Hello, JNPMEDI has prepared medical device clinical trial plans approved in May 2025.
Shall we take a closer look? ๐
In May 2025, the Ministry of Food and Drug Safety (MFDS) approved a total of 16 clinical trials, including 10 for digital medical devices. These approvals covered a wide spectrum of technologiesโAI-based imaging software, smart insulin pens, cognitive function enhancement devices, biosignal analysis systems, and rehabilitation and mental health therapy software. The indications were also broadly distributed, including depression, diabetes, insomnia, cognitive impairment, and management of side effects during cancer treatment. This trend shows that the clinical use of digital medical devices is expanding from specific specialties to the broader clinical landscape.
Among these, the emergence of digital therapeutics based on non-pharmacological treatment approaches is particularly noteworthy. A number of products designed to supplement or assist the limitations of drug therapy have been approved, with ongoing efforts to rigorously validate their utility and effectiveness in real-world clinical settings. The movement to evaluate the efficacy of digital therapeutic methods for chronic and complex diseases like sleep disorders, depression, mild cognitive impairment, and dementia continues to expand.
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One notable case is the VR-based software trial approved on May 13, an exploratory study evaluating how digital therapy may affect symptoms in patients with chronic insomnia. This single-site, single-arm, prospective trial provides participants with VR content for a defined period and assesses pre- and post-treatment differences in sleep patterns, sleep quality, and self-reported outcomes. Although no control group is included, the study is intentionally exploratoryโaimed at detecting early efficacy signals ahead of a future confirmatory trial.
This trial represents an important step in exploring new treatment options for insomnia beyond medication or standard cognitive behavioral therapy. It also serves as a clinical validation process to determine whether VR technology can yield meaningful results as a therapeutic intervention, laying the foundation to confirm both its technological potential and clinical value.
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The case also exemplifies real-world application of the MFDSโs recently issued โGuideline on Approval and Review of Digital Medical Devices Using Virtual-Convergence Technology.โ The guideline outlines required evaluation criteria and safety considerations when VR, AR, and MR are used for diagnosis, treatment, monitoring, or rehabilitation, with multi-layered requirements for preventing UI confusion, ensuring cybersecurity, and maintaining data integrity.
To date, a total of nine VR-based digital medical device clinical trials have been approved in Korea, covering diverse fields such as cognitive disorders, emotional disorders, stroke rehabilitation, and balance function analysis. This clinical trial is symbolic of a trend where virtual reality technology is moving beyond simple experiential content to establish itself as a genuine therapeutic tool.
These changes are accelerating the trend of digital medical devices functioning as independent therapeutic interventions rather than mere auxiliary technologies in clinical settings, and are expected to have a significant impact on the entire approval and review system in the future.
We will continue to provide insights into key clinical trial approval trends and meaningful case studies.
Thank you! ๐
๐ References
Hello, JNPMEDI has prepared medical device clinical trial plans approved in May 2025.
Shall we take a closer look? ๐
In May 2025, the Ministry of Food and Drug Safety (MFDS) approved a total of 16 clinical trials, including 10 for digital medical devices. These approvals covered a wide spectrum of technologiesโAI-based imaging software, smart insulin pens, cognitive function enhancement devices, biosignal analysis systems, and rehabilitation and mental health therapy software. The indications were also broadly distributed, including depression, diabetes, insomnia, cognitive impairment, and management of side effects during cancer treatment. This trend shows that the clinical use of digital medical devices is expanding from specific specialties to the broader clinical landscape.
Among these, the emergence of digital therapeutics based on non-pharmacological treatment approaches is particularly noteworthy. A number of products designed to supplement or assist the limitations of drug therapy have been approved, with ongoing efforts to rigorously validate their utility and effectiveness in real-world clinical settings. The movement to evaluate the efficacy of digital therapeutic methods for chronic and complex diseases like sleep disorders, depression, mild cognitive impairment, and dementia continues to expand.
One notable case is the VR-based software trial approved on May 13, an exploratory study evaluating how digital therapy may affect symptoms in patients with chronic insomnia. This single-site, single-arm, prospective trial provides participants with VR content for a defined period and assesses pre- and post-treatment differences in sleep patterns, sleep quality, and self-reported outcomes. Although no control group is included, the study is intentionally exploratoryโaimed at detecting early efficacy signals ahead of a future confirmatory trial.
This trial represents an important step in exploring new treatment options for insomnia beyond medication or standard cognitive behavioral therapy. It also serves as a clinical validation process to determine whether VR technology can yield meaningful results as a therapeutic intervention, laying the foundation to confirm both its technological potential and clinical value.
The case also exemplifies real-world application of the MFDSโs recently issued โGuideline on Approval and Review of Digital Medical Devices Using Virtual-Convergence Technology.โ The guideline outlines required evaluation criteria and safety considerations when VR, AR, and MR are used for diagnosis, treatment, monitoring, or rehabilitation, with multi-layered requirements for preventing UI confusion, ensuring cybersecurity, and maintaining data integrity.
To date, a total of nine VR-based digital medical device clinical trials have been approved in Korea, covering diverse fields such as cognitive disorders, emotional disorders, stroke rehabilitation, and balance function analysis. This clinical trial is symbolic of a trend where virtual reality technology is moving beyond simple experiential content to establish itself as a genuine therapeutic tool.
These changes are accelerating the trend of digital medical devices functioning as independent therapeutic interventions rather than mere auxiliary technologies in clinical settings, and are expected to have a significant impact on the entire approval and review system in the future.
We will continue to provide insights into key clinical trial approval trends and meaningful case studies.
Thank you! ๐
๐ References