U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Digital Health Center of Excellence
  4. Augmented Reality and Virtual Reality in Medical Devices
  1. Digital Health Center of Excellence

Augmented Reality and Virtual Reality in Medical Devices

UPDATE: September 1, 2023:

Augmented Reality and Virtual Reality Medical Devices: Questions to Consider

If you’re a patient, caregiver, or health care professional considering using AR/VR in your health care or practice, the U.S. Food and Drug Administration developed these infographics to help you make an informed decision. 

Augmented Reality and Virtual Reality (AR/VR) have the potential to transform health care, delivering altogether new types of treatments and diagnostics, and changing how and where care is delivered. Central to their potential in diagnosis and treatment is their ability to deliver both standard and entirely new types of content in highly immersive and realistic ways, remotely, and tailored to a variety of clinical contexts. Physicians, patients, and caregivers can enlist AR/VR to help them prepare for, or perform, certain treatments or procedures.

On this page:

What Is Augmented Reality and Virtual Reality?

A surgeon wearing blue scrubs and using a virtual reality headset to operate on an individual. He is aided by two nurses wearing blue scrubs.

Augmented Reality (AR) is a real-world augmented experience with overlaying or mixing simulated digital imagery with the real world as seen through a camera or display, such as a smartphone or head-mounted or heads-up display (HUD). Digital imagery may be able to interact with real surroundings (often controlled by users). This is sometimes referred to as mixed or merged reality.

Virtual Reality (VR) is a virtual world immersive experience that may require a headset to completely replace a user’s surrounding view with a simulated, immersive, and interactive virtual environment.

A girl sits down with her hands up and wears a virtual reality headset.

The term extended reality, or augmented reality and virtual reality, is often enlisted to encompass the two approaches, but for the purposes of this web page, we will use the terms augmented reality and virtual reality.

Some real-world examples of augmented reality and virtual reality applications already being used to treat patients include:

  • An AR system that overlays medical images onto a patient during an operation to help guide the surgeon’s technique.
  • A VR system that is used to treat post-traumatic stress disorder in army veterans.
  • A VR rehabilitation therapy that simulates real-life situations to improve physical functions for patients who have experienced a physical disability associated with a stroke or other medical condition.

How Are Augmented Reality and Virtual Reality Impacting Medical Devices?

Adjusting a virtual readlity headset

Image Courtesy of VA.gov

AR/VR can deliver some types of clinical services—including some normally delivered only in clinics and hospitals—to patients in their homes or other non-clinical settings. This could enable patients, including the socioeconomically vulnerable and underserved communities, the elderly or disabled, to access needed health care services when accessing them in person would otherwise be difficult, and this could make it easier, and more likely, for patients to complete treatment and monitoring regimens. 

There are a number of treatment domains in which augmented reality and virtual reality are used to treat patients. Among those domains are:

  • Pediatric diagnostics and treatments
  • Pain management
  • Mental health
  • Neurological disorders
  • Surgery planning
  • Intraoperative procedures
  • Ophthalmic diagnostics
  • Telemedicine
  • Virtual Care
  • Post operative and other rehabilitation therapies

Relative to current therapies, an AR/VR device may introduce new benefits and novel approaches. Such benefits may be identified across a wide variety of patients, or it may be more beneficial for some patients than others. A device may demonstrate particular benefit for underserved populations (for example, patients with more limited access to medical care) or vulnerable populations (for example, children, patients with mental health or cognitive impairment). However, an AR/VR device may have risks as well, including risks related to the usability of the device (such as neck pain from the weight of the headset), and risks related to the content and images that the AR/VR technologies provide (such as low contrast images, display errors such as location or depth of anatomy, information overload, dizziness, fatigue, or effects on vision).

  • Examples of probable benefits:
    • Increase access to necessary health care when accessing in person would be difficult
    • Improve health care professional's ability to prepare for certain treatments
    • Fulfill unmet medical needs
    • Mitigate preoperative anxiety
    • Make procedures less invasive
    • Accelerate diagnoses
    • Allow for self-directed care
  • Examples of probable risks:
    • Cybersickness
    • Head and neck strain
    • Cybersecurity risks
    • Privacy risks
    • Distraction in the operating room
  • Effects of AR/VR on populations
    • Unknown side effects and/or risks (particularly in pediatrics or other vulnerable populations)
    • Potentially worsening disparities in diagnostics and treatment

List of Medical Devices that Incorporate Augmented Reality and Virtual Reality

The FDA has reviewed and authorized for marketing a growing number of devices through 510(k) clearance, granted De Novo request, or Premarket Approval with AR/VR across many different fields of medicine—and expects this trend to continue.

The FDA is providing this list of medical devices that incorporate AR/VR marketed in the United States as a resource to the public about these devices and the FDA’s work in this area.

