According to the MFDS IND approval status, thirteen investigational medical devices received approval from the Ministry of Food and Drug Safety in January 2025. This month, various innovative technologies—such as neuromodulation devices, devices using near‑infrared spectroscopy (NIRS), smartphone‑based blood pressure analysis, transcranial photobiomodulation (tPBM), digital therapeutics (DTx), tissue‑restorative biomaterials and AI‑powered gastric‑cancer detection and diagnostic software—were approved, broadening the horizon of digital healthcare. Below we examine the major approvals and interpret the significance of these technologies.
1. Neuromodulation and Functional Testing
On 31 January, a third‑class otologic device combining vagus‑nerve stimulation and sound stimulation was approved for a pilot clinical trial to relieve subjective tinnitus. Vagus‑nerve stimulation delivers electrical impulses to the vagus nerve to influence brain activity; the vagus nerve controls digestion and heart rate. According to Mayo Clinic, vagus‑nerve stimulation is used to treat hard‑to‑control epilepsy and depression, and non‑invasive devices have been approved for cluster headaches and migraines. Research is exploring its potential in conditions such as rheumatoid arthritis, inflammatory bowel disease, bipolar disorder, obesity and Alzheimer’s disease. The current study evaluates whether pairing sound stimulation with vagus‑nerve stimulation can relieve tinnitus.
A transcutaneous electrical nerve stimulation (TENS) device was approved on 24 January to evaluate blood‑pressure‑lowering effects in early‑stage hypertension. While TENS is typically used for pain relief, the study explores its potential as a non‑pharmacological therapy for cardiovascular conditions.
2. NIRS‑Based Testing and Smartphone Blood‑Pressure Analysis
On the same day, the Alz sniff (N2) oximeter was approved. This device measures changes in oxygenated and deoxygenated hemoglobin in the brain following olfactory stimulation using near‑infrared spectroscopy (NIRS) to screen for beta‑amyloid positivity prior to PET‑CT. It is an innovative attempt to detect cognitive changes quickly.
The PulseFace software uses a smartphone camera to analyse facial videos in real time and estimate blood pressure. Video photoplethysmography (vPPG) is a contactless optical technique that records skin blood pulsations using a digital camera, enabling accurate measurement of physiological parameters. vPPG detects subtle colour changes caused by blood pulsations and can be performed with ambient light and a smartphone, making it accessible for remote monitoring. The current trial compares the software’s readings to a standard sphygmomanometer.
3. Transcranial Photobiomodulation (tPBM) – Lighting Up the Brain
On 16 January, three exploratory trials of transcranial photobiomodulation devices were approved for Parkinson’s disease, depression and stroke rehabilitation. Photobiomodulation (PBM) is a non‑invasive therapy that uses red or near‑infrared light (600–1100 nm) to stimulate cellular processes that promote tissue healing and regeneration. Clinical studies have shown that PBM increases cerebral oxygenation, improving cognition, alleviates depressive symptoms and enhances cognitive or motor function in neurodegenerative disorders such as dementia and Parkinson’s disease. These trials apply tPBM to Korean patients with neurological and psychiatric disorders.
4. Digital Therapeutics and Clinical Software
The re‑R musculoskeletal rehabilitation software trial compares rehabilitation software with home exercises in patients undergoing total knee arthroplasty. WMA‑01, a hospital care software, will evaluate allergy‑reaction improvement in children with food allergies relative to standard care.
On 7 January, the ANZEILAX digital therapeutic began a trial for unspecified anxiety disorder, and another digital therapeutic for alcohol‑use disorder received confirmatory trial approval. The Digital Therapeutics Alliance defines DTx as evidence‑based therapeutic interventions driven by high‑quality software to treat, manage or prevent a disease or disorder. Korea’s MFDS similarly defines DTx as software as a medical device providing evidence‑based therapeutic interventions for prevention, control or treatment. Unlike pharmaceuticals, DTx have lower development costs and enable real‑time data collection. The new approvals broaden digital therapeutics to mental‑health indications.
5. Tissue‑Restorative Biomaterials – Hyaluronic‑Acid Fillers
On 13 January, a trial of Obsessfill Shape and Rejuran HB plus—hyaluronic‑acid‑based tissue restorative biomaterials—was approved to assess wrinkle improvement in crow’s feet. Cross‑linked hyaluronic acid (HA) dermal fillers are widely used for minimally invasive facial aesthetics. A recent study noted that cross‑linked HA fillers safely enhance lips, cheeks and nasolabial folds with significant wrinkle reduction and no safety concerns. HA fillers restore volume, improve facial contours and offer a non‑surgical solution for cheek augmentation and wrinkle reduction. The current trial evaluates the safety and efficacy of domestic products.
6. AI‑Based Gastric‑Cancer Detection Software
On 2 January, an AI‑assisted software for detecting gastric cancer, adenomas and intestinal metaplasia in endoscopic images received confirmatory trial approval. Artificial intelligence has improved the extraction of abnormal information from endoscopic images, increasing the detection rate of early gastric cancer and enhancing patient survival. Deep learning and convolutional neural networks can distinguish cancer types, invasion depth and lesion boundaries. AI serves as a clinical aid rather than replacing physicians, and high‑quality data and further research are still needed. The new software, built on Korean endoscopic data, may set a new standard for early gastric‑cancer diagnosis.
Conclusion and Outlook
January 2025’s MFDS IND approvals highlight innovations across neuromodulation, light therapy, smartphone‑based analysis, digital therapeutics, biomaterials and AI‑assisted diagnostics. Vagus‑nerve stimulation and TENS offer new non‑pharmacological options for neurological and cardiovascular disorders, while NIRS and vPPG technologies enable non‑contact monitoring. tPBM trials extend light‑based neuromodulation to Parkinson’s disease, depression and stroke. Digital therapeutics expand to anxiety and alcohol‑use disorders, and hyaluronic‑acid filler research strengthens domestic biomaterials. Finally, AI‑based gastric‑cancer software promises to improve early diagnosis and patient outcomes.
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