by John R. Fischer
, Senior Reporter | July 26, 2023
MediView XR has scored its first 510(k) clearance for its XR90 augmented reality-based surgical visualization and navigation platform, which can be used with minimally invasive ultrasound and CT-guided needle-based procedures for soft tissue and bone.
The solution provides physicians with 3D “X-ray vision” to assess patient anatomy under the skin in 3D, including bone, tissue, organs, and the vascular system, which eliminates visualization limitations encountered with conventional 2D flat panel monitors.
“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, in a statement.
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The device incorporates Microsoft’s HoloLens 2 AR headset for visualizing the patient’s ultrasound and other data displays for the procedure, which allows clinicians to concentrate on the surgical site without looking away and potentially disrupting hand-eye coordination.
Using CT scans of the patient’s anatomy, XR90 projects 3D virtual models that are combined with live ultrasound for use in biopsies and tumor ablations. The live ultrasound is projected and displayed anatomically onto the patient as the clinician performs the scan. It also has a Holographic LIght Ray that can track and display the path of the physician’s instruments.
The solution can be used for preoperative planning and to provide better ergonomics for heads-up, intra-operative displays of medical images during ultrasound-guided needle procedures.
It is an adjunctive tool to standard-of-care imaging, and clinicians in remote locations can also use it in real time for shared visualization to provide guidance during procedures. This feature is expected to be an advantage for understaffed providers in rural settings, or with underserved populations, as well as those looking to limit caregiver and patient exposure to COVID-19.
MediView is currently based in Cleveland and distributes these technologies through partnerships it has with GE HealthCare and Microsoft.