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Augmented Reality and Virtual Reality in Medical Devices

Augmented Reality and Virtual Reality have the potential to transform health care, delivering 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 AR/VR 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

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

However, an AR/VR device may have risks, including risks related to using 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

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 (FDA) has developed these infographics to help you make an informed decision.

Thumbnail of infographic for Augmented Reality and Virtual Reality in Medical Devices
Thumbnail of infographic for Augmented Reality and Virtual Reality in Medical Devices for Providers

View the Infographics

List of Medical Devices that Incorporate Augmented Reality and Virtual Reality

The FDA encourages the development of innovative, safe, and effective medical devices, including devices that incorporate augmented reality and virtual reality (AR/VR).

The AR/VR Medical Device List is a resource intended to identify AR/VR medical devices that are authorized for marketing in the United States. Digital health innovators can refer to this list to gain insights into the current market landscape and regulatory expectations, which can help foster innovation and ensure public safety. This list can also provide transparency to healthcare providers and patients to clearly identify when medical devices use AR/VR technologies.

Contents of the AR/VR Medical Devices List:

  • The devices in this list have met the FDA’s applicable premarket requirements, including a focused review of the device’s overall safety and effectiveness, which includes an evaluation of study appropriateness for the device’s intended use and technological characteristics.
  • A direct link to the FDA’s database entry of an AR/VR medical device is provided. The database entry contains releasable information, such as summaries of safety and effectiveness. Note, the summaries are not all inclusive and do not include most of the information that may be included in a submission.
  • The list is not a comprehensive resource of AR/VR medical devices. Instead, the list includes AR/VR medical devices that were identified primarily based on information provided in the summary descriptions of their marketing authorization document.

This list will continue to be updated periodically. AR/VR medical devices that received authorization but for which decision summaries have not been published within the data collection period will be incorporated into a subsequent update.

Send questions or feedback on this list to digitalhealth@fda.hhs.gov.

AR/VR Medical Devices List

Devices are listed in reverse chronological order by Date of Final Decision. To change the sort order, click the arrows in the column headings.

Use the Submission Number link to display the approval, authorization, or clearance information for the device in the appropriate FDA database. The database page will include a link to the FDA's publicly available information.

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*To save the XML file, right click and save the file to your computer and open in the appropriate program 

