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

Table 1 Types of Medical Data
Table 2 Applications of Medical AI
Table 3 Examples of AI-enabled Medical Devices
Table 4 Development History of AI-enabled Devices in Korea
Table 5 MFDS Product Names of AI-enabled Device
Table 6 MFDS Approvals of AI-enabled Devices 2018-2022
Table 7 BDD for AI-enabled Devices (as of 27 March 2023)
Table 8 New Health Technology Assessment Criteria
Table 9 New Health Technology Assessment Methods
Table 10 New Health Technology Notification - AI Medical Imaging and Stroke
Table 11 nHTA Suspension - iSyncBrain MCI Classifier
Table 12 nHTA Suspension - Vuno Med DeepCARS
Table 13 nHTA Suspension - AITRICS-VC
Table 14 nHTA Suspension (under review) - DrNoon for CVD
Table 15 Breakthrough Technology Designation Criteria
Table 16 Potential Value Assessment of Breathrough Technology
Table 17 Breakthrough Technologies Under Review (as of March 2023)
Table 18 Breakthrough Technology Designation Notifications (as of March 2023)
Table 19 Current R&D on Medical AI in Korea (as of March 16, 2023)
Table 20 Major Companies' R&D on Medical AI 2022-2023
Table 21 Clinical Trial Approvals by AI-based product 2017-2023
Table 22 Clinical Trial Approvals on AI-enabled Devices in Korea 2022-2023
Table 23 AI-enabled Device Market Size in Korea 2020-2022
Table 24 DeepNoid Product Launches and Developments
Table 25 Annual Revunes of DeepNoid 2020-2022
Table 26 Lunit Product Launches and Developments
Table 27 Annual Revenues of Lunit 2020-2022
Table 28 Vuno Product Launches and Developments
Table 29 Annual Revenues of Vuno 2020-2022
Table 30 INFINITT Healthcare Product Launches and Developments
Table 31 Annual Revenues of Infinitt Healthcare 2020-2022
Table 32 JLK Product Launches and Developments
Table 33 Annual Revenues of JLK 2020-2022
Table 34 Coreline Soft Product Launches and Developments
Table 35 Annual Revenues of Coreline Soft 2020-2021
Table 36 Heuron Product Launches and Developments
Table 37 Annual Revenues of Heuron 2020-2021
Table 38 Product Launches and Developments of Major Suppliers
Table 39 Comparison of Market Access Models

Fig 1 Composition of AI-enabled Medical Devices.
Fig 2 Total Life Cycle of Medical Service and AI applications
Fig 3 Integrated Review Process of Breakthrough Device Designation
Fig 4 Related Disease of Dr Answer
Fig 5 IDE Approvals of AI-enabled Medical Devices 2017-2023
Fig 6 Screen Image of DEEP:NEURO
Fig 7 MEDIHUB STROKE, Total Stroke Solution of JLK
Fig 8 CorelineSoft's AVIEW LCS
Fig 9 Market Access Strategy for AI-enabled Device Companies

1 DEEPNOID
2 Lunit
3 VUNO
4 INFINITT Healthcare
5 JLK
6 Coreline Soft
7 Heuron
8 Roche
9 Medi Whale
10 Samsung Medison
11 Samsung
12 AITrics
13 Siemens Healthineers
14 Claripi