What clearance does it need, and where?
Device classification, submissions, and quality systems. Region- and date-specific.
Unsolved engineering problems at this stage, each linked to work documenting the difficulty.
A 510(k) depends on showing equivalence to a legally marketed device, but a headset-delivered therapy or overlay often differs from older products in design, display and software. Choosing a predicate that holds up, and arguing the differences do not change safety or effectiveness, is a recurring hurdle.
Medical XR software runs on consumer-grade headsets whose operating system and firmware change on the platform vendor's schedule. Each change can alter rendering, tracking or timing, and manufacturers must decide what needs re-verification and what a pre-agreed change plan can cover.
The FDA lists cybersecurity and privacy among the probable risks of AR/VR medical devices but sets no headset-specific controls, so each manufacturer has to decide what sensor data to collect and how to protect it.
A plan built from imaging has to be carried into theatre and aligned with the patient on the table, where attention and sterile field both constrain how it can be shown.
Transforms medical imaging into interactive 3D models for surgical planning, rehearsal, patient engagement, and intraoperative XR visualization.
A prescription-use immersive VR system providing adjunctive, skills-based treatment for adults with chronic lower-back pain.
Developer of immersive therapeutics, including the prescription-use RelieVRx system for chronic lower-back pain.
Developer of augmented and mixed reality visualisation for cardiac electrophysiology, including an FDA-cleared platform that renders real-time catheter data as a hands-free 3D hologram.
VR therapy platform delivering structured social and communication practice for neurodiverse learners, delivered on headsets, phones, or a browser.
FDA summary describing RelieVRx, its intended use, device classification, and relationship to the predicate device.