Innovative medical devices that address the treatment limitations in domestic and international medical fields are emerging in Korea.
Technologies such as the world's first eye cooling anesthesia that precisely cools and anesthetizes in 10 seconds, smart contact lenses that can monitor intraocular pressure, artificial intelligence (AI) solutions that predict embryo development and pregnancy possibilities, and high-intensity focused ultrasound devices that enhance the delivery effect of pancreatic cancer drugs are representative examples. All of them are fruits of challenges undertaken by domestic corporations and researchers, with the government's support as well. They plan to expand beyond Korea to the global market.
The Inter-Agency Advanced Medical Device Research and Development Project Group (hereinafter referred to as the Project Group) held a performance report meeting for this year's top 10 representative projects at YTN Newsquare Media Hall on the 11th.
The Project Group is a national agency jointly established by the Ministry of Health and Welfare, the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, and the Ministry of Food and Drug Safety in 2020 to support the development of domestic innovative medical devices. Over six years, from 2020 to 2025, a total of 12 trillion won will be invested to support the entire cycle from medical device technology research and development to clinical trials, authorization, and commercialization.
The performance report meeting recognizes outstanding results from research projects supported by this program and shares major achievements, marking its third event this year. The 10 representative projects were selected based on a comprehensive evaluation of the results submitted by 46 corporations according to three core indicators: the appropriateness of research and development execution, the impact on technology and medical fields, and the social and economic impact.
◇ Solving disease treatment challenges using AI and digital technology
The 10 representative projects selected this time include ▲ emergency cooling anesthesia devices (Recens Medical) ▲ digital therapy devices for improving mild cognitive impairment (EmoCog) ▲ smart contact lenses for real-time monitoring of glaucoma intraocular pressure (HwaibioMed) ▲ AI embryo analysis digital therapy devices for increasing the success rate of infertility treatment (Kai Health) ▲ digital therapy devices for customized treatment of refractory visual impairment for brain disease patients (New Naps) ▲ fully automated AI cell analysis cancer diagnosis devices (Noul) ▲ high-intensity focused ultrasound medical devices capable of enhancing the delivery effect of pancreatic cancer drugs (IMGT) ▲ mobile tomosynthesis (JPI Healthcare) ▲ minimally invasive catheters for myocardial treatment (Taumedical) ▲ AI-based patch-type wearable heart disease management systems (Cearce Technology).
Recens Medical has developed the world's first technology that precisely cools and anesthetizes the eye in 10 seconds. This method uses no drugs, only accurately adjusting the temperature to anesthetize the nerves in an instant. Simply contacting the treatment area for about 10 seconds induces anesthesia without cellular damage or drug side effects. The traditional chemical anesthesia method using medications takes more than a minute to establish an anesthetic effect, resulting in low efficiency and side effects such as dry eyes and irritation.
Kim Geon-ho, CEO of Recens Medical, noted, "Compared to existing methods, 80% of patients prefer this technology, and we have received approval through the U.S. Food and Drug Administration's De Novo review process. We are currently successfully completing clinical trials and introducing the technology at various conferences, including regulatory approval conferences in the U.S." De Novo is the FDA’s licensing system for new medical devices without similar prior technologies.
HwaibioMed has developed smart contact lenses that can continuously measure intraocular pressure for glaucoma. The existing method of measuring intraocular pressure is conducted as a one-time test in hospitals, making it difficult to consistently measure fluctuating intraocular pressure. To improve this, they collaborated with Pohang University of Science and Technology (POSTECH) Department of Materials Science and Engineering, Yonsei University Severance Hospital’s ophthalmology department, and the largest contact lens manufacturer in Korea, Interojo.
The research team aimed to develop a wireless glaucoma intraocular pressure diagnosis system and has completed the development of sensors and materials for intraocular pressure detection. The existing technology for measuring intraocular pressure based on smart contact lenses has limitations as it requires the device to be attached to the skin while hospitalized.
