The medical artificial intelligence (AI) market is experiencing explosive growth, with industry leaders Lunit and Vuno facing a pivotal year to prove their performance. While the number of related approvals in the market has surged, concerns remain about the financial stability and international commercialization success of these frontrunners.
According to data from the Ministry of Food and Drug Safety, the number of approvals, certifications, and notifications for AI-based software medical devices increased from 62 in 2023 to 108 in 2024 and 157 in 2025, marking a 2.5-fold rise over three years. This growth is significant compared to just four approvals in 2018, 13 in 2019, and 50 in 2020, indicating a substantial application of these technologies in clinical settings. In the first quarter of this year alone, an additional 55 approvals were recorded, continuing the upward trend.
Amid this rapid market expansion, Lunit and Vuno are grappling with financial risks and challenges related to overseas approvals, which have become their primary obstacles this year.
Lunit reported record annual sales of 83.1 billion won last year and has set a target of over 80 billion won in sales for this year. The company aims to achieve profitability by 2027 and is working to create a revenue structure through expanding global partnerships and offering high-margin subscription-based (SaaS) products that charge monthly fees based on usage.
Despite recent financial risk concerns, Lunit alleviated some anxiety by successfully completing a capital increase. The company achieved a subscription rate of 104.7% from existing shareholders in a capital increase worth 211.5 billion won, effectively securing capital and boosting expectations for financial stability. Lunit believes it has laid the groundwork to reduce the debt burden that increased due to the acquisition of Bolpara. Market attention is now focused on Lunit's potential for profitability this year.
In contrast, Vuno reported sales of 34.8 billion won last year, with an operating loss of 4.9 billion won. While its revenue has grown and losses have decreased, the company faced a setback when its key product, VunoMed DeepCARS, received a Not Substantially Equivalent (NSE) determination from the FDA for its 510(k) application, presenting a significant challenge. Vuno plans to reinforce its clinical and performance data for a resubmission, but this has delayed its initial timeline.
The recent FDA decision has particularly painful implications, as it effectively means missing the entry point for the 2027 fiscal year NTAP. Given the structure requiring FDA approval and entry into U.S. public insurance, any delays in reimbursement schedules could slow the pace of business expansion, according to market observers. Vuno is preparing for resubmission while diversifying into Europe and the Middle East, but this year's performance of DeepCARS is expected to be a critical turning point for the company's valuation.
Vuno CEO Lee Ye-ha stated on the company's website on May 4, "This FDA decision does not negate the core technology or clinical value of DeepCARS." He added, "It should be interpreted as a request for additional evidence of equivalence with existing products," emphasizing that the process has clarified the clinical standards and expectations in the U.S. market, and the company plans to quickly reorganize its clinical data for resubmission.
Despite Lee's reassurances, Vuno's stock has plummeted following the FDA's decision, dropping more than 20% immediately after the announcement on May 4. As of 10:15 a.m. on May 11, the stock price had fallen to 12,240 won, a decline of about 30% in just one week.
Industry insiders noted, "Lunit must prove its profitability based on capital expansion, while Vuno faces the challenge of reapplying for U.S. approval and redesigning its NTAP strategy to rebuild its growth narrative."
* This article has been translated by AI.
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