In this presentation, we will summarize the landscape of medical devices using augmented and virtual reality technology and discuss the current evaluation gaps and challenges for medical extended reality. In the second part of the presentation, we will give an overview of our recent regulatory science research. Finally, we will present our efforts to develop publicly available regulatory science tools intended to reduce the regulatory burden through standardized methodologies for evaluating safety and effectiveness of medical devices.
Ryan Beams is a Physicist in the Division of Imaging, Diagnostics, and Software Reliability (DIDSR), Office of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health (CDRH), at the U.S. Food and Drug Administration (FDA). He leads the Medical Extended Reality (MXR) program in OSEL. He received a PhD degree in Optics from the University of Rochester in 2013 and a BSc degree in Physics from the Wheaton College in 2005.
Chumin Zhao is a Staff Fellow in the Division of Imaging, Diagnostics, and Software Reliability (DIDSR), Office of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health (CDRH), at the U.S. Food and Drug Administration (FDA). His research involves characterization, modeling, and image quality assessment of medical extended reality devices. He received PhD and MSc degrees in Electrical Engineering from the University of Michigan in 2014 and 2017, respectively, and a BSc degree in Physics from the Hong Kong Baptist University in 2012.
Dr. Miguel Lago is a staff fellow in the Division of Imaging, Diagnostics and Software Reliability at OSEL/CDRH. His research interests involve image quality assessment, both on radiological medical devices (e.g. MRI, CT, mammography) and head mounted displays for AR/VR medical devices. He is interested in developing universal tools for display quality assessment that can be seamlessly deployed to a wide variety of headsets.