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

510k) or PMA, IDE for clinical studies, QS regulation, labeling requirements, and MDR.

- Information on reimbursement coverage in the US for cardiovascular devices, neurostimulation devices, diagnostic imaging devices and endoscopy devices.

- Annualized market revenue data, forecast to 2018, for the transcatheter heart valves market, left ventricular assist devices market and endoscopy devices market.

- Qualitative analysis of key trends in the US regulatory and reimbursement landscape.

 

Reasons to buy

 

- Develop business strategies by understanding the reimbursement trends in the US medical devices market.

- Design and enhance your product development, marketing, and sales strategies.

- Develop market-entry and market expansion strategies.

- Identify, understand and capitalize on the next big thing in the US medical devices market landscape.

- Make more informed business decisions from the insightful and in-depth analysis of the US medical devices market and the factors shaping it.

 

 

 

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 Cove
'/>"/>

SOURCE Reportlinker
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. NFLPA and THERAPEARL, LLC Partner to Provide Athletes with Game Changing Innovations in Hot and Cold Pack Therapy
2. NxStage Submits Formal Comments to CMS to Improve Patient Access to Life-changing More Frequent Home Hemodialysis Therapy
3. New Knee Implant Is Changing The Way Patients And Surgeons View Revision Hinged Knee Replacement
4. Personal Connections Drive Employee Participation For Changing Tomorrow Day at Astellas
5. Hologic to Showcase Game-Changing Breast Tomosynthesis Technology and Other Product Innovations at the European Congress of Radiology in Vienna
6. Frost & Sullivan Recognizes KAERs Game-Changing Innovating Aerosol Drug Delivery Methods for High-Dose Respiratory Disease Therapeutics
7. Frost & Sullivan Honours CapsoVision for CapsoCam SV-1, its Game-changing Gastrointestinal Capsule Endoscope
8. FDA Cleared ChromaGen Lenses Are A Life-Changing Aid For People Struggling With Dyslexia And Other Reading Problems
9. Thoma & Sutton Eye Care Launches ChromaGen Life-Changing Lens Technology
10. ChromaGen Launches Life-Changing Lens Technology In Houston, Texas
11. Sensitech Inc. Products Receive Regulatory Compliance Approval from IATA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/1/2015)... The Haselmeier Group has decided to reinforce ... has been nominated by the Board of Directors ... (CEO) of the Haselmeier Group. This nomination is ... brings more than 20 years of experience in the ... management positions, the last being Managing Director and Vice ...
(Date:6/30/2015)... -- Inventor of ProTide technology ...   NuCana, a clinical stage biopharmaceutical company ... portfolio of novel anti-cancer medicines, today announced the appointment ... Officer. Professor McGuigan was the original inventor ... Medicinal Chemistry at the Cardiff School of Pharmacy and ...
(Date:6/30/2015)... Ansell, a global leader in protection solutions, ... Ansell Cares ® H.E.R.O. Service Award ... organised in partnership with the European Operating Room Nurses ... and quality in patient care, and present an in-depth ... taking place today in the winners, respective hospitals in ...
Breaking Medicine Technology:Haselmeier Group Announces the Extension and Reorganization of its Executive Board 2Internationally Renowned Medicinal Chemist Professor Chris McGuigan Appointed as NuCana's Chief Scientific Officer 2Internationally Renowned Medicinal Chemist Professor Chris McGuigan Appointed as NuCana's Chief Scientific Officer 3Ansell Announces European O.R. Nurse Hero Award Winners 2Ansell Announces European O.R. Nurse Hero Award Winners 3
... SAN DIEGO, May 5, 2011 /PRNewswire/ -- Halozyme ... developing and commercializing products targeting the extracellular matrix , ... of America Merrill Lynch Health Care Conference in Las Vegas. ... PDT (2:10 p.m. EDT). To listen to the live webcast ...
... 2011 Savient Pharmaceuticals, Inc. (NASDAQ: SVNT ) ... 31, 2011.  Savient ended the quarter with $268.0 million in ... December 31, 2010, primarily due to the issuance and sale ... the first quarter of 2011, the Company had a net ...
Cached Medicine Technology:Halozyme Therapeutics to Present at the Bank of America Merrill Lynch Health Care Conference on May 12 2Savient Pharmaceuticals Reports First Quarter 2011 Financial Results 2Savient Pharmaceuticals Reports First Quarter 2011 Financial Results 3Savient Pharmaceuticals Reports First Quarter 2011 Financial Results 4Savient Pharmaceuticals Reports First Quarter 2011 Financial Results 5Savient Pharmaceuticals Reports First Quarter 2011 Financial Results 6Savient Pharmaceuticals Reports First Quarter 2011 Financial Results 7
