Chapter 1 Concept of Medical AI

Chapter 2 Understanding Medical AI
   2.1 Definition
   2.2 Development Process
   2.3 Applications

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

Chapter 4 Major Suppliers of Medical AI
   4.1 DEEPNOID
   4.2 Lunit
   4.3 VUNO
   4.4 INFINITT Healthcare
   4.5 JLK
   4.6 Coreline Soft Co
   4.7 Heuron
   4.8 Other Suppliers

Chapter 5 Business Strategy Suggestions
   5.1 Eligibility for Medical AI as Medical Device
   5.2 Expectations for AI-Enabled Medical Imaging
   5.3 Market Access Model of AI-Enabled Medical Devices
   5.4 Comparison of Market Access Models

Appendix 1 AI-Enabled Medical Device Approvals (as of April 2022)
Appendix 2 Clinical Trials on AI-Enabled Medical Device

[Table 1] Medical Data Types and Analysis Methods
[Table 2] Medical AI Applications
[Table 3] Examples of AI-Enabled Medical Devices
[Table 4] Development History of AI-Enabled Medical Devices in Korea
[Table 5] Names of AI-Enabled Medical Device Products Approved
[Table 6] AI-Enabled Medical Device Products Approved 2018-2022
[Table 7] Breakthrough Device Designation on AI-Enabled Medical Devices (as of 27 March 2023)
[Table 8] New Health Technology Assessment Criteria for AI-Enabled Medical Devices
[Table 9] New Health Technology Assessment Methods for AI-Enabled Medical Devices
[Table 10] New Health Technology Notifications - AI-Enaled Ischemic Stroke Type Determination Using Magnetic Resonance Imaging
[Table 11] New Health Technology Assessment Suspended - ISYNCBRAIN MCI CLASSIFIER
[Table 12] New Health Technology Assessment Suspended - VUNO MED DEEPCARS
[Table 13] New Health Technology Assessment Suspended - AITRICS-VC
[Table 14] Current New Health Technology Assessments Suspended
[Table 15] Breakthrough Technology Designation Criteria
[Table 16] Potential Value Assessment of Breakthrough Technoogy
[Table 17] Breakthrough Technologies Being Assessed (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 16 March 2023)
[Table 20] Major Companies' R&D on Medical AI 2022-2023
[Table 21] Clinical Trial Approvals on AI-Enabled Medical Devices 2017-2023
[Table 22] Clinical Trial Approvals on AI-Enabled Medical Devices in Korea 2022-2023 (as of 14 March 2023)
[Table 23] AI-Enabled Medical Device Market Size in Korea 2020-2022
[Table 24] DeepNoid Products Launch and Development
[Table 25] Annual Revenues of Deepnoid 2020-2022
[Table 26] Lunit Products Launch and Development
[Table 27] Annual Revenues of Lunit 2020-2022
[Table 28] VUNO Products Launch and Development
[Table 29] Annual Revenues of VUNO 2020-2022
[Table 30] Infinitt Healthcare Products Launch and Development
[Table 31] Annual Revenues of Infinitt Healthcare 2020-2022
[Table 32] JLK Products Launch and Development
[Table 33] Annual Revenues of JLK 2020-2022
[Table 34] CorelineSoft Products Launch and Development
[Table 35] Annual Revenues of CorelineSoft 2020-2022
[Table 36] Heuron Products Launch and Development
[Table 37] Annual Revenues of Heuron 2020-2022
[Table 38] Major Suppliers and AI-Enabled Medical Devices
[Table 39] Comparison of AI-Enabled Medical Device Market Access Models

[Fig 1] Composition of AI-Enabled Medical Devices
[Fig 2] Total Life Cycle of Medical Services and AI Utilization
[Fig 3] Integrated Review Process of Breakthrough Device Designation
[Fig 4] Related Diseases and Member Organizations of Doctor Answer
[Fig 5] IDE Approvals of AI-Enabled Medical Devices
[Fig 6] Screen Image of NEEP:NEURO
[Fig 7] MEDIHUB STROKE, Total Stroke Solution by JLK Inc.
[Fig 8] Aview LCS by Coreline Soft Ltd.
[Fig 9] Market Access Strategy of AI-Enabled Medical 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