Contents of this list:

The FDA assembled this list by searching FDA’s publicly facing information. The list is not meant to be an exhaustive or comprehensive resource of medical devices that incorporate Augmented Reality and Virtual Reality. Rather, it is a list of medical devices that incorporate A/R and V/R across medical disciplines based on information provided in the summary descriptions of their marketing authorization document.

Updates to this list: The FDA plans to update this list on a periodic basis. 

Date of Final Decision Submission Number Device Company Panel (Lead) Primary Product Code
01/21/2015 K142107 ECHO TRUE 3D VIEWER ECHO PIXEL INC. Radiology LLZ
01/29/2016 K152915 EYE-SYNC SyncThink, Inc. Neurology GWN
02/05/2016 K151955 YuGo System BIOGAMING LTD. Physical Medicine LXJ
02/12/2016 K153004 Clear Guide SCENERGY CLEAR GUIDE MEDICAL Radiology JAK
06/28/2016 K160584 Surgical Navigation Advanced Platform (SNAP) SURGICAL THEATER, LLC Radiology LLZ
04/24/2017 K162748 MindMotionPRO MindMaze SA Physical Medicine LXJ
02/12/2018 K170793 SuRgical Planner (SRP) Surgical Theater, LLC Radiology LLZ
09/21/2018 K172418 OpenSight Novarad Corporation Radiology LLZ
02/22/2019 K182643 IRIS 1.0 System Intuitive Surgical Radiology LLZ
03/18/2019 K183296 REAL Immersive System Penumbra, Inc. Physical Medicine ISD
05/13/2019 K190764 SurgicalAR MEDIVIS, Inc. Radiology LLZ
08/29/2019 K183489 D2P 3D Systems, Inc. Radiology LLZ
11/29/2019 K192186 I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph Neurolign USA, LLC Ear, Nose, & Throat GWN
12/20/2019 K190929 xvision Spine system (XVS) Augmedics Ltd. Orthopedic OLO
01/23/2020 K191014 Elements Viewer Brainlab AG Radiology LLZ
07/10/2020 K193559 NextAR TKA Platform Medacta Inernational SA Orthopedic OLO
07/17/2020 K201465 SuRgical Planner (SRP) BrainStorm Surgical Theater, Inc. Radiology LLZ
09/18/2020 K192890 SentEP SentiAR, Inc Cardiovascular LLZ
10/27/2020 K202152 NextAR TKA Platform Medacta International SA Orthopedic OLO
01/28/2021 K200384 HipXpert 3D Display and Anchoring Application Surgical Planning Associates, Inc Orthopedic OSF
04/21/2021 K202750 Knee+ Pixee Medical Orthopedic OLO
05/12/2021 K210153 NextAR RSA Platform Medacta International SA Orthopedic OLO
05/14/2021 K210072 HOLOSCOPE-i Real View Imaging Ltd. Radiology LLZ
07/14/2021 K203115 ARVIS Surgical Navigation System Insight Medical Systems Inc. Orthopedic OLO
07/19/2021 K211188 xvision Spine system (XVS) Augmedics Ltd Orthopedic OLO
09/29/2021 K210726 ImmersiveTouch ImmersiveTouch, Inc. Radiology LLZ
10/02/2021 K202927 EYE-SYNC SyncThink, Inc. Neurology QEA
10/20/2021 DEN210005 Luminopia One Luminopia, Inc. Ophthalmic QQU
11/05/2021 K210859 NextAR Spine Platform Medacta International, SA Orthopedic OLO
11/10/2021 K210344 inVisionOS PrecisionOS Technology Inc. Radiology LLZ
11/16/2021 DEN210014 EaseVRx AppliedVR, Inc. Physical Medicine QRA
01/14/2022 K211254 ARAI Surgical Navigation System Surgalign Spine Technologies Orthopedic OLO
03/10/2022 K213751 NextAR TKA Platform My Knee PPS Medacta International S.A. Orthopedic OLO
05/27/2022 K220146 VisAR Novarad Corporation Orthopedic OLO
06/15/2022 K213684 SurgiCase Viewer Materialise NV Radiology LLZ
07/29/2022 K220733 OptiVu ROSA MxR Orthosoft, Inc. (d/b/a Zimmer CAS) Orthopedic OLO
09/01/2022 K220104 Knee+ Pixee Medical Orthopedic OLO
09/29/2022 K213034 SpineAR SNAP Surgical Theater, Inc. Orthopedic OLO

Augmented Reality and Virtual Reality News and Updates

FDA Resources

Contact Us

If you have questions about augmented reality, virtual reality, or other digital health topics, please visit Ask a Question About Digital Health Regulatory Policies.

Back to Top