Evaluation Challenges for the Application of Extended Reality Devices in Medicine

被引：36

作者：

Beams, Ryan ^{[1
]}

Brown, Ellenor ^{[1
]}

Cheng, Wei-Chung ^{[1
]}

Joyner, Janell S. ^{[1
]}

Kim, Andrea S. ^{[1
]}

Kontson, Kimberly ^{[1
]}

Amiras, Dimitri ^{[2
]}

Baeuerle, Tassilo ^{[3
]}

Greenleaf, Walter ^{[4
]}

Grossmann, Rafael J. ^{[5
]}

Gupta, Atul ^{[6
]}

Hamilton, Christoffer ^{[7
]}

Hua, Hong ^{[8
]}

Huynh, Tran Tu ^{[9
]}

Leuze, Christoph ^{[10
]}

Murthi, Sarah B. ^{[11
]}

Penczek, John ^{[12
,13
]}

Silva, Jennifer ^{[14
,15
]}

Spiegel, Brennan ^{[16
]}

Varshney, Amitabh ^{[17
]}

Badano, Aldo ^{[1
]}

机构：

[1] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA

[2] Imperial Coll Healthcare NHS Trust, Dept Imaging, London, England

[3] CognifiSense Inc, Sunnyvale, CA USA

[4] Stanford Univ, Virtual Human Interact Lab, Stanford, CA 94305 USA

[5] Northern Light Hlth, Brewer, ME USA

[6] Philips, Cambridge, MA USA

[7] Brainlab AG, Munich, Germany

[8] Univ Arizona, James C Wyant Coll Opt Sci, Tucson, AZ USA

[9] OpticSurg Inc, Wilmington, DE USA

[10] Stanford Univ, Dept Radiol, Stanford, CA 94305 USA

[11] Univ Maryland Baltimore, R Adams Cowley Shock Trauma Ctr, Baltimore, MD USA

[12] NIST, Boulder, CO USA

[13] Univ Colorado, Boulder, CO 80309 USA

[14] SentiAR Inc, St Louis, MT USA

[15] Washington Univ, Sch Med, Div Pediat Cardiol, St Louis, MO USA

[16] Cedars Sinai Med Ctr, Dept Med, Los Angeles, CA 90048 USA

[17] Univ Maryland, Dept Comp Sci, College Pk, MD 20742 USA

来源：

JOURNAL OF DIGITAL IMAGING | 2022年 / 35卷 / 05期

关键词：

Augmented reality; Virtual reality; Medical imaging; Image quality;

D O I：

10.1007/s10278-022-00622-x

中图分类号：

R8 [特种医学]; R445 [影像诊断学];

学科分类号：

1002 ; 100207 ; 1009 ;

摘要：

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.

引用

页码：1409 / 1418

页数：10

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