FDA Outlines Benefits and Risks of Emerging Augmented and Virtual Reality Medical Devices

Thursday, December 8, 2022


Dive Brief:

  • The Food and Drug Administration has published an overview of augmented reality and virtual reality (AR/VR) medical devices. 
  • In the document, the FDA outlines how AR/VR is affecting medical devices, explaining how the technology can deliver certain clinical services, including some typically confined to hospitals and clinics, to patients in their homes. 
  • The FDA sees benefits and risks, noting that AR/VR may increase access to healthcare and make procedures less invasive, but also potentially cause cybersickness and head and neck strain.

Dive Insight:

AR/VR are already changing healthcare. The FDA’s non-exhaustive list of medical devices that incorporate the technology features 39 products across therapeutic areas including orthopedics, ophthalmics, radiology, neurology and cardiovascular.   

Having reviewed and authorized “a growing number of devices” with AR/VR features, the FDA has now set out its thinking on the emerging class of products. The document provides definitions of AR and VR, and then digs into how the technology is impacting medical devices. The FDA sees value in the ability of AR/VR to move care to patients’ homes and 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,” the agency wrote.

The FDA sees potential to use the technology in areas including pediatric diagnostics and treatments, pain management and mental health. Device developers that deploy the technology could deliver a range of benefits, either to all patients with a condition or to subsets of individuals with specific needs. The FDA lists accelerated diagnosis and the mitigation of preoperative anxiety as potential benefits. 

As companies work to deliver those benefits, they will need to be alert to the potential risks of AR/VR. The FDA lists a handful of general probable risks, including cybersecurity and privacy threats, as well as specific concerns related to pediatric populations.

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