The April 2025 MFDS clinical‑trial approval list spans 17 diverse applications, ranging from digital therapeutics and risk‑prediction software to transcutaneous vagus‑nerve stimulation devices. The approvals reflect the impact of the Digital Medical Device Act, which came into force in January 2025 and classifies software and AI‑based devices as regulated medical devices.
Digital therapeutics and decision‑support software
A variety of cognitive‑therapy and rehabilitation programs were authorized. These include digital‑therapy tools to improve communication in children with autism spectrum disorder, an exercise‑based program to enhance cognitive function in patients with mild cognitive impairment, and a hearing‑rehabilitation program for presbycusis. Diagnostic‑support software such as ALZGUARD assists dementia diagnosis according to DSM‑5 criteria, while LUCET targets reduction of problem behaviours in children. Digital therapeutics fit the definition of evidence‑based software used to prevent, manage or treat disease, and most studies employ prospective or randomised designs to verify safety and efficacy.
Predictive analytics software also stands out. A cardiovascular‑risk evaluation program quantifies the likelihood of atherosclerotic cardiovascular disease in hypertensive adults, and DeepFore estimates hepatocellular carcinoma risk in patients with chronic hepatitis B by analysing historical data. Vita Embryo, an obstetric/gynecologic program, ranks embryos to support clinicians in in vitro fertilisation procedures. An MRI‑based AI software for detecting acute stroke lesions operates in a similar vein to JLK‑CTP, which quantifies ischemic cores on CT perfusion images; both illustrate how AI‑assisted imaging software supports clinical decision‑making.
Diagnostic and therapeutic devices : non‑invasive stimulation and precision medicine
Beyond software, several devices were approved. Transcutaneous auricular vagus nerve stimulation (taVNS) is being studied as an adjunct therapy for drug‑resistant epilepsy in a cross‑over, double‑blind randomised trial. Physical‑therapy instruments NUEYNE V02/V03 aim to rehabilitate visual‑field defects after stroke, while Neuclare targets gait improvement in idiopathic normal pressure hydrocephalus. A continuous glucose monitoring system monitors venous thrombosis in patients after free‑flap breast reconstruction, demonstrating how real‑time glucose data support treatment decisions.
The TS‑RF universal electrosurgical system compares transseptal puncture using an electrosurgical generator and needle versus the traditional BRK needle in a non‑inferiority trial to assess safety and efficiency. Studies using the PST_EDOF‑1 anterior‑segment imaging device to observe conjunctival goblet‑cell density and the HOS‑BAND wearable thermometer to evaluate accuracy of oxygen saturation, pulse and temperature measurements demonstrate the importance of validating diagnostic equipment.
Biomaterials and tissue restoration : the intersection of aesthetics and regenerative medicine
An exploratory randomised study of the DMSB01 tissue‑restoration material aims to improve crow’s‑feet wrinkles. Hyaluronic acid and collagen provide moisture and elasticity to the skin, and injectable fillers replenish these constituents to restore volume and reduce wrinkles. By verifying the safety and non‑inferiority of filler products, MFDS is strengthening quality management in aesthetic and regenerative medicine.
Digital‑health trends and industrial significance
The April approvals show that digital therapeutics, risk‑prediction algorithms, non‑invasive neuromodulation and precision diagnostic devices are becoming core to medical‑device development. MFDS’s broader approvals—including hyperbaric oxygen chambers, continuous glucose monitors, digital therapeutics, VR‑based rehabilitation programmes and neural stimulators—highlight that digital health is at the centre of the medical‑device market. Because digital therapeutics rely on changes in behaviour and lifestyle and are being developed for diseases ranging from diabetes and heart failure to obesity and Alzheimer’s disease, the April list’s inclusion of epilepsy, presbycusis, autism spectrum disorder and infertility underscores the expanding range of indications.
Research on non‑pharmaceutical therapies such as non‑invasive neuromodulation, phototherapy and hyperbaric oxygen therapy is expanding, while big‑data‑driven risk‑prediction software and AI imaging analysis have become central tools in clinical decision‑making. Through the April approvals, MFDS will test 17 medical devices and software systems—digital therapeutics, risk‑prediction algorithms, imaging analysis programmes, continuous glucose monitors, vagus‑nerve stimulators, electrosurgical devices and anterior‑segment imaging systems—under clinical‑trial conditions. With multiple indications and technology platforms coexisting, companies must pay attention to data security, privacy protection and compliant study designs. The trend highlights to domestic and international pharmaceutical and biotech professionals that understanding regulatory changes and evolving clinical‑trial designs is essential.
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