ResearchMoz

Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market

GBI Research
Published Date » 2013-05-03
No. Of Pages » N/A
   
 GBI Research’s report Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market looks at the regulatory landscape and reimbursement scenario in the US for four medical device markets: cardiovascular devices, neurostimulation devices, diagnostic imaging devices and endoscopy devices.  
   
 The report provides comprehensive information on establishment registration, medical device listing, Premarket Notification (510k) or Premarket Approval (PMA), Investigational Device Exemption (IDE) for clinical studies, Quality System (QS) regulation, labeling requirements, and Medical Device Reporting (MDR). The report also reviews the reimbursement scenario in these medical device markets. It is built using data and information sourced from proprietary...
Table of Content

1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 4

2 Executive Summary 5
2.1 Obtaining Marketing Clearance for Medical Devices Involves Three Essential Steps 5
2.2 The US Transcatheter Heart Valves Market is Forecast to Witness High Growth Between 2012 and 2019 due to Favorable Reimbursement 5
2.3 Strong Reimbursement Framework is Expected to Drive the US Endoscopy Device Market 6

3 Introduction 8

4 Overview of the Healthcare Reform Bill 9

5 Regulatory Landscape in the US 17
5.1 Overview of Medical Device Regulation 17
5.1.1 Establishment Registration 18
5.1.2 Medical Device Listing 19
5.1.3 New Medical Device Approval Process 19
5.1.3.1 Premarket Notification or 510(k) 21
5.1.3.2 Premarket Approval 23
5.1.3.3 Other Device Regulations 24
5.1.4 Quality System Regulation/Good Manufacturing Practices 24
5.1.5 Labeling 25
5.1.6 Medical Device Reporting 26

6 Changing Reimbursement Scenario in the Medical Device Market 28
6.1 Cardiovascular Devices 28
6.1.1 Reimbursement Coverage for Transcatheter Aortic Valve Replacement 28
6.1.1.1 Transcatheter Heart Valves Market in the US is Expected to Exceed $3 billion by 2019 at a CAGR of 45% 29
6.1.2 Reimbursement Coverage for Artificial Hearts and Related Devices 30
6.1.2.1 Left Ventricular Assist Devices Market in the US is Expected to More than Double during the Forecast Period 31
6.1.3 Reimbursement Coverage for Percutaneous Transluminal Angioplasty 32
6.2 Neurostimulation Devices 34
6.2.1 Reimbursement Coverage for Transcutaneous Electrical Nerve Stimulation 34
6.3 Diagnostic Imaging Devices 36
6.3.1 Reimbursement Coverage for Magnetic Resonance Imaging 36
6.3.2 Reimbursement Coverage for Positron Emission Tomography Scans 37
6.3.3 Reimbursement Cuts for Diagnostic Imaging Services 38
6.4 Endoscopy Devices 38
6.4.1 Reimbursement Coverage for Capsule Endoscope Systems 38
6.4.1.1 Capsule Endoscopy Systems Market in the US is Expected to Double during the Forecast Period 40

7 Appendix 43
7.1 Definitions 43
7.2 Acronyms 43
7.3 Sources 44
7.4 Research Methodology 46
7.4.1 Secondary Research 46
7.4.2 Primary Research 46
7.4.3 Models 47
7.4.4 Forecasts 47
7.4.5 Expert Panels 47
7.5 Contact Us 47
7.6 Disclaimer 48

List of Tables

Table 1: Food and Drug Administration, US, Classification Regulations 20
Table 2: Food and Drug Administration, US, Device Labeling 25
Table 3: Food and Drug Administration. US, Reporting Requirements for Manufacturers 26
Table 4: Food and Drug Administration, US, Reporting Requirements for User Facilities 26
Table 5: Transcatheter Heart Valves Market, US, Revenue Forecast ($m), 2012–2019 29
Table 6: Left Ventricular Assist Devices Market, US, Revenue Forecast ($m), 2012–2019 31
Table 7: Capsule Endoscope Systems Market, US, Revenue Forecast ($m), 2012–2019 41

