Medical electronics, or more specifically the instrumentation used in physiological measurement, has changed significantly over the last few years. Developments in electronics technology have offered new and enhanced applications, especially in the areas of data recording and analysis and imaging technology. These changes have been accompanied by more stringent legislation on safety and liability. This book is designed to meet the needs of students on the growing number of courses, undergraduate and MSc. It is a concise and accessible introduction offering a broad overview that encompasses the various contributing disciplines.

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There have been revolutionary changes to the classification and regulation of prescription drugs, biologics, and medical devices since the previous edition of this book was published in 1997 under the title Product Development Planning for Health Care Products Regulated by the FDA. The revised book includes: a review of the significant changes within the FDA that affect the requirements and review of medical products; updated facts and figures; expansion of subjects that have grown more critical, such as clinical outcomes, human factors, and marketing objectives; and additional new topics such as the role of product development in hazard analysis, recalls, and product liability. This book is intended as a foundation for anyone involved in product development of pharmaceuticals, biologics, or medical devices. Helpful references include a glossary, acronyms, and a list of useful resources. After reading this book, individuals involved in medical product development, (more…)

Review

Finally, a real manual that for the first time supports efficient medical device development-Peter H. Muller, President, Interform Product DevelopmentThe Keiretsu Forum is America’s largest angel investment group. We see hundreds of presentations for innovative start up companies. This is a resource that will help medical device innovators develop better products, and more focused companies, more quickly-Randy Williams, Founder The Keiretsu ForumThe Keiretsu Forum is Americas largest angel investment group. We see hundreds of presentations for innovative start up companies. This is a resource that will help medical device innovators develop better products, and more focused companies, more quickly-Randy Williams, Founder The Keiretsu ForumThis is the first in its class of multidisciplinary books for medical device innovators, reaching across several disciplines to capture what innovators need-Michael Gertner, MD, Co-Director, Surgical Innovation Program at Stanfo (more…)

Although Reliability Engineering can trace its roots back to World War II, its application to medical devices is relatively recent, and its treatment in the published literature has been quite limited. With the medical device industry among the fastest growing segments of the US economy, it is vital that the engineering, biomedical, manufacturing, and design communities have up-to-date information on current developments, tools, and techniques.Medical Device Reliability and Associated Areas fills this need with broad yet detailed coverage of the field. It addresses a variety of topics related – directly and indirectly – to reliability, including human error in health care systems and software quality assurance. With emphasis on concepts rather than mathematical rigor, a multitude of examples, exercises, tables, and references, this is one resource that everyone connected to the medical device industry must have.

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As the use of three-dimensional ultrasound in clinical practice increases, the need for a reference covering this and other emerging technologies also increases. Edited by acknowledged leaders in the field, with contributions from international experts, An Atlas of Three- and Four-Dimensional Sonography in Obstetrics and Gynecology is just that. The book presents three-dimensional ultrasound images in full color accompanied by extensive captions and expert textual commentary. It provides authoritative coverage of the latest developments in three-dimensional ultrasound in obstetrics and gynecology and highlights cutting-edge technology such as four-dimensional ultrasound.

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Review

“Beautifully presented.. This textbook contains a very comprehensive and well-illustrated review of the role of Doppler sonography in obstetrics and gynecology.”–ASUM Ultrasound Bulletin

This beautifully illustrated and formatted book covers all of the established and developing indications for the use of color Doppler ultrasound in gynecology and obstetrics.  In gynecology the modality is used to measure blood flow in benign changes of the endometrium as well as malignant tumors of the uterus; screening for ovarian carcinoma, including 3D-power doppler for the assessment of angiogenesis of ovarian tumors; and as an adjunct examination in assessing tumors of the breast. In obstetrics, the imaging method is useful in screening for gestosis and placental insufficiency in early pregnancy; evaluating the umbilical cord; fetal echocardiography and much. More recent developments s (more…)

Future generations of vital signs and point-of-care medical devices must interoperate directly and seamlessly with information technology systems to facilitate effective patient care management within the healthcare enterprise. This is the first book addressing medical device integration with the computer-based patient record in a holistic way. Readers step into the area of two-way device communication & control and learn best practises from an author known for his brilliant expertise in this field. It is a fundamental guide for a broad group of people: clinical and biomedical engineers, physicians, bioinformatics practitioners, and vendors. Providing the essential how-to for medical device integration into the electronic medical record (EMR), health information system (HIS), and computerized patient record (CPR), the book highlights information on data extraction, usually not offered by device vendors. This comprises topics such as the use of third-party software, (more…)

Book Description

Univ. of California, San Diego. Textbook presents completely expanded and reorganized coverage. Vol. one covers general ultrasound applications, and volume covers obstetrics and gynecology. Each chapter begins with a list of key terms and definitions and ends with review questions. Previous edition: c1995. For students. Abundantly illustrated. DNLM: Ultrasonography.

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Review

From the reviews of the second edition: “This is a thorough resource on ultrasound imaging of peripheral nerve disease. … It is written for practicing radiologists, neurologists, plastic surgeons, and orthopedic surgeons who are involved in the diagnosis of peripheral nerve disease using ultrasound. … a useful addition to the library of any physician involved in ultrasound imaging of peripheral nerves. This second edition is updated with improved ultrasound images and discussion of recent advances in the literature.” (Julie Sossaman, Doody’s Review Service, August, 2008) “The authors, contributors, and editors have compiled their extensive personal experience, original research … in the fields of anatomy, neurology, and surgery into a textbook that is well written, nicely illustrated, and effortlessly understandable. … this latest addition to the Medical Radiology/Diagnostic Imaging series is indispensable to those interested in using sonography to (more…)

An essential introduction to conducting the various stages of medical device clinical trials Clinical research continues to be one of the most vital components of pharmaceutical, biostatistical, and medical studies. Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials. Written in a style that is accessible to readers from diverse educational and professional backgrounds, this book provides an in-depth and broad overview for successfully performing clinical tasks and activities. Throughout the book, practical examples compiled from both the author’s and other researchers’ previous clinical trial experiences are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report. Next, readers are guided through the devel (more…)