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Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market
Date:5/21/2013

rage 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

 

 

 

List of Tables

 

Table 1: Food and Drug Administration, US, Classification Regulations 16

Table 2: Food and Drug Administration, US, Device Labeling 21

Table 3: Food and Drug Administration. US, Reporting Requirements for Manufacturers 22

Table 4: Food and Drug Administration, US, Reporting Requirements for User Facilities 22

Table 5: Transcatheter Heart Valves Market, US, Revenue Forecast ($m), 2012-2019 25

Table 6: Left Ventricular Assist Devices Market, US, Revenue Forecast ($m), 2012-2019 27

Table 7: Capsule Endoscope Systems Market, US, Revenue Forecast ($m), 2012-2019 36

 

 

 

List of Figures

 

Figure 1: Key Healthcare Reform Provisions, US, 2010 - A 8

Figure 2: Key Healthcare Reform Provisions, US, 2010 - B 9

Figure 3: Key Healthcare Reform Provisions, US, 2010 - C 9

Figure 4: Key He
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