Date of Final DecisionSubmission NumberDevice CompanyPanel (lead)Primary Product Code
05/16/2025K242569Mixed Reality Spine NavigationBrainlab AGNeurologySBF
05/02/2025K243069LUMYS (V1)INTRADYSRadiologyLLZ
03/21/2025K243980ARVIS Surgical Navigation SystemKico Knee Innovation Company Pty LimitedNeurologySBF
03/20/2025K243975Knee+Pixee MedicalNeurologySBF
03/13/2025K250255xvision Spine systemAugmedics Ltd.NeurologySBF
01/14/2025K242205SpectoMed (v1.0)Specto MedicalRadiologyLLZ
01/13/2025K243950ARVIS® ShoulderKico Knee Innovation Company Pty LtdNeurologySBF
12/24/2024K243623SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.NeurologySBF
12/04/2024K243417RelieVRxAppliedVRNeurologyQRA
10/30/2024K242271Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.NeurologySBF
10/21/2024K242058Digital Prism Correction Feature (DPCF)Apple Inc.OphthalmicSCW
10/16/2024K241481xvision Spine SystemAugmedics Ltd.NeurologySBF
09/10/2024K240094LumiNE US; LumiAugmedit B.V.RadiologyQIH
08/19/2024K241870OnPoint Augmented Reality Spine SystemOnPoint Surgical, Inc.NeurologySBF
08/08/2024K233315HipXpert and HipInsight SystemSurgical Planning Associates, IncNeurologyOSF
07/26/2024K233725Spine Navigation SystemMedivis, Inc.NeurologyOLO
06/13/2024K232930VERVEOculoMotor TechnologiesOphthalmicSBN
05/21/2024K232759Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart LayoutBrainlab AGRadiologyLLZ
04/24/2024K233172NextAR Spine PlatformMedacta International S.A.OrthopedicOLO
03/25/2024K240620Cube NavigatorMedical Templates AGRadiologyLLZ
03/08/2024K230195Neo ADVISE softwareComerge AGNeurologyOLO
03/08/2024K233899Knee+Pixee MedicalOrthopedicOLO
02/01/2024K232339Augmented Reality ApplicationSira Medical, Inc.RadiologyLLZ
12/05/2023K233568Ceevra Reveal 3+Ceevra, Inc.RadiologyQIH
11/02/2023K232176STELLAR KneePolarisAR Inc.OrthopedicOLO
10/31/2023K230814VRNTCognifiSense, Inc.Physical MedicineQRA
10/29/2023K232280NextAR TSA PlatformMedacta International S.A.OrthopedicOLO
10/16/2023K230249IkshanaImmersiveTouch, Inc.RadiologyLLZ
09/25/2023K230825Smileyscope System (Therapy Mode)Smileyscope Holding Inc.Physical MedicineQRA
09/14/2023K232189OrionXRHoth Intelligence Inc.RadiologyLLZ
09/08/2023K231284OnPoint Augmented Reality Spine SystemOnPoint Surgical, Inc.OrthopedicOLO
08/31/2023K231611HOLO Portal Surgical Guidance SystemSurgalign Spine TechnologiesOrthopedicOLO
07/21/2023K223769NextAR Spine PlatformMedacta International S.A.OrthopedicOLO
07/14/2023K223290CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)SentiAR, Inc.CardiovascularLLZ
07/13/2023K223125XR90 (XR90-SYS)MediView XR, Inc.RadiologyLLZ
06/13/2023K230567OptiVu ROSA® MxROrthosoft, Inc. (d/b/a Zimmer CAS)OrthopedicOLO
05/24/2023K222035Avatar Medical Software V1Avatar MedicalRadiologyLLZ
05/01/2023K221870CarnaLife HoloMedApp S.A.RadiologyLLZ
04/25/2023K222676Ceevra Reveal 3Ceevra, Inc.RadiologyQIH
04/21/2023K230789Knee+Pixee MedicalOrthopedicOLO
02/24/2023K222757Clarus ViewerClarus Viewer CorporationRadiologyLLZ
01/20/2023K222510Blueprint Mixed Reality systemTornier SASNeurologyOLO
12/30/2022K221796Cyware 4H and Cysart 4HAbys MedicalRadiologyLLZ
12/16/2022K220554Caduceus STaiwan Main Orthopaedic Biotechnology Co., Ltd.NeurologyOLO
11/25/2022K213215VSI HoloMedicineApoQlar GmbHRadiologyLLZ
11/17/2022K220905xvision Spine SystemAugmedics Ltd.OrthopedicOLO
11/04/2022K221659Luminopia OneLuminopia, Inc.OphthalmicQQU
10/21/2022K213128IntraOp VSP Software DeviceXironetic, LLCRadiologyLLZ
09/29/2022K213034SpineAR SNAPSurgical Theater, Inc.OrthopedicOLO
09/01/2022K220104Knee+Pixee MedicalOrthopedicOLO
07/29/2022K220733OptiVu ROSA MxROrthosoft, Inc. (d/b/a Zimmer CAS)OrthopedicOLO
07/12/2022K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation UnitStryker CorporationEar, Nose, & ThroatPGW
06/15/2022K213684SurgiCase ViewerMaterialise NVRadiologyLLZ
05/27/2022K220146VisARNovarad CorporationOrthopedicOLO
03/10/2022K213751NextAR TKA Platform My Knee PPSMedacta International S.A.OrthopedicOLO
01/14/2022K211254ARAI Surgical Navigation SystemSurgalign Spine TechnologiesOrthopedicOLO
11/16/2021DEN210014EaseVRxAppliedVR, Inc.Physical MedicineQRA
11/10/2021K210344inVisionOSPrecisionOS Technology Inc.RadiologyLLZ
11/05/2021K210859NextAR Spine PlatformMedacta International S.A.OrthopedicOLO
10/20/2021DEN210005Luminopia OneLuminopia, Inc.OphthalmicQQU
10/02/2021K202927EYE-SYNCSyncThink, Inc.NeurologyQEA
09/29/2021K210726ImmersiveTouchImmersiveTouch, Inc.RadiologyLLZ
07/19/2021K211188xvision Spine system (XVS)Augmedics Ltd.OrthopedicOLO
07/14/2021K203115ARVIS Surgical Navigation SystemInsight Medical Systems Inc.OrthopedicOLO
05/14/2021K210072HOLOSCOPE-iReal View Imaging Ltd.RadiologyLLZ
05/12/2021K210153NextAR RSA PlatformMedacta International S.A.OrthopedicOLO
04/21/2021K202750Knee+Pixee MedicalOrthopedicOLO
01/28/2021K200384HipXpert 3D Display and Anchoring ApplicationSurgical Planning Associates, IncOrthopedicOSF
10/27/2020K202152NextAR TKA PlatformMedacta International S.A.OrthopedicOLO
09/18/2020K192890SentEPSentiAR, Inc.CardiovascularLLZ
07/17/2020K201465SuRgical Planner (SRP) BrainStormSurgical Theater, Inc.RadiologyLLZ
07/10/2020K193559NextAR TKA PlatformMedacta International S.A.OrthopedicPBF
01/23/2020K191014Elements ViewerBrainlab AGRadiologyLLZ
12/20/2019K190929xvision Spine system (XVS)Augmedics Ltd.OrthopedicOLO
11/29/2019K192186I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - NysragmographNeurolign USA, LLCEar, Nose, & ThroatGWN
08/29/2019K183489D2P3D Systems, Inc.RadiologyLLZ
05/13/2019K190764SurgicalARMedivis, Inc.RadiologyLLZ
03/18/2019K183296REAL Immersive SystemPenumbra, Inc.Physical MedicineISD
02/22/2019K182643IRIS 1.0 SystemIntuitive SurgicalRadiologyLLZ
02/14/2019K190074Presero 3D Scanning SystemCertis HealthGeneral & Plastic SurgeryLLZ
09/21/2018K172418OpenSightNovarad CorporationRadiologyLLZ
07/10/2018K173274Ceevra Reveal 2.0Ceevra, Inc.RadiologyLLZ
02/12/2018K170793SuRgical Planner (SRP)Surgical Theater, LLCRadiologyLLZ
08/03/2017K171356Clarity RevealCeevra, Inc.RadiologyLLZ
04/24/2017K162748MindMotionPROMindMaze SAPhysical MedicineLXJ
03/03/2017K170167True 3D Viewer SoftwareEchoPixel Inc.RadiologyLLZ
02/28/2017K163245Virtual Occupational Therapy Application (VOTA)Barron Associates, Inc.Physical MedicineLXJ
06/28/2016K160584Surgical Navigation Advanced Platform (SNAP)Surgical Theater, LLCRadiologyLLZ
02/12/2016K153004Clear Guide SCENERGYClear Guide MedicalRadiologyJAK
02/05/2016K151955YuGo SystemBioGaming LTD.Physical MedicineLXJ
01/29/2016K152915EYE-SYNCSyncThink, Inc.NeurologyGWN
01/21/2015K142107ECHO TRUE 3D VIEWEREchoPixel, Inc.RadiologyLLZ

FDA Resources

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