Challenges in Conducting Implantable Device Trials

Autor: Michael K. Parides, Alan J. Moskowitz, Julie C. Choe, Deborah D. Ascheim, Annetine C. Gelijns, Ursula Maria Schmidt-Ott
Rok vydání: 2007
Předmět:
Zdroj: Clinical Evaluation of Medical Devices ISBN: 9781588294227
DOI: 10.1007/978-1-59745-004-1_11
Popis: The medical device industry is characterized by a high level of innovation and the development of a continuous stream of devices that promise to enhance the life expectancy and quality of life of patients. With changes in US Food and Drug Administration (FDA) regulatory policies and increased demand for more rigorous clinical evidence by payors, physicians, and patients alike, there has been more emphasis on randomized trials to evaluate new devices as they move from bench to bedside.
Databáze: OpenAIRE