Photo courtesy of JLK
Back-to-back news over the past few years since the recent pandemic reported on the aggressive global expansion of South Korean companies in the medical imaging AI space.
From securing regulatory approvals to closing national and regional-scale distribution and partnerships, these innovators (such as Lunit, VUNO, and Coreline Soft) seemed to have convinced health systems worldwide of the promising benefits of their AI solutions that assist with accurate and quick disease diagnosis – with several global studies done backing these claims.
Just within last year, for example, JLK, one of South Korea's medical AI pioneers, secured not just one, two, or three clearances from the globally authoritative regulator, the United States Food and Drug Administration, but four. Founded in 2014, JLK was the first medical AI company in South Korea to be listed on the South Korean stock exchange KOSDAQ in 2019.
Mobihealth News caught up with JLK CEO Dong-Min Kim to shed light on this seeming global race among South Korean companies in medical AI trying to cover ground worldwide. He also shared their plans for the new year and where he thinks imaging AI is headed in the coming months.
Q. JLK is planning to apply for more US FDA clearances this year, particularly for your line of stroke AI solutions. With the many stroke imaging solutions available in the world's biggest market for medical AI solutions, how does JLK intend to set itself apart from the pack?
A. In January 2025, JLK received FDA clearance for JLK-ICH, our intracranial haemorrhage detection solution, bringing our total to five FDA-approved solutions. Additionally, our subdural hematoma detection solution and AI medical hub platform are currently under FDA review. There are also plans to apply for further FDA clearances for other stroke-related AI solutions.
JLK's differentiation strategy lies in accuracy, speed, and user-friendly workflows. We develop clinically validated algorithms that align with global medical standards, providing reliable tools that medical professionals can trust. Furthermore, we maximise accessibility and ease of use in clinical settings to seamlessly integrate our solutions into global healthcare workflows.
With over 13 AI solutions based on CT and MRI imaging for stroke, we have a significant competitive edge and a unique position as a global leader in stroke AI. Our AI solutions are optimised for the entire stroke care continuum, from the patient's arrival at the hospital to diagnosis, treatment, and rehabilitation. These solutions also allow medical professionals to access stroke patient AI data anytime. Through our mobile application Snappy, they can also use features like chat and alerts to enhance treatment and survival rates.
These strengths will drive our expansion in global market share.
Q. Other Korean medical AI companies have also been expanding to the US in recent years. How has the American market's reception of Korean imaging AI been? And what are the major appeal factors of this market to Korean companies?
A. The American market has been increasingly open and receptive to Korean medical AI technologies. With the reliability and efficacy of these solutions validated through FDA approvals, acceptance by hospitals and medical institutions has grown significantly. As the largest healthcare market globally, accounting for 40% of the global medical sector, success in the US translates directly into enhanced global competitiveness, making it highly attractive for Korean companies.
Korean medical AI stands out for its cost-efficiency and technological innovation, which provide a strong competitive edge. Additionally, the US insurance system, dominated by private insurance, offers significantly higher reimbursement rates compared to Korea, ensuring profitability – an appealing factor for the industry.
Driven by these opportunities, Korean medical AI companies are accelerating their expansion into the US, and their influence is expected to grow steadily.
Q. In taking on this global expansion route, what have you reflected over the past years since inception about JLK's growth and its capacity to go beyond Korea? How was its readiness to go global gauged?
A. Over the past few years, JLK has focused on technological innovation and building a solid foundation for global expansion. Through securing regulatory approvals such as FDA clearances in the US, PMDA (Pharmaceuticals and Medical Devices Agency) in Japan, and others across various countries, we have established trust in the global market.
By proactively pursuing regulatory compliance in key markets, we have developed an optimal strategy to meet the requirements of health authorities, which helped significantly decrease the time required for approval per submission. This aggressive and efficient approach to regulatory approvals has been recognised within the industry, setting an example of achieving multiple approvals within a short timeframe.
Additionally, we have ensured compatibility with diverse medical devices and systems, including EMR, PACS, and HIS, enabling seamless integration into any medical institution.
JLK’s solutions are already being used across Asia, Europe, the Middle East, and North America. We have prepared thoroughly for global expansion through localised technical support and strategic partnerships. These experiences have provided us with a definitive competitive edge as we continue to extend our reach into international markets.
Q. What can you tell us more about JLK's expansion plans in 2025, both in Korea and the US? How about in other regional markets? Any new imaging AI offering in the pipeline?
A. In 2025, JLK plans to expand its market share in the US, Japan, and Korea while also preparing for entry into emerging markets such as Europe and Southeast Asia. Specifically, in the US, we aim to apply for FDA clearance for six additional stroke solutions and secure at least four approvals within the year. In Japan, we plan to complete PMDA applications for eight solutions and obtain approvals for at least four. As in previous years, our focus remains on establishing a strong presence in these key markets while actively pursuing reimbursement approvals to make 2025 a pivotal year for generating overseas revenue.
We are also continuously developing additional solutions in the stroke domain, which will be released sequentially. Furthermore, we are advancing the global launch of our AI-based medical data hub platform. This platform extends beyond imaging AI by integrating and analysing medical data, enhancing the efficiency of hospitals and medical professionals. Through these initiatives, JLK aims to solidify its leadership in the medical AI sector globally.
Q. Last year 2024 was a big year for AI adoption in healthcare. In 2025, where do you see imaging AI going and how do you think the healthcare industry, particularly hospitals and doctors, are going to use them? Do we still see huge demand or faltering interest in medical imaging AI?
A. In 2025, the medical imaging AI community is expected to develop more precise and comprehensive solutions. Particularly, AI will become more accurate in providing diagnosis of various diseases. AI will continue to improve the quality of medical services, the demand for which the medical AI industry expects to rise. Moreover, the scope of AI applications is expanding, now assisting with improving disease prognosis.
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Kim's responses have been edited for clarity and brevity.