A Comprehensive Review of Food and Drug Administration (FDA)-Cleared Virtual Reality Technologies in Radiology

TL;DR

This paper reviews FDA-cleared virtual reality systems used in radiology to improve 3D imaging interpretation and clinical workflows.

Contribution

The study provides a focused review of seven FDA-cleared VR systems specifically relevant to radiology, highlighting their clinical applications and challenges.

Findings

Seven FDA-cleared VR systems are directly applicable to radiology, enabling 3D visualization and manipulation of imaging data.

These systems aim to enhance diagnostic precision, procedural planning, and interdisciplinary collaboration in radiology.

Regulatory documentation and peer-reviewed evaluations indicate growing potential for VR in reshaping radiology practices.

Abstract

Virtual reality (VR) is emerging as a clinically relevant tool in diagnostic radiology, offering immersive environments for image interpretation, medical education, and preoperative planning. Despite the field’s continued reliance on two-dimensional (2D) monitors to assess inherently three-dimensional (3D) imaging data, immersive technologies remain underutilized in clinical workflows. As of 2024, the U.S. Food and Drug Administration (FDA) has cleared 69 devices categorized under virtual and augmented reality. This review focuses on the seven VR systems with direct applications in radiology: Ceevra Reveal 3+ (Ceevra, Inc., San Francisco, CA, USA), VSI HoloMedicine (apoQlar medical GmbH, Hamburg, Germany), Dextroscope (Volume Interactions Pte Ltd, Singapore), Dextrobeam (Volume Interactions), V3D-Colon (Viatronix, Inc., Stony Brook, NY, USA), V3D-Explorer (Viatronix), and V3D-Vascular (Viatronix). These platforms enable users to visualize, manipulate, and interpret radiological data in fully immersive 3D space, enhancing diagnostic precision, procedural planning, and interdisciplinary collaboration. Drawing on regulatory documentation and peer-reviewed evaluations, this article assesses the clinical functions, implementation challenges, and future potential of these technologies. As immersive tools gain regulatory momentum and technical refinement, VR is positioned to expand radiology’s diagnostic capabilities and reshape its educational and clinical landscape.