As defined by the FDA, Digital Therapeutics (DTx) is a "Software as a Medical Device (SaMD) that provides evidence-based therapeutic interventions to non-patients for the purpose of preventing, managing, or treating a medical disorder or disease based on biometric information collected from general-purpose digital devices such as smartphones, tablet PCs, and wearable medical devices."
Currently, the domestic Digital Therapeutics industry is in its infancy. As of June 2023, only *** products have been recently approved, but they have not yet been used in earnest because the payment system has not yet been established by health insurance. Therefore, there is no market to estimate the size.
Currently, companies developing digital therapeutic devices are mostly ICT-based startups rather than traditional medical device developers. They are known to receive equity investment from large domestic pharmaceutical companies to develop their technologies, or to contract with pharmaceutical companies in advance for distribution rights at the pre-commercialization stage.
As of 19 May 2023, there are a total of *** digital therapeutic device products designated as innovative medical devices in Korea, and for each product, we examined the product development and launch trends to date.
In Korea, Aimmed's Somzz was the first to be approved on 2023-02-15, followed by Welt Corporation's Pillow Rx on April 19 of the same year as the second Digital Therapeutics.

Terms and Definitions
Disclaimer
Preface

1 Understanding Digital Therapeutics
1.1 Definition of DTx
1.2 Characteristics of Digital Therapeutics
1.3 Development History of Digital Therapeutics
1.4 Applications of Digital Therapeutics
1.5 Global Digital Therapeutics Market

2 DTx Market in Korea
2.1 Breakthrough Device Designation
2.2 Product Approval of MFDS
2.3 NHIS Listing and Coverage
2.3.1 Breakthrough Technology Designation
2.4 Clinical Trial Approval of MFDS
2.5 Current R&D in Korea

3 Major Suppliers of DTx in Korea
3.1 NUNAPS
3.2 DoBrain
3.3 LifeSemantics
3.4 S-Alpha Therapeutics
3.5 AIMMED
3.6 WELT
3.7 Other Suppliers
3.7.1 Neudive
3.7.2 Medimind (formerly known as F&I Korea)
3.7.3 Emocog
3.7.4 HAII
3.7.5 Huraypositive

4 Business Issues in DTx Market
4.1 Scope of DTx Classified as Medical Devices
4.2 Scope of Reimbursement DTx
4.3 Market Access Model of DTx in Korea
4.3.1 Target Conditions and Intended Uses
4.3.2 Clinical Grounds
4.3.3 Outlook for NHIS Coverage
4.3.4 Business Model Forecast

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