
ALT The rapid development of consumer-grade augmented- (AR) and virtual-reality (VR) devices has created interest in leveraging these technologies across a wide range of medical applications including rehabilitation, image-guided surgery, and diagnostics. This presentation will include two parts. ⢠regulatory process This first part will provide an overview of how medical devices are evaluated for benefits and risks and special considerations relevant to AR/VR devices. ⢠regulatory science efforts in AR/VR. The second part of the talk will focus on current regulatory science efforts to address the evaluation gaps in evaluating AR/VR device performance. Speakers Peter J. Yang, Ph.D., RAC De Novo Program Lead, Team Lead, FDA/CDRH/OPEQ/ORP/DRP1/TRP1A Ryan Beams Ph.D. Physicist, US Food & Drug Administration

ALT The rapid development of consumer-grade augmented- (AR) and virtual-reality (VR) devices has created interest in leveraging these technologies across a wide range of medical applications including rehabilitation, image-guided surgery, and diagnostics. This presentation will include two parts. ⢠regulatory process This first part will provide an overview of how medical devices are evaluated for benefits and risks and special considerations relevant to AR/VR devices. ⢠regulatory science efforts in AR/VR. The second part of the talk will focus on current regulatory science efforts to address the evaluation gaps in evaluating AR/VR device performance. Speakers Peter J. Yang, Ph.D., RAC De Novo Program Lead, Team Lead, FDA/CDRH/OPEQ/ORP/DRP1/TRP1A Ryan Beams Ph.D. Physicist, US Food & Drug Administration Moderator Lars Riedemann, M.D. Consulting Neurologist, University Hospital Heidelberg Physician-Scientist, NCT Heidelberg Scientific Director, Shift Medical

ALT The background of space is black. Thousands of galaxies appear all across the view. Their shapes and colors vary. Some are various shades of orange, others are white. Most stars appear blue, and are sometimes as large as more distant galaxies that appear next to them. A very bright star is just above and left of center. It has eight bright blue, long diffraction spikes. Between 4 oāclock and 6 oāclock in its spikes are several very bright galaxies. A group of three are in the middle, and two are closer to 4 oāclock. These galaxies are part of the galaxy cluster SMACS 0723, and they are warping the appearances of galaxies seen around them. Long orange arcs appear at left and right toward the center.































