Augmented Reality and Virtual Reality in Medical Devices
September 6, 2024 update: The U.S. Food and Administration updated the list of medical devices that incorporate AR/VR. With this update, the FDA has authorized 69 medical devices that incorporate Augment Reality (AR) and Virtual Reality (VR).
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?
- How Are Augmented Reality and Virtual Reality Impacting Medical Devices?
- Augmented Reality and Virtual Reality Medical Devices: Questions to Consider
- List of Medical Devices that Incorporate Augmented Reality and Virtual Reality
- FDA Resources
- Contact Us
What Is Augmented Reality and Virtual Reality?
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.
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?
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.
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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 AR/VR. Rather, it is a list of medical devices that incorporate AR/VR 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.
*To save the XML file, right click and save the file to your computer and open in the appropriate program
| Date of Final Decision | Submission Number | Device | Company | Panel (lead) | Primary Product Code |
|---|---|---|---|---|---|
| 12/20/2019 | K190929 | xvision Spine system (XVS) | Augmedics Ltd. | Orthopedic | OLO |
| 12/05/2023 | K233568 | Ceevra Reveal 3+ | Ceevra, Inc. | Radiology | QIH |
| 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 |
| 11/25/2022 | K213215 | VSI HoloMedicine | ApoQlar GmbH | Radiology | LLZ |
| 11/17/2022 | K220905 | xvision Spine System | Augmedics Ltd. | Orthopedic | OLO |
| 11/16/2021 | DEN210014 | EaseVRx | AppliedVR, Inc. | Physical Medicine | QRA |
| 11/10/2021 | K210344 | inVisionOS | PrecisionOS Technology Inc. | Radiology | LLZ |
| 11/05/2021 | K210859 | NextAR Spine Platform | Medacta International, SA | Orthopedic | OLO |
| 11/04/2022 | K221659 | Luminopia One | Luminopia, Inc. | Ophthalmic | QQU |
| 11/02/2023 | K232176 | STELLAR Knee | PolarisAR Inc. | Orthopedic | OLO |
| 10/31/2023 | K230814 | VRNT | CognifiSense, Inc. | Physical Medicine | QRA |
| 10/29/2023 | K232280 | NextAR TSA Platform | Medacta International S.A. | Orthopedic | OLO |
| 10/27/2020 | K202152 | NextAR TKA Platform | Medacta International SA | Orthopedic | OLO |
| 10/21/2022 | K213128 | IntraOp VSP Software Device | Xironetic, LLC | Radiology | LLZ |
| 10/20/2021 | DEN210005 | Luminopia One | Luminopia, Inc. | Ophthalmic | QQU |
| 10/16/2023 | K230249 | Ikshana | ImmersiveTouch | Radiology | LLZ |
| 10/02/2021 | K202927 | EYE-SYNC | SyncThink, Inc. | Neurology | QEA |
| 09/29/2022 | K213034 | SpineAR SNAP | Surgical Theater, Inc. | Orthopedic | OLO |
| 09/29/2021 | K210726 | ImmersiveTouch | ImmersiveTouch, Inc. | Radiology | LLZ |
| 09/25/2023 | K230825 | Smileyscope System (Therapy Mode) | Smileyscope Holding Inc. | Physical Medicine | QRA |
| 09/21/2018 | K172418 | OpenSight | Novarad Corporation | Radiology | LLZ |
| 09/18/2020 | K192890 | SentEP | SentiAR, Inc | Cardiovascular | LLZ |
| 09/14/2023 | K232189 | OrionXR | Hoth Intelligence Inc. | Radiology | LLZ |
| 09/08/2023 | K231284 | OnPoint Augmented Reality Spine System | OnPoint Surgical, Inc. | Orthopedic | OLO |
| 09/01/2022 | K220104 | Knee+ | Pixee Medical | Orthopedic | OLO |
| 08/31/2023 | K231611 | HOLO Portal Surgical Guidance System | Surgalign Spine Technologies | Orthopedic | OLO |
| 08/29/2019 | K183489 | D2P | 3D Systems, Inc. | Radiology | LLZ |
| 08/03/2017 | K171356 | Clarity Reveal | Ceevra, Inc. | Radiology | LLZ |
| 07/29/2022 | K220733 | OptiVu ROSA MxR | Orthosoft, Inc. (d/b/a Zimmer CAS) | Orthopedic | OLO |
| 07/21/2023 | K223769 | NextAR Spine Platform | Medacta International S.A. | Orthopedic | OLO |
