InnerWave's digital therapeutic device (DTx) for nicotine use disorder, Doctor Jin Nicogini, has been designated as an innovative medical device by the Ministry of Food and Drug Safety (MFDS).
InnerWave's digital therapeutic device (DTx) for nicotine use disorder treatment, 'Dr. Jin Nicogini' [Photo by InnerWave]
InnerWave announced on the 27th that the MFDS designated Doctor Jin Nicogini as the 67th innovative medical device on the 26th. Innovative medical devices are designated by the MFDS as devices that significantly improve safety and efficacy compared to existing medical devices or treatments in fields with high technological intensity and rapid innovation.
Doctor Jin Nicogini is currently undergoing confirmatory clinical trials and was recognized for its technological innovation by digitalizing cognitive behavioral therapy, which was previously conducted in hospitals, enabling treatment at home, leading to its designation as an innovative medical device.
This product consists of a cognitive behavioral therapy and motivational enhancement therapy program in the form of a mobile application. It monitors smoking amount, craving levels, and medication adherence, and based on this data, provides the user's probability of smoking cessation failure using artificial intelligence (AI).
Jinwoo Lee, CEO of InnerWave, said, “The designation as an innovative medical device confirms the innovation and technological excellence of Doctor Jin Nicogini. Along with this, we will focus our technological investments on areas that comprehensively improve nicotine use issues, such as solutions for preventing youth smoking.”
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