Clinical evaluation of medical devices / edited by Karen M. Becker, John J. Whyte.

2nd ed.
Totowa, N.J. : Humana Press, c2006.
x, 346 p. : ill. ; 24 cm.


Related name
Bibliographic references
Includes bibliographical references and index.
1. Clinical trials in development and marketing of medical devices / Karen M. Becker -- 2. Regulatory requirements for clinical studies of medical devices and diagnostics / Daniel A. Kracov and Lisa M. Dwyer -- 3. Requirements for Medicare coverage and reimbursement for medical devices / Esther R. Scherb and Stuart S. Kurlander -- 4. Postmarket requirements for significant risk devices / Suzan Onel -- 5. Applications of Bayesian methods to medical device trials / Telba Z. Irony and Richard Simon -- 6. Intellectual property protection for medical devices / Fariborz Moazzam and Michael D. Bednarek -- 7. HIPAA compliance in clinical research / Peter M. Kazon and Sharon D. Brooks -- 8. Overview of Medicare coverage of clinical trials / Julie K. Taitsman -- 9. Developing drug-device combination products with unapproved components / Guy Chamberland -- 10. Wall Street's perspective on medical device evaluation : innovation investing / Adam K. Galeon -- 11. Challenges in conducting implantable device trials : left ventricular assist device in destination therapy / Ursula Maria Schmidt-Ott, Alan J. Moskowitz, Annetine C. Gelijns, Julie C. Choe, Michael Parides and Deborah V. Davis Ascheim -- 12. BELIEF : a randomized, sham-procedure-controlled trial of percutaneous myocardial laser therapy / Jan Erik Nordrehaug and Janet M. Fauls -- 13. Clinical trials of an anti-adhesion adjuvant / Michael P. Diamond -- 14. Use of multiple imputation models in medical device trials / Donald B. Rubin and Samantha R. Cook -- 15. Case studies on the local coverage process / Mitchell I. Burken -- 16. Reimbursement analysis : from concept to coverage / Robin Bostic -- 17. Polyurethane pacemaker leads : the contribution of clinical expertise to the elucidation of failure modes and biodegradation mechanisms / Ken Stokes -- 18. Role of device retrieval and analysis in the evaluation of substitute heart valves / Frederick J. Schoen -- 19. The use of surrogate outcome measures : a case study : home prothrombin monitors / John J. Whyte.
  • 1588294226 (alk. paper)
  • 1597450049 (e-ISBN)
C - S