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:

Blood Testing Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2014 - 2020
By - Transparency Market Research
Blood testing is a laboratory based analysis that is performed in order to determine general state of health, presence of a bacteria or virus and to assess disease progression. It is usually performed by taking a small sample of blood from the patient’s body with the help of a needle or finger prick. Cancer, cardiovascular diseases, acquired immunodeficiency syndrome (AIDS)/HIV, anemia and diabetes are some major diseases for which blood testing is recommended so as to confirm the diseased condition. Blood testing is also performed in order to assess how well body vital organs such...
Downhole Tools Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2014 - 2020
By - Transparency Market Research
Downhole tools include drilling jars, roller centralizers, drag friction, drill-pipes, fishing tools, shock tools and tubular tools among others. These tools are used in various applications such as oil and gas production, well drilling, well completion and well interventions. The adoption of downhole tools is increasingly seen in well intervention activities due to increasing drilling activities in countries such as U.S and Mexico. In these activities a number of downhole tools used. Some examples of tools used in well intervention include fishing tools, wire-line tools and tubing tools...
Hair Care Market - Global Industry Size, Market Share, Trends, Analysis, And Forecasts 2012 - 2018
By - Transparency Market Research
Introduction of herbal hair care products that help people look younger, and the technological innovations in product manufacturing are some of the factors driving the growth of this industry. The hair care market has experienced rapid growth in the past few years and the trend is expected to continue in future as people are becoming more style conscious than ever before. There are a number of products developed for different end users and hair types, and technological innovations are making these products even more effective and beneficial. Sale of premium shampoo is expected...

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

Ford Recalls 65,000 Fusion Models Due to Issues in Ignition Key
Nov 20, 2014  
If anything defines the world of automobiles currently, it would be recalls. It seems that a flood of automobiles has surrounded the global automobiles industry, which once represented a flourishing and highly profitable industry.  The current automobile giants ordering yet another recall is Ford Motors Co. Ford declared on Tuesday that it is recalling nearly 65,000 sedans from...
3D Printed Heart Model for Better Cardiological Treatment
Nov 20, 2014  
According to research carried out by the American Heart Association’s Scientific Sessions 2014, surgeons will be able to treat complex heart disorders in patients, with the help of a three dimensional experimental printed model of the heart. For surgical planning, most cardiac surgeons make use of two dimensional images of the heart taken by MRI, ultrasound, and X-ray. But the problem is...
Los Angeles Auto Show Kicks Off
Nov 20, 2014  
The Los Angeles Auto Show kicked off on Wednesday with a rather upbeat mood. Motoring machines, industry metrics, and hybrid models – the show has lived up to its reputation once more. The Los Angeles Auto Show has begun touring North America from the Los Angeles Convention Center, and the commencement has already had an impact on the market. Gasoline prices dropped under US$3...
Scottish Government to Inject 200 Million Pounds in the Housing Sector
Nov 19, 2014  
The construction and the housing industries of Scotland will get a major financial boost from the Scottish government in terms of additional funding worth 200 million pounds. The main rationale of such a financial boost is to stimulate the housing sector and also safeguarding employment in the construction industry. The housing minister of Scotland has requested the housing leaders to work...
Quarterly Dividend of $0.10 Declared by Tyson Foods, Inc.
Nov 19, 2014  
A quarterly dividend on November 18th was declared by Tyson Foods, reported Analyst Ratings Network.com. The shareholders of the February 27th record will be awarded a dividend of 0.10 per share on March 13th.  This represents a yield of 0.94% and a $0.40 dividend on an annualized basis. However, the ex-dividend date of this particular dividend is February 25th.  Such...