New Clinical Trials Approved for Medical Devices in July
The Ministry of Food and Drug Safety has granted approval for 14 clinical trials of medical devices this month. Among these, 10 trials are confirmed as confirmatory clinical trials in order to obtain licenses for the devices. The approved trials include the development of skin cancer diagnosis software, orthopedic treatment planning software, and tinnitus treatment device (DTx).
Digital Tinnitus Treatment Device Begins Confirmatory Clinical Trial
The digital tinnitus treatment device (DTx), developed by New Live, is now entering a confirmatory clinical trial phase for medical device approval by the Food and Drug Safety Administration. As a class 2 medical device, the DTx aims to alleviate mental and physical functional disorders caused by subjective tinnitus.
Predictive Software for Very Low Birth Weight Babies
Vistos, a medical software company, has received approval to conduct a confirmatory clinical trial for their fetal monitoring system. This software predicts the risk of postnatal growth failure (PGF) in very low birth weight babies admitted to neonatal intensive care units. By analyzing medical data, the software aims to assist in predicting potential growth retardation at discharge.
Artificial Intelligence-Powered Knee Surgery Planning Software
KabyLab’s DeepPLAN K, an artificial knee joint surgery planning software, has been granted approval for a clinical trial. The trial will evaluate the safety and effectiveness of artificial joint sizing using artificial intelligence. KabyLab is known for their successful orthopedic image treatment planning software, ‘KAVIPLAN-Trauma’.
Medical AI Applications for Chest X-ray Analysis
Deepnoid, a leading medical AI company, has been given the green light to conduct clinical trials for their new software ‘DC-XR-03’. This cutting-edge medical device software detects pulmonary nodule/mass, pleural effusion, and fibrosis by analyzing chest X-ray images. Additionally, JLK’s ‘JBS-LVO’, a software based on artificial intelligence that evaluates the presence or absence of an occlusion, has also been approved for clinical trials.
Clinical Trials for Hardware Medical Devices
Aside from software trials, clinical trials for hardware medical devices have also been approved. Among them, four exploratory trials and two confirmatory trials have been confirmed.
Exploratory Trials for Vagus Nerve Stimulation
An exploratory clinical trial will focus on the vagus nerve stimulator, a medical device that controls nerve movement by inserting electrodes into the body. The trial aims to improve dizziness, particularly persistent positional vertigo. This condition, characterized by ongoing dizziness without significant structural abnormalities, may benefit from vagus nerve stimulation as a potential treatment option.
Further Trials for Central Venous Catheters and Coronary Angioplasty
In addition to the vagus nerve stimulator, clinical trials have been confirmed to evaluate the safety and efficacy of zwitterionic compound coated catheters for cancer patients using central venous catheters. Trials for balloon dilated coronary angioplasty (DCB) and coronary drug-eluting stents (DES) for patients with multivessel coronary artery disease have also been approved.
With these new clinical trials, the Ministry of Food and Drug Safety continues its commitment to ensuring the safety and efficacy of medical devices in the healthcare industry.
The digital tinnitus treatment device (DTx) begins a confirmatory clinical trial for medical device approval by the Food and Drug Safety Administration. During July, the Ministry of Food and Drug Safety approved 14 clinical trials of medical devices (4 to be investigated and 10 to be confirmed), including skin cancer diagnosis software and orthopedic treatment planning software.
Approved 8 SW cases including DTx tinnitus treatment and AI surgical plan
All SW medical device clinical trials approved by the Food and Drug Safety Administration this month were confirmed as confirmatory clinical trials to obtain licenses. △ Tinnitus DTx △ Prediction of growth retardation in very low birth weight △ Detection of human joint size AI, etc.
Ministry of Food and Drug Safety July 2023 Medical Device Clinical Trial Approval Status (Software)
First, New Live, which develops tinnitus-related treatment devices such as DTx and electronic medicine, is conducting a ‘Sound Clear’ DTx tinnitus clinical trial. As a class 2 medical device, it is going to prove the alleviating effect of mental and physical functional disorders caused by subjective tinnitus.
Vistos, with a fetal monitoring system as its core technology, is medical software that predicts the risk of postnatal growth failure (PGF) at discharge based on the medical data of admitted very low birth weight babies to neonatal intensive care. 580 AI’ begins to prove effectiveness. It is a confirmatory clinical trial conducted as a retrospective study comparing existing data.
DeepPLAN K, developed by KabyLab, is an artificial knee joint surgery planning software. In this clinical trial, a safety and effectiveness evaluation of artificial joint sizing using artificial intelligence is carried out. Kavi Lab was previously licensed to export ‘KAVIPLAN-Trauma’ orthopedic image treatment planning software.
In addition, Deepnoid, a company specializing in medical AI, has been approved for a clinical trial of ‘DC-XR-03’, a medical device software that detects pulmonary nodule/mass, pleural effusion, and fibrosis by using chest X-ray images. , and JLK The ‘JBS-LVO’ clinical trial was approved, a software that evaluates the function of diagnosing the presence or absence of an occlusion based on artificial intelligence.
Clinical trials examine medical devices such as catheters and vagus nerve stimulators
For hardware medical devices, four exploratory clinical trials and two confirmatory clinical trials were confirmed. First of all, contact lenses (continuously worn hard contact lenses) and pulse oximeters were listed for confirmatory clinical trials.
Ministry of Food and Drug Safety July 2023 Medical Device Clinical Trial Approval Status (Hardware)
In the exploratory clinical trial, research on the improvement of dizziness (persistent positional perception vertigo) will be carried out on the vagus nerve stimulator, which controls the movement of nerves by inserting electrodes into the body. Persistent positional vertigo is a disease in which the organs of equilibrium such as the ears and brain have no or mild structural abnormalities, but dizziness persists Currently known treatments include △ vestibular rehabilitation exercise △ behavioral therapy cognitive or antidepressants based on serotonin The vagus nerve a stimulus, which attracts attention, will be applied.
In addition, clinical trials to evaluate the safety and efficacy of zwitterionic compound coated catheters in the use of central venous catheters (intravascular cube issues) in cancer patients, and balloon dilated coronary angioplasty for patients with multivessel coronary artery disease Clinical trials for catheters (DCB) and coronary drug-eluting stents (DES) are also confirmed.
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