FDA OKs MediView XR’s AR-Based Visualization and Navigation

MediView XR, an augmented reality (AR) medtech company, has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its XR90 AR-based surgical visualization and navigation platform.
 
XR90 is meant to be used adjunctively for minimally invasive ultrasound and CT-guided, needle-based soft tissue and bone procedures.
 
“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.” Adam Cargill, Director of Quality, Regulatory and Clinical Affairs at MediView, told the press.
 
“MediView is excited to receive 510(k) clearance for our XR90 platform and appreciate the team’s efforts and FDA’s partnership in achieving this milestone. We are in a new era of visualization, collaboration, and data insights in healthcare that can create patient, clinician and financial benefits,” added Mina Fahim, president and CEO of MediView. “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.”
 
Using Microsoft’s HoloLens 2 AR headset, clinicians can visualize the patient’s ultrasound and displays of other procedural info. XR90 offers physicians 3D “x-ray vision”—the ability to visualize comprehensive anatomy in 3D underneath their skin, including bone, tissue, organs, and vasculature.
 
The device projects 3D virtual models of anatomy based on CT imaging and combines that CT with live ultrasound to perform minimally invasive procedures like biopsies and tumor ablations. XR90’s augmented reality capabilities include a Holographic Light Ray that tracks and displays the path of the physician’s instrument, CT-based 3D holographic anatomy display, and live ultrasound that is projected and displayed anatomically into the patient as the clinician scans, similar to a flashlight beam.
 
The system is designed to provide visual information and reference to clinicians for analysis of procedural options during pre-operative planning, to help facilitate workflow, and to provide enhanced ergonomics to the user for heads-up, intra-operative display of medical images during ultrasound-guided needle procedures. XR90 is indicated to be used adjunctively to standard of care imaging.