Digital therapeutics (DTx) are emerging as a transformative innovation in healthcare offering evidence-based digital interventions for the treatment, management, and prevention of various diseases and disorders. In Korea, DTx have gained significant attention as potential solutions to the increasing burden of chronic diseases and mental health conditions. However, the Korean DTx market faces several challenges that hinder its widespread adoption and integration into the national healthcare system. This study provides a comprehensive analysis of the current state of the DTx market in Korea, identifies the key challenges impeding its growth, and proposes strategies for overcoming these obstacles. This study utilized a literature review and market analysis approach to examine the latest research, industry reports, and regulatory documents related to DTx. The analysis focused on three primary areas: (1) the current regulatory landscape, (2) technological advancements and challenges, and (3) economic and commercial factors influencing DTx adoption in Korea. A comparative analysis of global regulatory practices was also conducted to identify best practices. The findings revealed that while Korea has made significant strides in supporting DTx development, the market remains in its early stages. The key challenges include underdeveloped regulatory frameworks, issues with data quality and security, and a lack of established reimbursement pathways. We recommend developing tailored regulatory frameworks for DTx, enhancing policy support for small and medium-sized enterprises involved in DTx development, and increasing investments in technological infrastructure. By addressing these challenges, Korea could position itself as a leader in the global DTx market, delivering innovative and effective treatments to enhance patient care and outcomes.

Digital therapeutics (DTx) are emerging as a transformative innovation in healthcare offering evidence-based digital interventions for the treatment, management, and prevention of various diseases and disorders. In Korea, DTx have gained significant attention as potential solutions to the increasing burden of chronic diseases and mental health conditions. However, the Korean DTx market faces several challenges that hinder its widespread adoption and integration into the national healthcare system. This study provides a comprehensive analysis of the current state of the DTx market in Korea, identifies the key challenges impeding its growth, and proposes strategies for overcoming these obstacles. This study utilized a literature review and market analysis approach to examine the latest research, industry reports, and regulatory documents related to DTx. The analysis focused on three primary areas: (1) the current regulatory landscape, (2) technological advancements and challenges, and (3) economic and commercial factors influencing DTx adoption in Korea. A comparative analysis of global regulatory practices was also conducted to identify best practices. The findings revealed that while Korea has made significant strides in supporting DTx development, the market remains in its early stages. The key challenges include underdeveloped regulatory frameworks, issues with data quality and security, and a lack of established reimbursement pathways. We recommend developing tailored regulatory frameworks for DTx, enhancing policy support for small and medium-sized enterprises involved in DTx development, and increasing investments in technological infrastructure. By addressing these challenges, Korea could position itself as a leader in the global DTx market, delivering innovative and effective treatments to enhance patient care and outcomes.

Digital therapeutics (DTx) are emerging as a transformative innovation in healthcare offering evidence-based digital interventions for the treatment, management, and prevention of various diseases and disorders. In Korea, DTx have gained significant attention as potential solutions to the increasing burden of chronic diseases and mental health conditions. However, the Korean DTx market faces several challenges that hinder its widespread adoption and integration into the national healthcare system. This study provides a comprehensive analysis of the current state of the DTx market in Korea, identifies the key challenges impeding its growth, and proposes strategies for overcoming these obstacles. This study utilized a literature review and market analysis approach to examine the latest research, industry reports, and regulatory documents related to DTx. The analysis focused on three primary areas: (1) the current regulatory landscape, (2) technological advancements and challenges, and (3) economic and commercial factors influencing DTx adoption in Korea. A comparative analysis of global regulatory practices was also conducted to identify best practices. The findings revealed that while Korea has made significant strides in supporting DTx development, the market remains in its early stages. The key challenges include underdeveloped regulatory frameworks, issues with data quality and security, and a lack of established reimbursement pathways. We recommend developing tailored regulatory frameworks for DTx, enhancing policy support for small and medium-sized enterprises involved in DTx development, and increasing investments in technological infrastructure. By addressing these challenges, Korea could position itself as a leader in the global DTx market, delivering innovative and effective treatments to enhance patient care and outcomes.

