@article{6eefc50376964ea7a3c37c766e2063de,
title = "Evaluation Challenges for the Application of Extended Reality Devices in Medicine",
abstract = "Augmented and virtual reality devices are being actively investigated and implemented for a wide range of medical uses. However, significant gaps in the evaluation of these medical devices and applications hinder their regulatory evaluation. Addressing these gaps is critical to demonstrating the devices{\textquoteright} safety and effectiveness. We outline the key technical and clinical evaluation challenges discussed during the US Food and Drug Administration{\textquoteright}s public workshop, “Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine” and future directions for evaluation method development. Evaluation challenges were categorized into several key technical and clinical areas. Finally, we highlight current efforts in the standards communities and illustrate connections between the evaluation challenges and the intended uses of the medical extended reality (MXR) devices. Participants concluded that additional research is needed to assess the safety and effectiveness of MXR devices across the use cases.",
keywords = "Augmented reality, Image quality, Medical imaging, Virtual reality",
author = "Ryan Beams and Ellenor Brown and Cheng, {Wei Chung} and Joyner, {Janell S.} and Kim, {Andrea S.} and Kimberly Kontson and Dimitri Amiras and Tassilo Baeuerle and Walter Greenleaf and Grossmann, {Rafael J.} and Atul Gupta and Christoffer Hamilton and Hong Hua and Huynh, {Tran Tu} and Christoph Leuze and Murthi, {Sarah B.} and John Penczek and Jennifer Silva and Brennan Spiegel and Amitabh Varshney and Aldo Badano",
note = "Funding Information: Janell Joyner is supported by an appointment to the Research Participation Program at the Center for Devices and Radiological Health administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the U.S. Department of Energy and the U.S. Food and Drug Administration. The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services. Publisher Copyright: {\textcopyright} 2022, This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.",
year = "2022",
month = oct,
doi = "10.1007/s10278-022-00622-x",
language = "English",
volume = "35",
pages = "1409--1418",
journal = "Journal of Digital Imaging",
issn = "0897-1889",
number = "5",
}