Medical device manufacturers’ plans for clinical trials on filler development won the most regulatory nods last year, government data showed Wednesday.
According to the Ministry of Food and Drug Safety, the number of approved clinical trials for fillers was eight, the highest among the total of 84 approvals for studies on medical devices in 2017.
The rising overseas demand for anti-wrinkle filler products boosted the number of clinical trials. Exports of fillers also went up to 213 billion won ($201.7 million) in 2017 from 161.4 billion won a year earlier.
Last year, the regulator also granted a nod to three clinical study plans for artificial intelligence (AI)-based medical devices for the first time in Korea. The approved trials include software to classify types of cerebral infarction, another to measure the bone age of children in growth, and the other to help diagnose solitary pulmonary nodule through X-ray imaging.
Other approved trials for the Fourth Industrial Revolution include a study on a 3D printing technique to regenerate cheekbones artificially, and another on a psychotherapeutic electroencephalography that helps treat dementia through electrical stimulation of the brain.
By type of medical device, 43 clinical plans for medical machinery including personal low-frequency stimulator obtained approval, 25 for medical supplies such as wound dressing, and 16 for in vitro diagnostic agents.
The number of approvals for study plans for in vitro diagnostic agents dropped to 16 last year from 56 in 2016.
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