(Date:7/1/2015)... ... July 01, 2015 , ... This ... Patient Self-Management (PSM) Solutions at the Society for Human Resource Management (SHRM) Annual ... for over 10 years, can reduce overall cost of care by approximately $1,000 ...
(Date:6/30/2015)... ... July 01, 2015 , ... Avid boxing style rock ... Jimi Hendrix Singer Bowl concert posters. The Who and the Rascals also played at ... According to Hawley, "The Doors played with the Who backing them up. The Doors ...
(Date:6/30/2015)... (PRWEB) , ... July 01, 2015 , ... ... it more responsive and easy to navigate. By making fundamental changes to the ... A representative from the site said, “Finding the right website has been getting ...
(Date:6/30/2015)... ... 2015 , ... Ticket Down is a reliable source for cheap tickets for Journey at ... legendary band has been packing venues for years and they are one of the most ... albums in their career. While Journey is known for their all-around great sound, fans ...
(Date:6/30/2015)... ... ... The Blue Cross and Blue Shield of Minnesota Foundation today announced the award ... community health by focusing on the social and economic factors that greatly affect health ... year in 2016 based on progress in 2015. , “We took a new approach ...
Breaking Medicine News(10 mins):Health News:APhA Foundation to Showcase Newly Introduced Patient Self-Management Solutions at the Society for Human Resource Management (SHRM) Annual Conference and Exposition 2Health News:Avid Boxing Style Rock Concert Poster Collector From Vintage Rock Posters Announces Search for 1968 Doors and Jimi Hendrix Singer Bowl Concert Posters 2Health News:HerpesDatingSites.org Introduces a New Responsive Design 2Health News:Journey Tickets at The Stadium of Fire at Lavell Edwards Stadium in Provo, Utah: Ticket Down Slashes Ticket Prices for Journey on the 4th of July in Provo 2Health News:Blue Cross and Blue Shield of Minnesota Foundation Awards $1.5 Million 2
... domestic violence endure significantly higher health costs than other women ... finds. Abuse victims had health care costs that averaged ... years after the abuse ended and about $400 above others ... physical and emotional consequences even years after their abuse ends, ...
... healthy, financially secure and with a desire to travel. According ... remain among the most self-reliant generations to reach their golden ... They won,t stop being self-reliant when they get old and ... as he,s done at various national and international conferences. ...
... some patients suffered side effects, including reduced strength after ... -- Botulinum toxin, which smoothes facial wrinkles through injections ... suffer from "tennis elbow," a new study finds. , ... carefully, and there,s a potentially nettlesome side effect, according ...
... Adult content changes kids, personalities, one expert says, , ... allowed to watch R-rated movies are much less likely ... new study suggests. , Researchers questioned nearly 3,600 middle-school ... later. In that time, 3 percent of the kids ...
... and Springer Science+Business Media have launched a new textbook ... language set is of fundamental significance for the subject. ... the School of Chinese Medicine HKBU, the books were ... China and the USA. Representatives from HKBU, as well ...
... April 2010 - Elsevier, the world-leading publisher of ... proudly announces the release of a brand-new single ... mitral valve disease by the internationally renowned cardiac ... will launch at the 90th Annual Meeting of ...
Cached Medicine News:Health News:Domestic violence victims have higher health costs for years after abuse ends 2Health News:Domestic violence victims have higher health costs for years after abuse ends 3Health News:Baby boomers aging to be self-reliant 2Health News:Botox Injections May Relieve Tennis Elbow Pain 2Health News:Watching R-Rated Movies May Lead to Early Alcohol Use 2Health News:Springer Asia launches Chinese medicine textbook series in English 2Health News:Elsevier launches Carpentier's reconstructive valve surgery book 2
Designed to be removed from under surgical gown without compromising sterile fields. Two straps criss-cross in the back and attach with velcro in the front....
Wolfs unique apron and vest set distributes weight evenly between shoulders and hips. The vest comes with an attached Thyroid collar...
... Full frontal protection, our conventional ... shoulders by sturdy 2 webbed ... quick-acting snap hook fasteners. The ... custom fit the apron. Our ...
... Aprons are the result of a technologically ... x-ray aprons. Constructed with a wear resistant, ... the Lead Free aprons exhibit the same ... Each apron weighs approximately 50% less than ...
Medicine Products: