The U.S. Food and Drug Administration (FDA) has updated its list of authorized medical devices that incorporate augmented reality (AR) and virtual reality (VR) technologies.
The FDA’s list now includes 69 different AR- or VR-augmented devices that have been authorized by the agency through its 510(k), De Novo, or Premarket Approval processes. The authorized devices include a variety of technologies applicable for used in many different fields of medicine, including orthopedics, radiology, ophthalmology, cardiology, and others.
The FDA says that AR and VR “have the potential to transform healthcare, delivering new types of treatments and diagnostics and changing how and where care is delivered.” Examples of AR include the ability to mix digital imagery with the real world (mixed or merged reality), while examples of VR include devices that project medical images onto a patient during an operating procedure to help guide the surgeon.
The FDA’s updated list of authorized medical devices that incorporate AR and VR is available at https://www.fda.gov/medical-devices/digital-health-center-excellence/augmented-reality-and-virtual-reality-medical-devices#list.
