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

Digital Certificate Authentication System Market Size And Share Analysis - Growth Trends And Forecasts (2025-2032)...

The Digital Certificate Authentication System Market is set to witness immense growth during the forecast period 2025-2032. This intelligence report offers an in-depth analysis of the market size, share, growth, opportunity, competitive land...

Digital Platform for Accompanying Medical Service Market Size And Share Analysis - Growth Trends And Forecasts (2025-2032)...

The Digital Platform for Accompanying Medical Service Market is set to witness immense growth during the forecast period 2025-2032. This intelligence report offers an in-depth analysis of the market size, share, growth, opportunity, competit...

Vehicle Bluetooth Digital Key Market Size And Share Analysis - Growth Trends And Forecasts (2025-2032)...

The Vehicle Bluetooth Digital Key Market is set to witness immense growth during the forecast period 2025-2032. This intelligence report offers an in-depth analysis of the market size, share, growth, opportunity, competitive landscape, manuf...

Automotive NFC Digital Key Market Size And Share Analysis - Growth Trends And Forecasts (2025-2032)...

The Automotive NFC Digital Key Market is set to witness immense growth during the forecast period 2025-2032. This intelligence report offers an in-depth analysis of the market size, share, growth, opportunity, competitive landscape, manufact...

Leukocyte Adhesion Deficiency Therapeutics Market Size And Share Analysis - Growth Trends And Forecasts (2025-2032)...

The Leukocyte Adhesion Deficiency Therapeutics Market is set to witness immense growth during the forecast period 2025-2032. This intelligence report offers an in-depth analysis of the market size, share, growth, opportunity, competitive lan...

Healthcare Cognitive Computing Market Size And Share Analysis - Growth Trends And Forecasts (2025-2032)...

The Healthcare Cognitive Computing Market is set to witness immense growth during the forecast period 2025-2032. This intelligence report offers an in-depth analysis of the market size, share, growth, opportunity, competitive landscape, manu...

Advanced Dental Digital and Robotics Solutions Market Size And Share Analysis - Growth Trends And Forecasts (2025-2032)...

The Advanced Dental Digital and Robotics Solutions Market is set to witness immense growth during the forecast period 2025-2032. This intelligence report offers an in-depth analysis of the market size, share, growth, opportunity, competitive...

Digital Therapeutics & Medical Devices for Migraine Market Size And Share Analysis - Growth Trends And Forecasts (2025-2032)...

The Digital Therapeutics & Medical Devices for Migraine Market is set to witness immense growth during the forecast period 2025-2032. This intelligence report offers an in-depth analysis of the market size, share, growth, opportunity, compet...

Digital Health In The Neurology Market Size And Share Analysis - Growth Trends And Forecasts (2025-2032)...

The Digital Health In The Neurology Market is set to witness immense growth during the forecast period 2025-2032. This intelligence report offers an in-depth analysis of the market size, share, growth, opportunity, competitive landscape, man...

Digital Twins in Healthcare Market Size And Share Analysis - Growth Trends And Forecasts (2025-2032)...

The Digital Twins in Healthcare Market is set to witness immense growth during the forecast period 2025-2032. This intelligence report offers an in-depth analysis of the market size, share, growth, opportunity, competitive landscape, manufac...