FDA clears MediView augmented reality visualization, navigation platform

The XR90 surgical visualization and navigation platform. [Image courtesy of MediView]MediView XR announced today that it received FDA 510(k) clearance for its XR90 augmented reality-based visualization and navigation platform.

The company designed the surgical platform for adjunctive use in minimally invasive ultrasound and CT-guided needle-based procedures. Cleveland-based MediView said in a news release that its uses include procedures for soft tissue and bone.

“This is not only the first 510(k) clearance for MediView, but it is the first 510(k) clearance for an augmented reality device utilizing live imaging combined with 3D XR visualization for pre- and intra-operative indications for use, which sets the stage for further advancements in augmented reality in the healthcare space.” said Adam Cargill, director of quality, regulatory and clinical affairs at MediView.

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