Evaluation Challenges for the Application of Extended Reality Devices in Medicine

Ryan Beams, Ellenor Brown, Wei Chung Cheng, Janell S. Joyner, Andrea S. Kim, Kimberly Kontson, Dimitri Amiras, Tassilo Baeuerle, Walter Greenleaf, Rafael J. Grossmann, Atul Gupta, Christoffer Hamilton, Hong Hua, Tran Tu Huynh, Christoph Leuze, Sarah B. Murthi, John Penczek, Jennifer Silva, Brennan Spiegel, Amitabh VarshneyAldo Badano

Research output: Contribution to journalArticlepeer-review

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’ safety and effectiveness. We outline the key technical and clinical evaluation challenges discussed during the US Food and Drug Administration’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.

Original languageEnglish
JournalJournal of Digital Imaging
DOIs
StateAccepted/In press - 2022

Keywords

  • Augmented reality
  • Image quality
  • Medical imaging
  • Virtual reality

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