From X-Rays to AI: Navigating US Regulations in Radiological Health
vii
Preface
Jay Vaishnav, PhD, RAC-Devices
Director of Regulatory Affairs,
RefleXion Medical
Jay Vaishnav, PhD, RAC-Devices, has spent over 25 years working with applications of radiation from
lasers to x-rays. Her career has involved regulatory and clinical strategy roles at startups and multinational
corporations, 10 years of federal service at the Food and Drug Administration and the National Institute
of Standards and Technology, and a year as an Assistant Professor of Physics at Bucknell. She serves on the
RAPS Editorial Advisory Committee and the Devices Regulatory Affairs Certification Board (RACB)
sub-committee. She holds a PhD in physics from Harvard University.
Yuan Fang, PhD, MBA, PEng, RAC-US
Divisional Vice President,
Global Strategic Regulatory,
Abbott Laboratories Inc.
Yuan Fang, PhD, MBA, PEng, RAC-US, currently serves as Divisional Vice President, Global Strategic
Regulatory at Abbott. Throughout his career, Fang has worked in a variety of regulatory and quality roles in
industry and at the US Food and Drug Administration. He holds a PhD in electrical engineering from the
University of Waterloo (Ontario) and is a licensed professional engineer. He has published more than 30
peer-reviewed journal articles, book chapters, conference proceedings, and holds two US patents.
Medical imaging and radiation therapy are indispensable in healthcare. Medical imaging is central to
the diagnosis, monitoring, and treatment of a variety of clinical conditions in 2016, roughly 700 million
radiologic, computed tomography (CT), dental, and nuclear medicine examinations were performed
in the US.1 Radiation therapy is an important part of cancer treatment, received by over half of cancer
patients as part of their treatment.2 Yet despite the number of lives touched by radiological health and
the critical role that radiological health plays in healthcare, few patients or care providers understand
how these devices actually reach the commercial market in the US – a process in which regulatory affairs
plays a major role. Even regulatory affairs experts coming from other device areas are unlikely to have an
in-depth understanding of regulatory considerations specific to radiological health devices, which deal
vii
Preface
Jay Vaishnav, PhD, RAC-Devices
Director of Regulatory Affairs,
RefleXion Medical
Jay Vaishnav, PhD, RAC-Devices, has spent over 25 years working with applications of radiation from
lasers to x-rays. Her career has involved regulatory and clinical strategy roles at startups and multinational
corporations, 10 years of federal service at the Food and Drug Administration and the National Institute
of Standards and Technology, and a year as an Assistant Professor of Physics at Bucknell. She serves on the
RAPS Editorial Advisory Committee and the Devices Regulatory Affairs Certification Board (RACB)
sub-committee. She holds a PhD in physics from Harvard University.
Yuan Fang, PhD, MBA, PEng, RAC-US
Divisional Vice President,
Global Strategic Regulatory,
Abbott Laboratories Inc.
Yuan Fang, PhD, MBA, PEng, RAC-US, currently serves as Divisional Vice President, Global Strategic
Regulatory at Abbott. Throughout his career, Fang has worked in a variety of regulatory and quality roles in
industry and at the US Food and Drug Administration. He holds a PhD in electrical engineering from the
University of Waterloo (Ontario) and is a licensed professional engineer. He has published more than 30
peer-reviewed journal articles, book chapters, conference proceedings, and holds two US patents.
Medical imaging and radiation therapy are indispensable in healthcare. Medical imaging is central to
the diagnosis, monitoring, and treatment of a variety of clinical conditions in 2016, roughly 700 million
radiologic, computed tomography (CT), dental, and nuclear medicine examinations were performed
in the US.1 Radiation therapy is an important part of cancer treatment, received by over half of cancer
patients as part of their treatment.2 Yet despite the number of lives touched by radiological health and
the critical role that radiological health plays in healthcare, few patients or care providers understand
how these devices actually reach the commercial market in the US – a process in which regulatory affairs
plays a major role. Even regulatory affairs experts coming from other device areas are unlikely to have an
in-depth understanding of regulatory considerations specific to radiological health devices, which deal