FDA issue statement on virtual reality medical devices

by | Jan 11, 2023

Healthcare has already been altered by AR and VR. 39 products are included on the FDA’s non-exhaustive list of medical devices that use the technology, which spans a number of therapeutic fields such as orthopedics, ophthalmology, radiography, neurology, and cardiovascular.

The FDA has officially stated its position on the new class of gadgets after reviewing and approving an increasing number of devices with AR/VR functionality. The article defines augmented reality (AR) and virtual reality (VR) before delving into how the technologies are affecting medical devices. The FDA recognizes the value of using AR and VR to deliver treatment outside of traditional clinical settings, such as patients’ homes.

The FDA anticipates applications for the technology in pediatric diagnosis and care, pain management, and mental health. The technology’s adoption by device manufacturers has the potential to serve a variety of patients with a condition or groups of people with particular needs. Accelerated diagnosis and the reduction of preoperative anxiety are two potential advantages listed by the FDA.

The corporation commented on this, explaining ‘“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,”

Companies will need to be aware of the possible risks of AR/VR as they try to offer those benefits. The FDA mentions a few broad potential dangers, such as threats to cybersecurity and personal information, as well as particular worries regarding juvenile populations.

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