From X-Rays to AI: Navigating US Regulations in Radiological Health
Table of Contents
Chapter 1: Regulatory Oversight of Radiological Health and Imaging Devices
Chapter 2: Diagnostic X-Ray Imaging
Chapter 3: Magnetic Resonance Imaging Systems
Chapter 4: Mammography in the US: The Mammography Quality Standards Act and Beyond
Chapter 5: Diagnostic Ultrasound Systems
Chapter 6: Radiation Therapy and Nuclear Medicine: An Overview of Current Trends
Chapter 7: The Regulation of Software in the Radiological Health Space
Chapter 8: Artificial Intelligence-based Software
Jay Vaishnav, PhD, RAC-Devices and Yuan Fang, PhD, MBA, PEng, RAC-US, editors
About the Book
Available formats: print and e-book
From prenatal ultrasounds to postmortem magnetic resonance imaging (MRI), radiological health devices truly play a key role throughout the spectrum of a person’s life. Radiation products are needed when broken bones or teeth are X-rayed, mammograms are performed, heart conditions are imaged, and cancer is diagnosed or staged via medical imaging exams — the list goes on and on. Given the total-life importance of radiological health devices, it has never been more vital for professionals in the industry to stay up-to-date with US Food and Drug Administration requirements with From X-Rays to AI: Navigating US Regulations in Radiological Health.
Boasting 18 well-regarded author-experts offering cutting-edge information and sound advice over a breezy nine chapters, this one-of-a-kind book removes the mystery behind the FDA’s approach to regulating radiological health devices. Readers will discover the history behind radiological health regulations and learn how radiation products come to the US market.
From X-Rays to AI: Navigating US Regulations in Radiological Health is the first book to focus squarely on diagnostic X-ray imaging, MRI, mammography, ultrasound, and nuclear medicine and radiation therapy, and the current regulatory landscape for each. The book further tackles software and artificial intelligence (AI) — two topics that are of growing importance to the radiation health industry.
Who will benefit from this book?
From X-Rays to AI: Navigating US Regulations in Radiological Health is a helpful resource for all types of readers. The book is useful for an array of radiation health and regulatory professionals, from those new to the industry so they better understand regulatory requirements and hit the ground running to others more familiar with radiation health who are vying for a particular job at their company, to startups attempting to get their products to market, and more. Professionals at Level 1 or 2 of the RAPS Regulatory Competency Framework will discover the best regulatory pathways to take and learn more about particular devices they may be working on. Meanwhile, a Level 3 professional will understand more about the history of radiological health, and a more senior Level 4 professional can make better strategic regulatory decisions.
Purchasing Options
This book can be purchased in the following formats:
- Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
- Printed book.
This book can also be purchased as part of the following bundles:
- All Access Library (12-month digital subscription)
Published by RAPS © 2023. Paperback. 160 pages. ISBN (print): 978-1-947493-93-3. ISBN (digital): 978-1-947493-90-2.
