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FDA and Intellectual Property Strategies for Medical Device Technologies
This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second port...
Intracranial Pressure And Its Effect On Vision In Space And On Earth: Vision Impairment In Space
Fluid distribution during spaceflight and impact on brain and vision health is an emerging field of high-priority research in the NASA human space program. International Space Station astronauts have developed ocular refraction changes during prolonged spaceflight. Within this book, experts review current data related to fluid shifts during microgravity exposure and the impact of fluid shifts on astronaut health.This work also compares current astronaut health problems with Earth-based health conditions such as elevated intracranial pressure and glaucoma. Chapters include discussion of altered fluid distribution, including intracellular and extracellular fluid shifts, eye morphology and vision disturbances, and intraocular pressure. In addition, chapters will include a discussion of advanced non-invasive technologies to investigate the abovementioned fluid volume and pressure variables.As such, the book aims to bridge health professionals, researchers, and science professionals by a presentation of ophthalmology topics critical to future human space exploration, thus providing new perspectives to solve emerging brain and eye disease on Earth and in Space.
