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Title Clinical evaluation of medical devices / edited by Karen M. Becker, John J. Whyte.
Imprint Totowa, N.J. : Humana Press, ©2006.


 Internet  Electronic Book    AVAILABLE
Edition 2nd ed.
Description 1 online resource (x, 346 pages) : illustrations
Bibliog. Includes bibliographical references and index.
Note Available only to authorized UTEP users.
Subject Medical instruments and apparatus -- Evaluation.
Clinical trials.
Equipment and Supplies -- standards.
Clinical Trials -- standards
Device Approval -- standards.
Evaluation Studies
Contents Clinical trials in development and marketing of medical devices / Karen M. Becker -- Regulatory requirements for clinical studies of medical devices and diagnostics / Daniel A. Kracov and Lisa M. Dwyer -- Requirements for medicare coverage and reimbursement for medical devices / Esther R. Scherb and Stuart S. Kurlander -- Postmarket requirements for significant risk devices / Suzan Onel -- Applications of bayesian methods to medical device trials / Richard Simon and Telba Z. Irony -- Intellectual property protection for medical devices / Faffi Moazzam and Michael D. Bednarek -- HIPAA compliance in clinical research / Peter M. Kazon and Sharon D. Brooks.
Overview of medicare coverage of clinical trials / Julie K. Taitsman -- Developing drug-device combination products with unapproved components / Guy Chamberland -- Wall Street's perspective on medical device evaluation / Adam K. Galeon -- Challenges in conducting implantable device trials: left ventricular assist device in destination therapy / Davis Ascheim, Michael Parides, and Alan J. Moskowitz -- BELIEF: a randomized, sham-procedure-controlled trial of percutaneous myocardial laser therapy / Jan Eric Nordrehaug.
Clinical trials of an anti-adhesion adjuvant / Michael P. Diamond -- Use of multiple imputation models in medical device trials / Donald B. Rubin and Samantha R. Cook -- Case studies on local coverage process / Michael I. Burken -- Reimbursement analysis: from concept to coverage / Robin Bostic -- Polyurethane pacemaker leads: the contribution of clinical experience to the elucidation of failure modes and biodegradation mechanism / Ken Strokes -- Role of device retrieval and analysis in the evaluation of substitute heart valves / Frederick J. Shoen -- Home prothromin monitoring: evidence-based medicine exemplified in the medicare coverage process / John J. Whyte.
Summary Summarizes the key principles and approaches employed in medical device clinical trials and illustrate their uses. This book includes information on the requirements and process for gaining reimbursement from Medicare and private insurers on new products, including case studies of research designed for this purpose.
Other Author Becker, Karen M.
Whyte, John J., 1966-
Other Title Print version: Clinical evaluation of medical devices. 2nd ed. Totowa, N.J. : Humana Press, ©2006 1588294226 1597450049
Other Title Clinical evaluation of medical devices: principles and case studies