Hello, JNPMEDI has prepared medical device clinical trial plans approved in June 2025.
Shall we take a closer look? ๐
In June 2025, the Ministry of Food and Drug Safety (MFDS) approved a total of 14 medical device clinical trials, including 5 for digital medical devices. This month saw approvals for a diverse range of indications, such as an ultrasound stimulation system aimed at opening the blood-brain barrier in dementia patients, digital technology-based biosignal analysis, and tissue-restoring biomaterials for facial wrinkle improvement.
Of particular note this month is the ultrasound stimulation clinical trial for opening the blood-brain barrier (BBB) in Alzheimer's dementia patients. This exploratory clinical trial involves injecting a contrast agent (Sonovue) followed by using a focused ultrasound stimulation system (NS-US200) to target the left dorsolateral prefrontal cortex. The study aims to evaluate the temporary opening of the BBB, along with the efficacy and safety of the procedure.
The blood-brain barrier acts as a biological shield that blocks external substances from entering the brain, historically serving as a major hurdle for neurological disease treatments. This trial evaluates an innovative ultrasound technology that non-invasively and temporarily opens this barrier, aiming to enhance drug delivery for brain disorders. Unlike existing methods like TMS or DBS, the key technical differentiator is its ability to stimulate the brain through the skull using ultrasound, allowing for repeated, non-invasive use without electrical stimulation.
Focused ultrasound stimulation systems primarily target central nervous system disorders like depression, dementia, and Parkinson's disease, with 101 related products already approved, indicating active research. However, this specific trial is considered a highly novel approach for dementia treatment. Its design phase demands multi-layered safety evaluations, including ultrasound output accuracy, penetration depth, and focal point precision, alongside biocompatibility of scalp contact materials and electromagnetic safety. The Mini-Mental State Examination (MMSE) is suggested as a potential tool for measuring efficacy.
The MFDS is also establishing safety and efficacy evaluation standards for ultrasound-mediated BBB opening devices through its guidelines. The results of this clinical trial are expected to serve as a crucial benchmark for future regulatory directions. Showing potential to overcome drug delivery limitations in various neurological diseases beyond just dementia, this endeavor is highly evaluated not only for its clinical significance but also for its technological and policy implications.
Beyond this, a meticulously designed clinical trial in the aesthetic medical device sector for improving fine lines around the eyes was also approved this month. This exploratory trial evaluates the efficacy and safety of tissue-restoring biomaterials for wrinkle improvement. It is based on a rigorous design, including randomization, double-blinding (evaluator and subject), and an active control group. This case exemplifies a growing trend in the aesthetic medical device field to strengthen scientific evidence.
The clinical trials approved this month demonstrate active efforts across diverse fieldsโsuch as ultrasound, biomaterials, and digital technologyโto overcome the limitations of existing treatments. Notably, there is a growing trend to comprehensively assess not just simple technological performance, but also safety and clinical effectiveness in real-world usage environments.
We will continue to provide valuable insights related to clinical trials.
Thank you! ๐
๐ References
- Carruthers, A., Carruthers, J., Hardas, B., Kaur, M., Goertelmeyer, R., Jones, D., ... & Buchner, L. (2008). A validated grading scale for crow's feet. Dermatologic surgery, 34, S173-S178.
- Kane, M. A., Blitzer, A., Brandt, F. S., Glogau, R. G., Monheit, G. D., Narins, R. S., ... & Waugh, J. M. (2012). Development and validation of a new clinically-meaningful rating scale for measuring lateral canthal line severity. Aesthetic Surgery Journal, 32(3), 275-285.
Hello, JNPMEDI has prepared medical device clinical trial plans approved in June 2025.
Shall we take a closer look? ๐
In June 2025, the Ministry of Food and Drug Safety (MFDS) approved a total of 14 medical device clinical trials, including 5 for digital medical devices. This month saw approvals for a diverse range of indications, such as an ultrasound stimulation system aimed at opening the blood-brain barrier in dementia patients, digital technology-based biosignal analysis, and tissue-restoring biomaterials for facial wrinkle improvement.
Of particular note this month is the ultrasound stimulation clinical trial for opening the blood-brain barrier (BBB) in Alzheimer's dementia patients. This exploratory clinical trial involves injecting a contrast agent (Sonovue) followed by using a focused ultrasound stimulation system (NS-US200) to target the left dorsolateral prefrontal cortex. The study aims to evaluate the temporary opening of the BBB, along with the efficacy and safety of the procedure.
The blood-brain barrier acts as a biological shield that blocks external substances from entering the brain, historically serving as a major hurdle for neurological disease treatments. This trial evaluates an innovative ultrasound technology that non-invasively and temporarily opens this barrier, aiming to enhance drug delivery for brain disorders. Unlike existing methods like TMS or DBS, the key technical differentiator is its ability to stimulate the brain through the skull using ultrasound, allowing for repeated, non-invasive use without electrical stimulation.
Focused ultrasound stimulation systems primarily target central nervous system disorders like depression, dementia, and Parkinson's disease, with 101 related products already approved, indicating active research. However, this specific trial is considered a highly novel approach for dementia treatment. Its design phase demands multi-layered safety evaluations, including ultrasound output accuracy, penetration depth, and focal point precision, alongside biocompatibility of scalp contact materials and electromagnetic safety. The Mini-Mental State Examination (MMSE) is suggested as a potential tool for measuring efficacy.
The MFDS is also establishing safety and efficacy evaluation standards for ultrasound-mediated BBB opening devices through its guidelines. The results of this clinical trial are expected to serve as a crucial benchmark for future regulatory directions. Showing potential to overcome drug delivery limitations in various neurological diseases beyond just dementia, this endeavor is highly evaluated not only for its clinical significance but also for its technological and policy implications.
Beyond this, a meticulously designed clinical trial in the aesthetic medical device sector for improving fine lines around the eyes was also approved this month. This exploratory trial evaluates the efficacy and safety of tissue-restoring biomaterials for wrinkle improvement. It is based on a rigorous design, including randomization, double-blinding (evaluator and subject), and an active control group. This case exemplifies a growing trend in the aesthetic medical device field to strengthen scientific evidence.
The clinical trials approved this month demonstrate active efforts across diverse fieldsโsuch as ultrasound, biomaterials, and digital technologyโto overcome the limitations of existing treatments. Notably, there is a growing trend to comprehensively assess not just simple technological performance, but also safety and clinical effectiveness in real-world usage environments.
We will continue to provide valuable insights related to clinical trials.
Thank you! ๐
๐ References