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?
- How Are Augmented Reality and Virtual Reality Impacting Medical Devices?
- List of Medical Devices that Incorporate Augmented Reality and Virtual Reality
- Augmented Reality and Virtual Reality News and Updates
- 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 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?
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
- Patient Engagement and Advisory Committee Meeting on Augmented Reality and Virtual Reality Medical Devices: July 12-13, 2022
- Augmented Reality and Virtual Reality Medical Devices: Questions to Consider
FDA Resources
- FDA Medical Extended Reality Program
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
- Multiple Function Device Products: Policy and Considerations
- Applying Human Factors and Usability Engineering to Medical Devices
- Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions
- Premarket Notification 510(k)
- De Novo Classification Request
- Premarket Approval (PMA)
- 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.