Augmented reality company MediView XR, Inc.. announces that it has received U.S. FDA 510(k) clearance for its XR90 augmented reality-based surgical visualization and navigation platform. XR90 is intended to be used adjunctively for minimally invasive ultrasound and CT-guided needle-based 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,” says Adam Cargill, director of quality, regulatory and clinical affairs at MediView.

Mina Fahim, MediView’s president and CEO, also spoke out about the clearance, adding: “XR90 expands the MediView portfolio of solutions available to practitioners as they look to simplify, democratize, and inform care delivery with the ultimate goal of improving and expanding access to the best care. Thank you to our employees, investors, and partners for making this possible. We are just at the beginning of a journey seeing the clinical adoption of game-changing data and digital healthcare solutions.”

MediView is utilizing augmented reality to address the long-standing limitations of current medical imaging technologies. Flat-panel monitors limit practitioners to 2D imaging and require them to look away from the patient’s procedural site, disrupting hand-eye-coordination, resulting in reduced clinician confidence and potentially impacting outcomes. 

Through Microsoft’s HoloLens 2 AR headset, clinicians can visualize the patient’s ultrasound, as well as displays of other procedural information to facilitate their workflow. MediView officials say that XR90 overcomes the limitations of 2D imaging by providing physicians with 3D “X-Ray vision” during procedures—the ability to visualize a patient’s comprehensive internal anatomy in 3D underneath their skin, including bone, tissue, organs, and vasculature. 

Moreover, the device projects 3D virtual models of the patient’s own anatomy based on their CT imaging and combines that CT with live ultrasound to perform minimally invasive procedures, such as biopsies and tumor ablations (the use of heat or cold to kill cancerous tumors).