Digital therapeutics (DTx) are emerging as a transformative innovation in healthcare offering evidence-based digital interventions for the treatment, management, and prevention of various diseases and disorders. In Korea, DTx have gained significant attention as potential solutions to the increasing burden of chronic diseases and mental health conditions. However, the Korean DTx market faces several challenges that hinder its widespread adoption and integration into the national healthcare system. This study provides a comprehensive analysis of the current state of the DTx market in Korea, identifies the key challenges impeding its growth, and proposes strategies for overcoming these obstacles. This study utilized a literature review and market analysis approach to examine the latest research, industry reports, and regulatory documents related to DTx. The analysis focused on three primary areas: (1) the current regulatory landscape, (2) technological advancements and challenges, and (3) economic and commercial factors influencing DTx adoption in Korea. A comparative analysis of global regulatory practices was also conducted to identify best practices. The findings revealed that while Korea has made significant strides in supporting DTx development, the market remains in its early stages. The key challenges include underdeveloped regulatory frameworks, issues with data quality and security, and a lack of established reimbursement pathways. We recommend developing tailored regulatory frameworks for DTx, enhancing policy support for small and medium-sized enterprises involved in DTx development, and increasing investments in technological infrastructure. By addressing these challenges, Korea could position itself as a leader in the global DTx market, delivering innovative and effective treatments to enhance patient care and outcomes.

Background: Ensuring reference material (RM) commutability is crucial for evaluating measurement traceability in order to standardize laboratory tests. However, commutability assessment is not routinely performed. We assessed whether RMs prepared following CLSI C37-A guidelines could be used without assessing commutability by evaluating their commutability for four lipid measurements using the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and CLSI EP14 protocols. Methods: We analyzed total cholesterol (TC), triglycerides (TGs), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) in frozen sera from 20 individuals and 11 RMs, prepared by the Korea Disease Control and Prevention AgencyLaboratory Standardization Project (per CLSI C37-A), using six routine measurement procedures (MPs). Regression equations and 95% prediction intervals derived from single-donor sera were analyzed following CLSI EP14. The IFCC protocol was used to assess differences in inter-MP biases between RM and clinical samples. The effect of the TG concentration on commutability was evaluated by analyzing biases between MP results and reference procedure-assigned values. Results: RMs were commutable for most MP pairs for TC and TG. Commutability for HDL-C and LDL-C varied across RMs, with RM10 and RM11 showing higher TG levels (2.38 and 2.95 mmol/L, respectively) and lower commutability. Increased bias percentages from assigned values were observed for RMs with higher TG levels. Conclusions RMs prepared per CLSI C37-A were commutable with most MP pairs for TC and TG. Elevated TG levels affected HDL-C and LDL-C commutability, highlighting the need to consider TG concentrations during RM preparation and assess commutability to standardize laboratory tests.

Purpose: This study aimed to determine whether micro-flow imaging (MFI) offers diagnostic performance comparable to that of contrast-enhanced ultrasonography (CEUS) in detecting segmental congestion among patients undergoing living donor liver transplantation (LDLT). Methods: Data from 63 patients who underwent LDLT between May and December 2022 were retrospectively analyzed. MFI and CEUS data collected on the first postoperative day were quantified. Segmental congestion was assessed based on imaging findings and laboratory data, including liver enzymes and total bilirubin levels. The reference standard was a postoperative contrast-enhanced computed tomography scan performed within 2 weeks of surgery. Additionally, a subgroup analysis examined patients who underwent reconstruction of the middle hepatic vein territory. Results: The sensitivity and specificity of MFI were 73.9% and 67.5%, respectively. In comparison, CEUS demonstrated a sensitivity of 78.3% and a specificity of 75.0%. These findings suggest comparable diagnostic performance, with no significant differences in sensitivity (P=0.655) or specificity (P=0.257) between the two modalities. Additionally, early postoperative laboratory values did not show significant differences between patients with and without congestion. The subgroup analysis also indicated similar diagnostic performance between MFI and CEUS. Conclusion MFI without contrast enhancement yielded results comparable to those of CEUS in detecting segmental congestion after LDLT. Therefore, MFI may be considered a viable alternative to CEUS.