List of Figures


Figure 1: Transcatheter Heart Valves Market, US, Revenue Forecast ($m), 2012–2019 6
Figure 2: Key Healthcare Reform Provisions, US, 2010 10
Figure 3: Key Healthcare Reform Provisions, US, 2010 11
Figure 4: Key Healthcare Reform Provisions, US, 2010 12
Figure 5: Key Healthcare Reform Provisions, US, 2010 13
Figure 6: Key Healthcare Reform Provisions, US, 2010 14
Figure 7: Key Healthcare Reform Provisions, US, 2010 15
Figure 8: Key Healthcare Reform Provisions, US, 2010 16
Figure 9: Key Healthcare Reform Provisions, US, 2010 16
Figure 10: Food and Drug Administration, US, Organizational Structure 17
Figure 11: Food and Drug Administration, US, Basic Regulatory Requirements 18
Figure 12: Food and Drug Administration, US, Regulations for Approval of New Medical Device 22
Figure 13: Transcatheter Heart Valves Market, US, Revenue Forecast ($m), 2012–2019 29
Figure 14: Left Ventricular Assist Devices Market, US, Revenue Forecast ($m), 2012–2019 31
Figure 15: Capsule Endoscope Systems Market, US, Revenue Forecast ($m), 2012–2019 41

Upcoming Reports:

Epichlorohydrin Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2012 - 2018
By - Transparency Market Research
Epichlorohydrin (ECH) is an organochlorine compound and an epoxide. It contains an organic compound having at least one chlorine covalent bond and cyclic ether rings. This is the compound mainly used for the production of epoxy resins which are used in coating, adhesives, and plastics. However, it is also used in manufacturing commercial pesticides. There are several other applications of epichlorohydrin as well. The epichlorohydrin market is expected to show growth in the coming future because of the increasing variety of uses in different product manufacturing processes....
Poland: market of machinery for sugar manufacturing
By - Williams and Marshal Strategy
This report presents a comprehensive overview of the machinery for sugar manufacturing market in Poland and its state as of January 2014. It provides detailed analysis of the industry, its dynamics and structure. The purpose of the report is to describe the state of the machinery for sugar manufacturing market in Poland, to present actual and retrospective information about the volumes and dynamics of production, imports, exports and consumption, the characteristics of the market for the period 2008-2012 and to build a forecast for the market development until 2018. In the same way, the...
Medical Image Processing Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2014 - 2020
By - Transparency Market Research
Medical imaging refers to the visualization of the body parts, organs, tissues or cells for clinical diagnosis, disease monitoring and treatment. The imaging techniques used in medical devices include variety of modern equipments in the field of optical imaging, nuclear imaging, radiology and other image-guided intervention. The radiological method renders anatomical and physiological of the human body at a very high spatial and temporal resolution. The radiology discipline covers m ethods such as ultrasound, CT scan, X-ray, MRI and other similar devices. Whereas, the optical imaging...

Research Assistance

We will be happy to help you find what you need.
Please call us or write us:

866-997-4948 (Us-Canada Toll Free)
Tel: +1-518-618-1030
Email: sales@researchmoz.us
Select License type:

Share this report

Related News

A Health Tech Incubator Started by GE Healthcare
Oct 30, 2014  
For the very first time, a health tech start up campus has been established by GE Healthcare at its headquarters at Helsinki, Finland. This area already has about twenty such healthcare start ups that are working on cloud services, wireless technologies, apps, and sensors that aim at improving healthcare. The main rationale behind such a step is providing opportunities for further...
Net Earnings of DuPont Increases 52% despite Agricultural Turmoil
Oct 29, 2014  
DuPont - The Wilmington, Del-based leading chemical company faced decline of three percent sales to $7.5 billion in the quarter ending of September 30. The company’s third-quarter earnings were increased by 52 percent to $433 million albeit the slow global growth and agricultural downside.   The company witnessed the biggest drags from chemical sales with eight percent...
Appeal for Sanitization in Construction Industry through Government Regulations: CIOB Ghana
Oct 29, 2014  
Rockson Dogbegah - The Chairman of the Chartered Institute of Building Ghana commented that the construction industry needs a thorough cleaning up and assurance of proper growth. Mr. Dogbegah also said that a few factors are extremely important for a proper development in the construction industry. These include keen adherence to standards, supreme sense of professionalism, and sheer pursuance...
Facebook Hints of Rise in Expenses in 2015, Shares Drop
Oct 29, 2014  
Facebook has announced on Tuesday that it is prepping for a dramatic rise in spending in the year 2015. This warning has come combined with a projected slowdown in the company’s revenues after revenues were analyzed at the end of the third quarter of the year. The plans of such hefty spending in the next financial year by the company are indicative of stress in the investor...
Samsung Records Poorest Profits in Q3 2014
Oct 29, 2014  
In the quarter ending September 2014, Samsung Electronics Co. Ltd registered the smallest earnings ever in two years. The drop in earnings can be easily attributed to heavy competition from new Chinese devices and the Apple phones. The net income stood at US$4 billion for the South Korea-based company. Apple has been Samsung’s strongest contender ever since the latter entered the...