Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 6
1.2 List of Figures 6
2 Introduction 7
3 Overview of the Healthcare Reform Bill 8
4 Regulatory Landscape in the US 13
4.1 Overview of Medical Device Regulation 13
4.1.1 Establishment Registration 15
4.1.2 Medical Device Listing 15
4.1.3 New Medical Device Approval Process 16
4.1.4 Quality System Regulation/Good Manufacturing Practices 21
4.1.5 Labeling 21
4.1.6 Medical Device Reporting 22
5 Changing Reimbursement Scenario in the Medical Device Market 24
5.1 Cardiovascular Devices 24
5.1.1 Reimbursement Coverage for Transcatheter Aortic Valve Replacement 24
5.1.2 Reimbursement Coverage for Artificial Hearts and Related Devices 26
5.1.3 Reimbursement Coverage for Percutaneous Transluminal Angioplasty 28
5.2 Neurostimulation Devices 30
5.2.1 Reimbursement Coverage for Transcutaneous Electrical Nerve Stimulation 30
5.3 Diagnostic Imaging Devices 32
5.3.1 Reimbursement Coverage for Magnetic Resonance Imaging 32
5.3.2 Reimbursement Coverage for Positron Emission Tomography Scans 33
5.3.3 Reimbursement Cuts for Diagnostic Imaging Services 33
5.4 Endoscopy Devices 34
5.4.1 Reimbursement Coverage for Capsule Endoscope Systems 34
6 Appendix 38
6.1 Definitions 38
6.1.1 Cardiovascular Devices 38
6.1.2 Diagnostic Imaging 38
6.1.3 Neurostimulation Devices 38
6.1.4 Endoscopy Devices 38
6.2 Acronyms 38
6.3 Sources 39
6.4 Research Methodology 41
6.4.1 Secondary Research 41
6.4.2 Primary Research 41
6.4.3 Models 42
6.4.4 Forecasts 42
6.4.5 Expert Panels 42
6.5 Contact Us 42
6.6 Disclaimer 42