Medical Device 3rd Week of Oct 2025

Category Item name Clinical trial title Date of approval
Medical Device Electronic Thermometer A Prospective, Controlled, Single-Center, Confirmatory Clinical Trial to Evaluate the Accuracy and Safety of Core Body Temperature Measurement Using the XST600 Electronic Thermometer Compared to the Control Device (3M SpotOn Thermometer) in Patients Aged 5 Years and Older 2025-09-10
Medical Device Biomaterial for Tissue Repair A Multicenter, Randomized, Subject- and Evaluator-Blinded, Paired-Design, Prospective, Non-Inferiority, Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of Deep PLUS 1.0 for the Temporary Improvement of Moderate to Deep Bilateral Nasolabial Folds in Adults Compared to Neuramis Deep Lidocaine® (NDL-NNT1) 2025-09-10