MFDS Selects Four Innovative Medical Devices Last Month

The Ministry of Food and Drug Safety announced on the 1st that four new products were designated as innovative medical devices last month. The product item names are ‘Medical Peeler,’ ‘Tumor Marker Immunoassay Reagent,’ ‘Cognitive Therapy Software,’ and ‘Electrocardiogram Analysis Software.’

Smartwire’s ‘Smartwire CTR’ is a product developed to resect the wrist ligament compressing the median nerve in patients with carpal tunnel syndrome. It is a product inserted into the wrist with a needle without making an incision on the inside of the wrist, and it is expected that the patient’s recovery will be faster due to less pain and smaller wounds at the surgical site compared to existing surgical methods.

E&S Healthcare’s ‘DxMe BC Kit’ is the first domestic product that quantitatively analyzes ‘Thioredoxin 1 protein’ in the serum of women screened as low-risk for breast cancer using enzyme-linked immunosorbent assay, providing information helpful for breast cancer diagnosis.

Rowan’s ‘Superbrain DEX’ is a product used to improve cognitive function by providing customized cognitive training through artificial intelligence analysis of individual cognitive function levels, age, gender, education, and other basic information of patients with mild cognitive impairment.

DeepCardio’s ‘SmartECG-AF’ is the first domestic product that assists medical professionals’ diagnostic decisions by analyzing ‘12-lead electrocardiogram’ data with artificial intelligence to indicate the potential probability of paroxysmal atrial fibrillation.

Including these four new products, a total of 49 products have been designated as innovative medical devices to date.

This content was produced with the assistance of AI translation services.