Purpose: This report offers a detailed examination of the inception and current state of the Heavy-ion Therapy Center (HITC) at the Yonsei Cancer Center (YCC), setting it apart as the world’s first center equipped with a fixed beam and two superconducting gantries for carbon-ion radiation therapy (CIRT). Materials and Methods: Preparations for CIRT at YCC began in 2013; accordingly, this center has completed a decade of meticulous planning and culminating since the operational commencement of the HITC in April 2023. Results: This report elaborates on the clinical preparation for adopting CIRT in Korea. It includes an extensive description of HITC’s facility layout at YCC, which comprises the accelerator and treatment rooms. Furthermore, this report delineates the clinical workflow, criteria for CIRT application, and the rigorous quality assurance processes implemented at YCC. It highlights YCC’s sophisticated radiation therapy infrastructure, collaborative initiatives, and the efficacious treatment of >200 prostate cancer cases utilizing CIRT. Conclusion This manuscript concludes by discussing the prospective influence of CIRT on the medical domain within Korea, spotlighting YCC’s pioneering contribution and forecasting the widespread integration of this groundbreaking technology.

Purpose: This report offers a detailed examination of the inception and current state of the Heavy-ion Therapy Center (HITC) at the Yonsei Cancer Center (YCC), setting it apart as the world’s first center equipped with a fixed beam and two superconducting gantries for carbon-ion radiation therapy (CIRT). Materials and Methods: Preparations for CIRT at YCC began in 2013; accordingly, this center has completed a decade of meticulous planning and culminating since the operational commencement of the HITC in April 2023. Results: This report elaborates on the clinical preparation for adopting CIRT in Korea. It includes an extensive description of HITC’s facility layout at YCC, which comprises the accelerator and treatment rooms. Furthermore, this report delineates the clinical workflow, criteria for CIRT application, and the rigorous quality assurance processes implemented at YCC. It highlights YCC’s sophisticated radiation therapy infrastructure, collaborative initiatives, and the efficacious treatment of >200 prostate cancer cases utilizing CIRT. Conclusion This manuscript concludes by discussing the prospective influence of CIRT on the medical domain within Korea, spotlighting YCC’s pioneering contribution and forecasting the widespread integration of this groundbreaking technology.

Purpose: This report offers a detailed examination of the inception and current state of the Heavy-ion Therapy Center (HITC) at the Yonsei Cancer Center (YCC), setting it apart as the world’s first center equipped with a fixed beam and two superconducting gantries for carbon-ion radiation therapy (CIRT). Materials and Methods: Preparations for CIRT at YCC began in 2013; accordingly, this center has completed a decade of meticulous planning and culminating since the operational commencement of the HITC in April 2023. Results: This report elaborates on the clinical preparation for adopting CIRT in Korea. It includes an extensive description of HITC’s facility layout at YCC, which comprises the accelerator and treatment rooms. Furthermore, this report delineates the clinical workflow, criteria for CIRT application, and the rigorous quality assurance processes implemented at YCC. It highlights YCC’s sophisticated radiation therapy infrastructure, collaborative initiatives, and the efficacious treatment of >200 prostate cancer cases utilizing CIRT. Conclusion This manuscript concludes by discussing the prospective influence of CIRT on the medical domain within Korea, spotlighting YCC’s pioneering contribution and forecasting the widespread integration of this groundbreaking technology.

Purpose: This study aimed to determine whether micro-flow imaging (MFI) offers diagnostic performance comparable to that of contrast-enhanced ultrasonography (CEUS) in detecting segmental congestion among patients undergoing living donor liver transplantation (LDLT). Methods: Data from 63 patients who underwent LDLT between May and December 2022 were retrospectively analyzed. MFI and CEUS data collected on the first postoperative day were quantified. Segmental congestion was assessed based on imaging findings and laboratory data, including liver enzymes and total bilirubin levels. The reference standard was a postoperative contrast-enhanced computed tomography scan performed within 2 weeks of surgery. Additionally, a subgroup analysis examined patients who underwent reconstruction of the middle hepatic vein territory. Results: The sensitivity and specificity of MFI were 73.9% and 67.5%, respectively. In comparison, CEUS demonstrated a sensitivity of 78.3% and a specificity of 75.0%. These findings suggest comparable diagnostic performance, with no significant differences in sensitivity (P=0.655) or specificity (P=0.257) between the two modalities. Additionally, early postoperative laboratory values did not show significant differences between patients with and without congestion. The subgroup analysis also indicated similar diagnostic performance between MFI and CEUS. Conclusion MFI without contrast enhancement yielded results comparable to those of CEUS in detecting segmental congestion after LDLT. Therefore, MFI may be considered a viable alternative to CEUS.