This article has been translated by AI.
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