| 07/19/2021 | K211188 | xvision Spine system (XVS) | Augmedics Ltd | Orthopedic | OLO |
| 07/17/2020 | K201465 | SuRgical Planner (SRP) BrainStorm | Surgical Theater, Inc. | Radiology | LLZ |
| 07/14/2023 | K223290 | CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) | SentiAR, Inc. | Cardiovascular | LLZ |
| 07/14/2021 | K203115 | ARVIS Surgical Navigation System | Insight Medical Systems Inc. | Orthopedic | OLO |
| 07/13/2023 | K223125 | XR90 (XR90-SYS) | MediView XR, Inc. | Radiology | LLZ |
| 07/12/2022 | K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit | Stryker Corporation | Ear, Nose, & Throat | PGW |
| 07/10/2020 | K193559 | NextAR TKA Platform | Medacta Inernational SA | Orthopedic | PBF |
| 06/28/2016 | K160584 | Surgical Navigation Advanced Platform (SNAP) | SURGICAL THEATER, LLC | Radiology | LLZ |
| 06/15/2022 | K213684 | SurgiCase Viewer | Materialise NV | Radiology | LLZ |
| 06/13/2024 | K232930 | VERVE | OculoMotor Technologies | Ophthalmic | SBN |
| 06/13/2023 | K230567 | OptiVu ROSA® MxR | Orthosoft Inc. (d/b/a Zimmer CAS) | Orthopedic | OLO |
| 05/27/2022 | K220146 | VisAR | Novarad Corporation | Orthopedic | OLO |
| 05/24/2023 | K222035 | Avatar Medical Software V1 | Avatar Medical | Radiology | LLZ |
| 05/21/2024 | K232759 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | Brainlab AG | Radiology | LLZ |
| 05/14/2021 | K210072 | HOLOSCOPE-i | Real View Imaging Ltd. | Radiology | LLZ |
| 05/13/2019 | K190764 | SurgicalAR | MEDIVIS, Inc. | Radiology | LLZ |
| 05/12/2021 | K210153 | NextAR RSA Platform | Medacta International SA | Orthopedic | OLO |
| 05/01/2023 | K221870 | CarnaLife Holo | MedApp S.A. | Radiology | LLZ |
| 04/25/2023 | K222676 | Ceevra Reveal 3 | Ceevra, Inc. | Radiology | QIH |
| 04/24/2024 | K233172 | NextAR Spine Platform | Medacta International S.A. | Orthopedic | OLO |
| 04/24/2017 | K162748 | MindMotionPRO | MindMaze SA | Physical Medicine | LXJ |
| 04/21/2023 | K230789 | Knee+ | Pixee Medical | Orthopedic | OLO |
| 04/21/2021 | K202750 | Knee+ | Pixee Medical | Orthopedic | OLO |
| 03/25/2024 | K240620 | Cube Navigator | Medical Templates AG | Radiology | LLZ |
| 03/18/2019 | K183296 | REAL Immersive System | Penumbra, Inc. | Physical Medicine | ISD |
| 03/10/2022 | K213751 | NextAR TKA Platform My Knee PPS | Medacta International S.A. | Orthopedic | OLO |
| 03/08/2024 | K233899 | Knee+ | Pixee Medical | Orthopedic | OLO |
| 02/24/2023 | K222757 | Clarus Viewer | Clarus Viewer Corporation | Radiology | LLZ |
| 02/22/2019 | K182643 | IRIS 1.0 System | Intuitive Surgical | Radiology | LLZ |
| 02/14/2019 | K190074 | Presero 3D Scanning System | Certis Health | General & Plastic Surgery | LLZ |
| 02/12/2018 | K170793 | SuRgical Planner (SRP) | Surgical Theater, LLC | Radiology | LLZ |
| 02/12/2016 | K153004 | Clear Guide SCENERGY | CLEAR GUIDE MEDICAL | Radiology | JAK |
| 02/05/2016 | K151955 | YuGo System | BIOGAMING LTD. | Physical Medicine | LXJ |
| 02/01/2024 | K232339 | Augmented Reality Application | Sira Medical, Inc. | Radiology | LLZ |
| 01/29/2016 | K152915 | EYE-SYNC | SyncThink, Inc. | Neurology | GWN |
| 01/28/2021 | K200384 | HipXpert 3D Display and Anchoring Application | Surgical Planning Associates, Inc | Orthopedic | OSF |
| 01/23/2020 | K191014 | Elements Viewer | Brainlab AG | Radiology | LLZ |
| 01/21/2015 | K142107 | ECHO TRUE 3D VIEWER | ECHO PIXEL INC. | Radiology | LLZ |
| 01/14/2022 | K211254 | ARAI Surgical Navigation System | Surgalign Spine Technologies | Orthopedic | OLO |
FDA Resources
- FDA Medical Extended Reality Program
- Patient Engagement and Advisory Committee Meeting on Augmented Reality and Virtual Reality Medical Devices: July 12-13, 2022
- Medical Device Reporting (MDR): How to Report Medical Device Problems
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.