Illustration by Min-kyun Son

The Ministry of Food and Drug Safety announced on the 15th that it designated 29 products utilizing advanced technologies such as big data, artificial intelligence (AI), mobile applications, and virtual reality (VR) as 'innovative medical devices' last year.

Innovative medical devices are products that apply advanced technologies such as information and communication technology and biotechnology, significantly improving or expected to improve safety and efficacy compared to existing medical devices or treatments. Since the inception of this system in 2020, a total of 88 products have been designated as innovative medical devices.

Last year, the number of applications for innovative medical device designations increased by 137% compared to the previous year's 79 cases, reaching a total of 108. However, the Ministry noted that some products did not complete the review, resulting in a decrease of 2 designated products from the previous year.

Looking at the products designated last year by type, medical device software (SW) utilizing AI technology accounted for 23 cases (79%), maintaining the largest share for the second consecutive year. Instruments and machinery, as well as in vitro diagnostic medical devices, accounted for 5 cases (17%) and 1 case (4%), respectively.

Among them, URO dot AI, developed by Idot, is a software that utilizes AI algorithms based on CT (computed tomography) images to automatically detect urinary stones smaller than 3㎚. The intravenous blood collection automation solution AIIV, developed by Airs Medical, selects veins suitable for blood collection using ultrasound images and AI and robotic control technology, then automatically collects blood. The physical therapy instrument innk-P01 developed by Neurofit helps restore the consciousness function of patients with long-term consciousness disorders by establishing treatment plans based on MRI (magnetic resonance imaging) images and using electrical stimulation.

The corporations developing innovative medical devices last year included VIVID BRAIN, a cognitive therapy software developed by NewNaps, VUNO's ophthalmic image detection and diagnostic support software VUNOmed, SK's brain image detection and diagnostic support software 'Medical Insight Plus Cerebral Hemorrhage', iInnerWave's cognitive therapy software 'Dr. Jin Nicogeny', TI's ophthalmic electrosurgical unit 'iMES', NeuroMus's attachable ultrasound stimulation system 'NMS-01', ImoCog's cognitive therapy software 'Cogtera', and Beyond Medicine's dental treatment software 'Clickless Digital Therapeutics (Clickless DTx)'.

Lee Nam-hee, director of the Medical Device Safety Bureau at the Ministry of Food and Drug Safety, stated, "In 2025, to expand treatment opportunities, we will actively support the rapid market entry of innovative medical devices utilizing advanced technologies, including applying priority reviews under GMP (Good Manufacturing Practice) standards," adding, "The target will also continue to expand."