2022
DOI: 10.1007/s10278-022-00622-x
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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’ 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 Evaluati… Show more

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Cited by 41 publications
(26 citation statements)
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“…VR and AR applications in healthcare, medicine, and rehabilitation are revolutionising the way professionals approach patient care; with their ability to provide immersive, interactive, and engaging experiences, these technologies hold the potential to improve patient outcomes and reduce costs, making them an important area for further research and investment. Moreover, they are becoming essential tools in Biomedicine and Bioengineering because of their ability to provide accurate, interactive, and immersive simulations of biological systems [ 88 ]. Thus, these technologies make it possible to deliver home-based assessments and interventions or telehealth, potentially offering cost-effective alternatives in several areas [ 59 , 89 ].…”
Section: Discussionmentioning
confidence: 99%
“…VR and AR applications in healthcare, medicine, and rehabilitation are revolutionising the way professionals approach patient care; with their ability to provide immersive, interactive, and engaging experiences, these technologies hold the potential to improve patient outcomes and reduce costs, making them an important area for further research and investment. Moreover, they are becoming essential tools in Biomedicine and Bioengineering because of their ability to provide accurate, interactive, and immersive simulations of biological systems [ 88 ]. Thus, these technologies make it possible to deliver home-based assessments and interventions or telehealth, potentially offering cost-effective alternatives in several areas [ 59 , 89 ].…”
Section: Discussionmentioning
confidence: 99%
“…The unique display characteristics and more complicated hardware design compared to conventional displays raise significant challenges in regulatory evaluation of VR devices for medical use. 12 Currently, image quality assessments of VR HMDs are primarily based on methods and standards prior developed for conventional FPDs that may not be adequate to describe the image quality in VR. For example, Figure 2 shows that the spatially dependent Michelson contrast measured on a VR HMD using high-spatial-frequency stripe patterns following the IEC standard (IEC 63145-20-20).…”
Section: Introductionmentioning
confidence: 99%
“…The unique display characteristics and more complicated hardware design compared to conventional displays raise significant challenges in regulatory evaluation of VR devices for medical use 12 . Currently, image quality assessments of VR HMDs are primarily based on methods and standards prior developed for conventional FPDs that may not be adequate to describe the image quality in VR.…”
Section: Introductionmentioning
confidence: 99%
“…In the spatial domain, MXR image quality is affected by limited image resolution, optical aberration, luminance nonuniformity, and color shifts. 4 In addition, MXR image perception in an immersive environment are subject to 3D motions of the digital content and human subject. Motion combined with limited display temporal performance can further degrade the MXR image quality in the spatiotemporal domain.…”
Section: Introductionmentioning
confidence: 99%