Analysis of MFDS approvals in May 2025 shows that software‑based digital therapeutics and neuromodulation technologies are becoming core elements of medical‑device development. Twelve clinical‑trial plans were approved during the month. This pattern underscores the agency’s decision to treat software and AI‑based devices as regulated medical devices under the Digital Medical Device Act that took effect in January 2025, signaling the growing footprint of digital health.
Digital therapeutics and software – growth of multicenter randomized trials
Digital therapeutics deliver scientifically validated interventions via software to prevent, manage or treat disease. May’s approval list includes a cognitive‑therapy program for adults with ADHD, a multicenter superiority trial of NDTx‑01 for improving social cognition and interaction in children and adolescents with autism spectrum or social communication disorders, the The R MSK™ rehabilitation program for post‑surgical pain and recovery, RunForHeart software for cardiopulmonary rehabilitation, and SAVE‑U‑M biosignal analysis software that predicts in‑hospital mortality in trauma cases. These programs employ prospective or retrospective multicenter randomised designs to ensure objective evidence.
JLK‑CTP automatically analyzes CT perfusion images to quantify ischemic cores and hypoperfused areas, helping clinicians interpret stroke images. Its concept parallels AI‑based software that scans chest X‑rays, highlights suspect lesions and drafts preliminary reports. MFDS requires retrospective multicenter confirmatory studies for such software, emphasizing the need to prove safety and effectiveness.
Biomaterials and fillers – expansion of the tissue‑restoration market
Two biomaterial products were approved. A head‑to‑head trial comparing JTM102 and Juvederm VOLUMA with lidocaine evaluates the efficacy and safety of restoring volume in the mid‑face using a multicenter randomised design. A single‑arm investigator‑initiated trial of RenéFil Ultra Plus No.3 assesses initial safety. Hyaluronic acid and collagen are crucial for skin elasticity, and injectable fillers restore volume and smooth wrinkles. By permitting non‑inferiority and safety comparisons of fillers, MFDS is widening the tissue‑restoration market alongside advanced regenerative technologies such as 3D‑printed bespoke implants.
Neuromodulation and physical‑stimulus devices – innovations targeting dementia and Parkinson’s disease
High‑intensity focused ultrasound (HIFU) opens the blood–brain barrier to enable drug delivery. Two trials using the ExAblate 4000 system evaluate repeated BBB opening in Alzheimer’s disease and explore neuromodulation in psychostimulant use disorder. Like hyperbaric oxygen therapy—which delivers 100 % oxygen at pressures two to three times greater than ambient air to aid tissue healing—HIFU uses focused ultrasonic energy to trigger neural responses.
The GVD‑01 vibration device is designed to reduce memory and cognitive decline in early Alzheimer’s disease; its trial uses sham controls, randomization and double‑blinding to explore the efficacy of acoustic‑vibration stimulation. An infrared photo biomodulation system assesses changes in motor and cognitive function in patients with Parkinson’s disease. Phototherapy is known to relieve psoriasis and atopic dermatitis using ultraviolet light, and systemic PBM for Parkinson’s targets reductions in neuroinflammation and improvements in mitochondrial function.
What the digital‑health trend tells us
As noted in August’s approval report, MFDS included hyperbaric oxygen chambers, continuous glucose monitors, digital therapeutics, vestibular‑rehabilitation VR programs and neural stimulators among its authorized trials, underscoring that digital health is central to the medical‑device market. The dominance of digital therapeutics and neuromodulation in May reflects this trend. Because digital therapeutics rely on behavioral and lifestyle changes and are being developed for diseases ranging from diabetes and heart failure to obesity and Alzheimer’s disease, hybrid studies combining non‑drug therapies such as hyperbaric oxygen or phototherapy are increasing. The convergence of 3D‑printed implants and biosignal‑analysis software indicates active development of integrated medical devices.
For pharmaceutical and biotech professionals in Korea and abroad, May’s approvals illustrate evolving clinical‑trial designs and regulatory requirements. Software‑based medical devices and big‑data‑driven biosignal analysis tools now play critical roles at the clinical‑trial stage, while non‑invasive neuromodulation, photobiomodulation and acoustic‑stimulation technologies open new avenues for central‑nervous‑system research. With MFDS strictly verifying the safety and efficacy of digital medical devices, companies must focus on quality management and robust clinical data.
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