In this report, medical AI is defined as artificial intelligence used across the healthcare industry. AI-enabled medical devices are in particular referred to devices which assist healthcare providers in diagnosing, managing and/or predicting diseases through analyzing medical big data with artificial intelligence abilities.
AI medical devices are medical devices that apply machine learning models with machine learning (ML) training algorithms to learn medical data and recognize specific patterns to diagnose and predict diseases or provide personalized treatments for patients.
This concept includes both (1) software that analyzes medical data to diagnose, manage, or predict diseases, and (2) software that is conFigured with hardware. However, even if an AI medical device falls under this concept, it may not be classified as a medical device if it does not meet the purpose and risk of use according to the definition of the Medical Device Act in Korea.
In Korea, AI medical devices are most often used to assist in the accurate diagnosis of specific diseases such as cancer and diabetes. It is being utilized not only as a diagnostic aid but also for prevention, treatment, prescription, and prediction throughout the entire medical service cycle. In the future, it is expected that in vitro diagnostic medical devices such as blood glucose meters will be combined with AI software.
According to data from the MFDS, a total of *** AI-enabled medical devices were authorized by April 2022, and *** devices by September 2022. Of those *** devices, *** are imported devices and the rest are domestic devices manufactured in Korea. Currently, there are *** product names excluding the deleted ones from the MFDS Notifications.

Abbreviations and Acronyms
Disclaimer
Preface
Executive Summary

1 Concept of Medical AI

2 Understanding AI-enabled Devices
2.1 Definition
2.2 AI-enabled Device Development Process
2.3 Applications of AI-enabled Devices

3 Current Market of Medical AI in Korea
3.1 Clearances and Approvals
3.1.1 Breakthrough Device Designations
3.2 NHIS Listing
3.2.1 New Health Technology Notifications
3.2.2 New Health Technology Assessment Suspensions
3.2.3 Breakthrough Health Technologies
3.3 Current R&D
3.4 Clinical Trial Approvals

4 Major Suppliers of Medical Ai in Korea
4.1 DEEPNOID
4.2 Lunit
4.3 Vuno
4.4 INFINITT Healthcare
4.5 JLK
4.6 Coreline Soft
4.7 Heuron
4.8 Other Suppliers

5 Business Strategy Suggestions
5.1 Eligibiliry for Medical Device
5.2 Expectations for AI-enabled Medical Imaging
5.3 Market Access Models for AI-enabled Devices
5.4 Comparison of Market Access Models

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