What about digital therapy devices awaiting approval

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+

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 for which the trial plan has been approved, it is expected that the application for approval will be made as soon as the clinical trials are completed,” he said.

 

Digital therapeutic devices are software medical devices that provide evidence-based therapeutic intervention to patients to prevent, manage, and treat medical disorders or diseases.

 

Instead of drugs or injections, digital therapeutic devices stimulate organs, tissues, and nerves with electric ultrasounds, etc.

 

to treat diseases.

 

It provides a treatment method different from Electroceutical, which refers to an electronic device that produces a treatment effect.

 

Currently, there are two products approved as digital therapy devices in Korea, DTx/Digital Therapeutics Somzz and WELT-I, which treat insomnia by installing a mobile app on a smartphone after consulting a doctor.

 

Since it has not yet been approved by health insurance, it has not yet been used in clinical settings, and the effectiveness of its actual use information, or performance has not been verified.

 

Director Lee said, “Only when it is used in clinical settings will we be able to hear the opinions of doctors, patients, etc.,” and added, “As it has not yet been used in medical treatment, it appears that time will be needed to collect information or investigate its effects.” Regarding items expected to be approved after the digital treatment device for insomnia, 64% of products approved for confirmatory clinical trials also represent these fields, perhaps because items 1 and 2 are diseases in the neurological and psychiatric fields.

 

Confirmatory clinical plans were approved for rehabilitation (respiratory, orthopedic) 21% and 15% other than neuropsychiatric fields such as generalized anxiety disorder, mild cognitive impairment, alcohol/nicotine disorder, depressive disorder, and eating disorder.

 

Manager Lee said, “As two products have been approved for the treatment of insomnia, many people are waiting for digital treatment devices for various diseases.” He added, “Recruiting patients for clinical trials requires IRB approval, but recruiting patients has been difficult due to COVID-19.

 

“There was an aspect.

 

It is expected that clinical trials will be conducted for many products starting this year.” The expected digital therapy device is one aimed at improving rehabilitation, and clinical trials are underway for a variety of products, including devices for respiratory rehabilitation for elderly patients.

 

He also added that he is conducting various discussions with IT companies called 'Big Tech' to improve regulations on cutting-edge medical products.

 

Director Lee said, “We held on-site consultation meetings with big tech companies such as Naver, Kakao Healthcare, LGU+, KT, and Kakao Brain and identified requirements for regulatory improvement and support.” He added, “Considering the characteristics of generative artificial intelligence medical devices, they are approved as medical devices.” “We decided to prepare licensing and review guidelines that can be used when entering overseas markets and provide consulting and support for licensing, such as clinical trials and verification,” he explained.

 

Regarding Naver, Lunit, Welt, etc.

 

developing ChatGPT in the medical field and examining the possibility of using it for AIMD, Director Lee is working with industry-academic cooperation experts to develop the "Generative AIMD Permission/Examination Guidelines" by November 2024.

 

“We will develop it,” he emphasized, adding, “We are trying to establish screening standards for safety and effectiveness when it is approved as a medical device.”