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?
• 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.

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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