February 2025 MFDS IND Approval Status shows that thirteen investigational medical devices received clearance from South Korea’s Ministry of Food and Drug Safety. Under Korea’s Digital Medical Products Act, devices that require clinical trial data or incorporate software/AI must follow the MFDS IND process. Since the agency issued guidelines for generative‑AI medical devices on 24 January 2025, companies have rapidly developed digital therapeutics for conditions ranging from ADHD and postpartum depression to autism spectrum disorder and post‑stroke aphasia.
Digital therapeutics for children and adolescents
The February list includes several digital tools for pediatric neurodevelopmental disorders. AttnKare‑D is a cognitive assessment program being tested as a diagnostic aid for children with attention‑deficit/hyperactivity disorder (ADHD). EYAS‑Focus evaluates whether an ADHD digital therapy can improve attention and concentration in a single‑centre, randomized, open‑label study. Tokyland_DTx compares an ASD digital therapy against standard language therapy in children aged 7 to 12, assessing improvements in language disorders.
Digital therapeutics deliver evidence‑based interventions via software and rely on behavioral or lifestyle changes. Non‑pharmacologic options are especially attractive for pediatric patients with limited tolerance or response to drugs, and gamified tasks with real‑time feedback can improve adherence.
Women’s mental health and mood disorder software
Two approvals involve mood disorder software. The first study targets pregnant women or those within four weeks postpartum who exhibit depressive symptoms; it assesses whether a software‑based intervention incorporating psychoeducation and mood monitoring improves mood. The second trial evaluates the safety and efficacy of a digital therapeutic for acute panic symptoms in patients with panic disorder using a multi‑centre, randomized, single‑blind design.
Mood disorders often require combined pharmacologic and non‑pharmacologic approaches; digital therapeutics can offer emotion regulation training, cognitive‑behavioural modules and real‑time self‑report tools. For treatment‑resistant depression, the U.S. FDA has approved vagus nerve stimulation, which sends electrical impulses to the vagus nerve to alter brain activity and treat seizures and mood disorders. Non‑invasive vagus nerve stimulation is also being explored as an alternative for depression and anxiety.
Rehabilitation of language and cognition
ZeniCom is a digital therapy for improving aphasia (AQ ≥ 25) in the subacute phase after stroke; the multi‑centre, single‑blind randomized exploratory trial will evaluate its safety and efficacy. Home‑based digital rehabilitation allows repetitive practice and AI‑driven speech recognition can correct errors, potentially enhancing outcomes. In a study of mild cognitive impairment caused by Alzheimer’s disease, a brain electrical stimulation device uses transcranial alternating current stimulation (tACS) to test whether temporary memory improvement can be achieved.
tACS applies weak currents through electrodes on the scalp to modulate brain rhythms and improve cognition. According to the Mayo Clinic, vagus nerve stimulation sends electrical impulses to the vagus nerve, which controls digestion, heart rate and other vital functions, and changes brain activity to treat seizures and mood disorders. The clinic notes that non‑surgical vagus‑stimulation devices approved in the U.S. treat cluster headaches and migraine by applying the device to the neck to block pain signals, and researchers are exploring the therapy for conditions such as rheumatoid arthritis, inflammatory bowel disease, bipolar disorder, obesity and Alzheimer’s disease. Combining neuromodulation with digital therapies may herald a new era of brain rehabilitation.
AI image and physiological analysis and ultrasound stimulation
Artificial‑intelligence tools also feature prominently. SkinEX_Burn is a wound‑image analysis program that evaluates burn depth from photographs in a retrospective, evaluator‑blinded trial. By analyzing color, texture and boundaries, deep burns can be distinguished from superficial burns, enabling triage and prognostic assessment. HypoWave uses intensive‑care unit vital‑sign data to predict hypotension one hour in advance; its single‑centre, randomized, single‑blind, retrospective superiority study will test the model’s accuracy. Early prediction allows clinicians to adjust fluids and medications proactively, improving patient safety.
The CKD‑981 ultrasound stimulator trial tests whether ultrasound reduces pain and inflammation and temporarily improves function in degenerative knee osteoarthritis. Ultrasound therapy can increase blood flow and reduce swelling; the device is compared against a sham control in an exploratory study. Two physical‑therapy devices use transcutaneous vagus‑nerve stimulation in panic disorder and opioid‑withdrawal patients. They deliver electrical impulses to the vagus nerve, which controls digestion and heart rate, to alter brain activityand treat seizures or mood disorders. Non‑invasive devices placed on the neck have been approved for cluster headaches and migraine, and the technology’s potential applications continue to expand.
Organ‑function testing and long‑term monitoring
The MEDiLight organ‑function tester measures bladder volume in patients with neurogenic bladder. A single‑group, multi‑centre prospective study will compare its measurements to the volume of injected saline. The device uses optical sensors and ultrasound to estimate bladder volume non‑invasively, helping patients determine when to void and preventing urinary tract infections and kidney damage. Future research may integrate wearable sensors and mobile apps for real‑time monitoring and physician alerts.
Summary and outlook
The February 2025 MFDS IND approvals reveal a surge in digital therapeutics for mental health and neurodevelopmental disorders, AI‑based tools for burn assessment and hypotension prediction, non‑invasive neuromodulation devices, brain electrical stimulation, and organ‑function testing. Digital therapeutics deliver non‑pharmacologic interventions based on behavioural change and lifestyle modification, providing personalised solutions for children, women and the elderly. AI software supports clinicians by quantifying burn depth and predicting hypotension, enhancing efficiency and objectivity. Vagus‑nerve stimulation and tACS expand treatment options for mood and cognitive disorders; vagus nerve stimulation sends electrical impulses to the nerve controlling digestion and heart rate and is known to treat seizures and depression, with FDA approvals for post‑stroke rehabilitation and migraine and ongoing research in other diseases.
By aligning its regulatory framework with the U.S. FDA and European EMA, MFDS shortens review timelines and provides clear guidance for AI and digital medical devices. February’s approvals show Korea’s leadership in digital therapeutics and AI medical devices, offering collaboration opportunities for domestic and international pharmaceutical and biotech companies. Successful completion of these trials could accelerate the commercialization of personalized treatment and remote monitoring technologies worldwide.
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