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  • What about digital therapy devices awaiting approval
  • by Lee, Hye-Kyung | translator Kim, Jung-Ju | Sep 6, 2023 05:36am
after insomnia improvement products?
14 confirmed confirmatory clinical trial plans approved for 2021-2022
Operating regulatory innovation programs with ¡®big tech¡¯ companies such as Naver, Kakao, and LGU+
 ¡ã Younglim Lee, Head of the Medical Device Review Department
In addition to digital treatment devices for improving insomnia, the Ministry of Food and Drug Safety is expecting applications for licenses for digital treatment devices No. 3 and 4 aimed at improving symptoms in the fields of neurology and psychiatry, respiratory rehabilitation, visual disturbances, and tinnitus. Lee Young-rim, head of the medical device review department at the Korea Food and Drug Safety Evaluation Institute, said in a press briefing for a specialized magazine on the 5th, "As of the end of August, there are 47 digital therapeutic devices for which clinical trial plans have been approved," and "among them, confirmatory clinical trials will be conducted in 2021 and 2022." ¡°As there are 14 products
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