This report informs pharmaceutical and biotech professionals about MFDS approvals of clinical‑trial medical devices in September 2025. Seven approvals show how the landscape is shifting: digital therapeutic software, AI‑assisted image analysis, 3D‑printed ankle implants, automated insulin‑delivery software, an electronic thermometer, a hyaluronic‑acid dermal filler and a transcranial direct‑current stimulation (tDCS) device. These approvals illustrate the growth of digital health and patient‑specific technologies and bolster Korea’s competitiveness.
Digital therapeutics and AI software
The first approval is rehabilitation software that predicts the success of spontaneous breathing trials in intubated ICU patients. By analysing clinical information and ventilator settings, it guides decisions on when to attempt extubation. Digital therapeutics deliver evidence‑based interventions via software and often rely on behavioural changes. The second approval is AI‑assisted software that detects abnormal lesions on colonoscopy images and provides probability information. Computer‑aided detection systems highlight suspicious areas in digital images to support diagnosis. Both programmes underwent confirmatory clinical trials.
Medical device: 3D‑printed ankle implant
The third approval concerns a patient‑specific, 3D‑printed talar implant for revision ankle replacement surgery. Three‑dimensional printing allows customised implants and surgical instruments, improving planning and outcomes. Total talus replacement with 3D‑printed implants is considered a viable alternative to fusion or standard total ankle arthroplasty; patient‑specific devices ensure precise alignment and may reduce operative time and blood loss.
Automated insulin delivery and vital‑sign monitoring
The fourth approval is ‘CloudLoop’, automated software that monitors glucose and adjusts insulin delivery for adults with type 2 diabetes using multiple daily or premixed injections. Closed‑loop insulin systems link continuous glucose monitors with pumps to automatically deliver insulin; they are often called artificial pancreases and aim to improve glycaemic control. The fifth approval evaluates the accuracy and safety of the XST600 electronic thermometer compared with the 3M SpotOn device. Digital thermometers display temperature numerically and usually have a resolution of 0.1 °C; new ear thermometers often have ±0.2 °C accuracy.
Filler clinical trial and tDCS
The sixth item is a multi‑centre trial of the hyaluronic‑acid filler ‘DIOSHA S Lido’, comparing its efficacy and safety to YOUTHFILL Fine with Lidocaine for nasolabial folds. Hyaluronic‑acid fillers restore volume and smooth wrinkles. Nasolabial folds deepen with age and dermal fillers replace lost fat and collagen. The seventh approval is an exploratory trial of a tDCS device for gait improvement in patients with mild to moderate idiopathic Parkinson’s disease. tDCS involves delivering a weak direct current via scalp electrodes; it was developed for patients with brain injuries or neuropsychiatric conditions. Evidence for its efficacy in Parkinson’s disease is limited, so this trial explores its potential.
These approvals, spanning digital therapeutics, AI, 3D printing, diabetes management, vital‑sign monitoring, aesthetic medicine and neuromodulation, indicate that Korea’s medical‑device industry is embracing cutting‑edge technologies and meeting global standards.
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