Hello, JNPMEDI has prepared the status of the medical device clinical trial plans approved in August.
Shall we take a closer look? ๐
Approvalย Date | Title | Product | Trial Site |
2024-08-05 | A single-center, retrospective, confirmatory clinical trial to evaluate the clinical efficacy of a Class II ECG analysis software (ECG Buddy for Cardiologists), which assists physicians' diagnoses by providing risk scores related to heart disease through the analysis of ECG images or waveform data for screening purposes |
ECG Analysis Software (E01020.01)ย | Seoul National University Bundang Hospital |
2024-08-05 | Clinical validation of automatic analysis software for Perfusion-weighted MR imaging (PWI) and Diffusion-weighted MR imaging (DWI): A retrospective, multicenter, confirmatory clinical trial to evaluate the efficacy of JLK-PWI, which automatically analyzes perfusion-weighted MR images and diffusion-weighted MR images to provide quantitative analysis results of hypoperfused areas and ischemic cores.ย |
Brain Image Detection and Diagnostic Support Software. (E06090.01)ย |
Seoul National University Bundang Hospital, Chonam National University Hospitalย |
2024-08-05 | A multicenter, prospective, single-arm, open-label, exploratory clinical trial to evaluate the efficacy and safety of the non-invasive glucose monitor 'GlucoSOUND' for blood glucose measurement in prediabetic and diabetic patients.ย |
The Device for Gastrointestinal Function (A26000)ย |
The Catholic University of Korea Seoul St.Maryโs Hospital, University of Kangwon Hospitalย |
2024-08-19 | Evaluation of the efficacy and safety of the Focused Ultrasound Stimulation System (LIPOGE-X, ULTLINE/ESK-3269LX) for temporary improvement of skin elasticity in the thigh: A prospective, single-center, single-arm, confirmatory clinical trial | Focused Ultrasound Stimulation System (A35100.03) | Yonsei University Wonju Severance Christian Hospital |
2024-08-19 | A single-center, retrospective, confirmatory clinical trial to verify the clinical efficacy of software that predicts the presence of depression at the next visit (within 4 weeks ยฑ 1 week) based on patient information (gender, age) and historical time-series data obtained from the last consultation (outpatient or inpatient status, types/doses of prescribed medications, HAM-D scores)ย | Psychological Assessment Software (E06050.01) |
The Catholic University of Korea Seoul St.Maryโs Hospitalย |
2024-08-21 | A multicenter, prospective, randomized, double-blind, comparative, investigator-initiated exploratory clinical trial to evaluate the efficacy and safety of balloon dilation-laser treatment using a semiconductor laser device (EsoLight Z360) in patients with dependency on PPI formulations and gastroesophageal reflux disease, compared to a sham control device, in conjunction with esomeprazole treatmentย |
Semiconductor Laser Surgical Device (A37010.10)ย |
Asan Foundation Seoul Asan Hospital, Inha University College of Medicine Affiliated Hospitalย |
This month, there has been a notable increase in the approval of clinical trial plans for software-related medical devices. Many of these trials require extensive data collection and analysis, and using Digital Biomarkers makes this process significantly easier.
Digital Biomarkers refer to objective and quantitative physiological behavior data collected and measured through wearable and implantable or digestible digital tools, as the digitalization of the bio industry progresses.
It is an extended concept of biomarkers, which is an indicator or surrogate marker, used to objectively measure and evaluate drug responsiveness to normal biological processes, diseases, progress, and treatment methods.
For example, while blood pressure is a traditional biomarker, if it is collected through digital devices, it becomes a digital biomarker.
The digital biomarker market is continuously growing, driven by several key factors, including the real-time monitoring of critical medical data (e.g., vital signs and patient-specific parameters), an increasing need for patient monitoring, and chronic disease management. Additionally, advancements in technologies such as artificial intelligence, machine learning, and wearable devices, along with the rise of telemedicine, are further propelling market growth.
The global digital biomarker market is expected to grow from approximately $5.55 billion (about 7.57 trillion KRW) in 2024 to around $35.84 billion (about 48.89 trillion KRW) by 2035, with an average annual growth rate of about 18.5%.
JNPMEDI will be back soon next month with updates on medical device clinical trial plan approvals and useful information๐
โถ References
Medical Device Safety Book: https://emedi.mfds.go.kr/portal
Korea Bio Association, Korea Bio Economy Research Center. "Opportunities for Digital Biomarkers in New Drug Development" (Issue 162). September 2022.
Korea Health Industry Development Institute. "Global Health Industry Trends" (Vol. 511). 2024.
Hello, JNPMEDI has prepared the status of the medical device clinical trial plans approved in August.
Shall we take a closer look? ๐
This month, there has been a notable increase in the approval of clinical trial plans for software-related medical devices. Many of these trials require extensive data collection and analysis, and using Digital Biomarkers makes this process significantly easier.
Digital Biomarkers refer to objective and quantitative physiological behavior data collected and measured through wearable and implantable or digestible digital tools, as the digitalization of the bio industry progresses.
It is an extended concept of biomarkers, which is an indicator or surrogate marker, used to objectively measure and evaluate drug responsiveness to normal biological processes, diseases, progress, and treatment methods.
For example, while blood pressure is a traditional biomarker, if it is collected through digital devices, it becomes a digital biomarker.
The digital biomarker market is continuously growing, driven by several key factors, including the real-time monitoring of critical medical data (e.g., vital signs and patient-specific parameters), an increasing need for patient monitoring, and chronic disease management. Additionally, advancements in technologies such as artificial intelligence, machine learning, and wearable devices, along with the rise of telemedicine, are further propelling market growth.
The global digital biomarker market is expected to grow from approximately $5.55 billion (about 7.57 trillion KRW) in 2024 to around $35.84 billion (about 48.89 trillion KRW) by 2035, with an average annual growth rate of about 18.5%.
JNPMEDI will be back soon next month with updates on medical device clinical trial plan approvals and useful information๐
โถ References
Medical Device Safety Book: https://emedi.mfds.go.kr/portal
Korea Bio Association, Korea Bio Economy Research Center. "Opportunities for Digital Biomarkers in New Drug Development" (Issue 162). September 2022.
Korea Health Industry Development Institute. "Global Health Industry Trends" (Vol. 511). 2024.