Hello, JNPMEDI has prepared medical device clinical trial plans approved in Aug 2025.
Shall we take a closer look? ๐
In August 2025, the Ministry of Food and Drug Safety (MFDS) approved 14 medical device clinical trials, including four involving digital medical technologies. The submissions covered a broad range of innovations, such as a virtual realityโbased dizziness rehabilitation program, a continuous glucose monitoring system for pediatric diabetes, tissue-repair biomaterials, and a low-power light therapy device.
Clinical indications ranged across dizziness, diabetes, nasolabial fold improvement, osteoarthritis, and other conditions.
The most notable approval this month was NeuroEars-Theraโข, a VRยทAI-based vestibular rehabilitation digital therapeutic for patients with vestibular dysfunction and dizziness. Although vestibular rehabilitation exercises are well-established, patient adherence often remains low due to repetitive routines and difficulty ensuring correct execution.
NeuroEars-Theraโข addresses these challenges through real-time head and eye-tracking with personalized feedback, improving engagement and accuracy. The clinical trial will involve approximately 100 participants over up to 12 months to evaluate safety and efficacy.
Additional approvals this month include a tissue-repair biomaterial for nasolabial fold improvement, a continuous glucose monitoring device for pediatric diabetes, and a digital therapeutic for pediatric torticollis, reflecting continued diversification in medical device clinical development.
The August approvals highlight two emerging trends:
(1) the increasing sophistication of digital therapeutics, and
(2) the expansion of devices addressing chronic and lifestyle-related conditions.
Notably, several trials are designed not only to confirm device performance but also to demonstrate real-world clinical effectiveness, potentially accelerating future commercialization and regulatory review.
We will continue to share key updates and insights in clinical trial trends.
Thank you ๐
๐ References
https://news.mt.co.kr/mtview.php?no=2025081317285197597
https://neuroears.co.kr/bbs/content?co_id=ksub01_1&midx=13
Hello, JNPMEDI has prepared medical device clinical trial plans approved in Aug 2025.
Shall we take a closer look? ๐
In August 2025, the Ministry of Food and Drug Safety (MFDS) approved 14 medical device clinical trials, including four involving digital medical technologies. The submissions covered a broad range of innovations, such as a virtual realityโbased dizziness rehabilitation program, a continuous glucose monitoring system for pediatric diabetes, tissue-repair biomaterials, and a low-power light therapy device.
Clinical indications ranged across dizziness, diabetes, nasolabial fold improvement, osteoarthritis, and other conditions.
The most notable approval this month was NeuroEars-Theraโข, a VRยทAI-based vestibular rehabilitation digital therapeutic for patients with vestibular dysfunction and dizziness. Although vestibular rehabilitation exercises are well-established, patient adherence often remains low due to repetitive routines and difficulty ensuring correct execution.
NeuroEars-Theraโข addresses these challenges through real-time head and eye-tracking with personalized feedback, improving engagement and accuracy. The clinical trial will involve approximately 100 participants over up to 12 months to evaluate safety and efficacy.
Additional approvals this month include a tissue-repair biomaterial for nasolabial fold improvement, a continuous glucose monitoring device for pediatric diabetes, and a digital therapeutic for pediatric torticollis, reflecting continued diversification in medical device clinical development.
The August approvals highlight two emerging trends:
(1) the increasing sophistication of digital therapeutics, and
(2) the expansion of devices addressing chronic and lifestyle-related conditions.
Notably, several trials are designed not only to confirm device performance but also to demonstrate real-world clinical effectiveness, potentially accelerating future commercialization and regulatory review.
We will continue to share key updates and insights in clinical trial trends.
Thank you ๐
๐ References
https://news.mt.co.kr/mtview.php?no=2025081317285197597
https://neuroears.co.kr/bbs/content?co_id=ksub01_1&midx=13