Augmented and virtual reality (AR/VR) are no longer emerging concepts in healthcare—they're becoming clinical reality. With the release of its AR/VR Medical Device List, the U.S. Food and Drug Administration (FDA) is signalling a strong commitment to fostering innovation in immersive technologies while ensuring patient safety and regulatory clarity. The list, which includes dozens of authorised devices across neurology, orthopaedics, radiology, ophthalmology, and physical medicine, serves as both a milestone and a roadmap for developers of software-driven therapeutics.
From surgical navigation platforms like xvision Spine System to pain management tools such as RelieVRx, the listed devices demonstrate how AR/VR is being leveraged to enhance precision, reduce invasiveness, improve training, and even transform patient rehabilitation. Importantly, each device on the list has met the FDA’s rigorous safety and effectiveness criteria, providing healthcare professionals and patients with validated options for integrating immersive tech into care delivery.
As adoption accelerates, this growing FDA repository not only offers a transparent overview of the current AR/VR MedTech landscape but also encourages the industry to align with regulatory best practices. The list is expected to evolve, with future updates potentially incorporating more sophisticated technologies including foundation models and multimodal AI.