HwaibioMed is optimizing the process of integrating electronic components, antennas, and electrodes that are embedded in smart contact lenses. They are currently preparing for safety and regulatory tests for practical application. The research team plans to complete non-clinical evaluations within the year and aims to commercialize the smart contact lens system by 2027.
Kai Health, a medical artificial intelligence (AI) company, has developed the AI software medical device Vita Embryo, which analyzes embryos generated during infertility treatments. The success of infertility treatment relies on selecting high-quality embryos, which previously depended on the subjective judgment of medical personnel. As a result, the average success rate of infertility procedures has remained around 30%.
To solve this problem, Kai Health has developed AI-based embryo selection technology. The trained AI evaluates the quality of embryos and assigns scores, which the medical personnel use as a reference for final embryo selection. This allows for a more objective and precise selection of embryos, increasing the success rate of infertility treatment. As the success rate increases, the number of procedures required decreases, alleviating the economic burden and positively impacting the low birthrate issue.
This technology has been designated as a class 3 medical device by the Ministry of Food and Drug Safety and underwent clinical trials with Bundang Seoul National University Hospital last year. This year, commercialization is planned following reviews by the Health Insurance Review and Assessment Service and the Korea Institute of Health and Social Affairs. Preparations are also underway for entry into the U.S. market, with plans to conduct clinical trials and target FDA approval in 2026, expecting to start generating sales in 2027.
New Naps has developed an AI-based customized treatment technology that improves visual impairment due to neurological complications. About 20% of stroke patients experience damage to part of their vision due to brain injury. When there is a visual impairment in the left brain, for example, the right eye's field of vision becomes restricted. New Naps adopts an approach that activates the neural circuits of the brain rather than the eyes, encouraging new vision acquisition through repeated training in visual perception learning.
Using AI, personalized training tasks are designed for each patient, with the level of difficulty and training location automatically adjusted. By applying virtual reality (VR) technology, training can be conducted regardless of location, and a real-time monitoring and feedback system is also provided. Received approval from the Food and Drug Safety Agency in April last year, it was designated as an innovative medical technology by the Ministry of Health and Welfare in June of the same year, with prescriptions beginning at Asan Medical Center. Currently, preparations are underway for market expansion in Korea and entry into Germany and Japan through CE certification, and it is highly likely to receive approval through the FDA's De Novo review process.
The digital cognitive therapy device Cogtera developed by EmoCog has obtained European medical device approval, accelerating its entry into the global market. Cogtera is designed for the elderly to perform interactive cognitive training directly. It analyzes the areas of cognitive decline in users and offers tailored difficulty levels. Considering both cost-effectiveness and efficacy, it can be used in conjunction with drug therapy. This allows for comprehensive assessment of continued treatment participation and effectiveness improvements over the long term. Based on the clinical trials conducted at Gachon University Gil Medical Center, it became the first in Korea to obtain medical device approval in Europe and received innovative medical device approval in December last year.
IMGT is a biotech venture founded in 2010 by Professor Lee Hak-jong of the Department of Radiology at Bundang Seoul National University Hospital. It developed the world's first high-intensity focused ultrasound therapeutic device that enhances the delivery effect of pancreatic cancer drugs by integrating focused ultrasound technology and nanoparticle technology.
Kim Beom-min, head of the Project Group, said, "The top 10 representative projects were selected through close cooperation between the government agencies and the Project Group, aiming to solve social issues and lead the global market with innovative medical devices. We will continue to enhance support to ensure that the government's R&D support drives the development of the medical device industry and leads to results that citizens can directly experience. The government stated, "We will continue to strengthen support so that the government's R&D support can drive the development of the medical device industry and lead to results that citizens can directly experience."
The Project Group plans to set up promotional booths for the top 10 representative projects at the 40th International Medical Device and Hospital Equipment Exhibition (KIMES 2025), which will be held in March, and display performance posters and equipment to provide product demonstration opportunities for medical device stakeholders.