March 2025 MFDS IND Approvals show that ten investigational medical devices received clearance from South Korea’s Ministry of Food and Drug Safety. Under MFDS regulations and the Digital Medical Products Act, which took effect in January 2025, devices that require clinical trial data or involve software/AI must secure MFDS approval. On 24 January 2025 the agency issued guidelines for the approval of generative AI software, aligning Korea with regulators like the U.S. FDA and the UK MHRA.
The March list therefore features several digital therapeutics and AI‑driven analysis tools. This article summarises the MFDS dataset so that domestic and international pharmaceutical and biotech professionals can better understand technology trends.
Digital therapeutics and mental health
Among the approved devices, ACT‑DTx for mood disorders, OCD OFF for obsessive‑compulsive disorder and a digital therapeutic for ADHD stand out. ACT‑DTx is a single‑centre, randomised superiority trial comparing the software against a sham control in patients with major depressive disorder. OCD OFF is a multi‑centre, randomised, open‑label trial evaluating safety and efficacy in individuals with obsessive‑compulsive disorder, while the ADHD device is a prospective, multi‑centre superiority study assessing attention improvement in children.
Digital therapeutics deliver evidence‑based interventions via software and rely on behavioural or lifestyle changes; they are attracting interest as non‑pharmacologic options for depression, OCD and ADHD because they can minimise drug‑related side effects and enhance patient engagement.
Cardiovascular AI software
The list includes SmartECG‑EF, an electrocardiogram analysis program that uses 12‑lead ECG data to score the likelihood of left‑ventricular systolic dysfunction and assist clinical decision‑making. Its multicentre retrospective pivotal study will measure how well the AI tool improves physicians’ diagnoses. USfeat.ai is an ultrasound‑imaging detection and diagnostic‑support program that calculates the probability of left‑ventricular hypertrophy caused by hypertensive heart disease, hypertrophic cardiomyopathy or cardiac amyloidosis.
A single‑centre retrospective trial will evaluate its diagnostic accuracy. The MFDS guidance issued in January 2025 clarifies approval processes for AI medical devices, including those built on large language or multimodal models, and requires explicit instructions and off‑label warnings, allowing developers to focus on clinical trial design and quality control.
Continuous glucose monitoring and sleep‑apnoea detection
The CareSens Air 2 continuous glucose monitoring (CGM) system also appears on the March list. CGM devices measure glucose every few minutes via a sensor placed under the skin and transmit the data wirelessly to a smartphone, pump or receiver; they provide real‑time glucose trends that help users adjust meals, exercise and medications and reduce hypoglycaemia.
The approved study will evaluate the safety and accuracy of CareSens Air 2 in adults with type 1 or type 2 diabetes. The Wellune‑M1 sleep‑apnoea monitor uses FMCW radar to collect breathing signals and screen for moderate or more severe sleep apnoea. A retrospective single‑centre trial will assess whether the device accurately identifies apnoea events. Such remote‑monitoring devices are in high demand because they minimise patient discomfort while continuously observing daily patterns.
Non‑invasive vagus‑nerve stimulation and high‑intensity focused ultrasound
Two physical‑therapy devices were approved in March. The first is a prospective, randomised exploratory study combining standard therapy with transcutaneous auricular vagus‑nerve electrical stimulation to improve depressive symptoms in patients with major depressive disorder. The second is an investigator‑initiated study using transcutaneous vagus‑nerve stimulation during tilt‑table therapy to improve consciousness levels in stroke patients with impaired awareness.
The vagus nerve connects the brain to multiple organs, and non‑invasive stimulation has shown promise in depression, insomnia and pain control. Finally, the high‑intensity focused ultrasound (HIFU) surgical device trial will compare combined FOLFIRINOX chemotherapy and HIFU treatment against chemotherapy alone in patients with locally advanced or borderline‑resectable pancreatic cancer. HIFU concentrates acoustic energy to destroy targeted tissues and can enhance drug delivery, potentially overcoming limitations of conventional surgery.
Summary and outlook
The March 2025 MFDS IND approvals reveal that diverse technologies—from digital therapeutics and AI‑driven diagnostics to continuous glucose monitoring, non‑invasive vagus‑nerve stimulation and focused ultrasound—are entering clinical development. Digital therapeutics, which deliver behavioural interventions via software, are rapidly being developed for depression, OCD and ADHD, while AI tools promise to support cardiovascular diagnoses and improve efficiency.
Continuous glucose monitoring and apnoea‑detection devices provide real‑time insights that can improve patient outcomes. If these devices successfully complete clinical trials, they are likely to be commercialised quickly in domestic and global markets. MFDS’s strengthened regulatory guidelines help balance innovation with patient safety and will play a pivotal role in shaping future medical technologies.
