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.
More about the MediView XR90 platform
MediView’s augmented reality platform aims to address the long-standing limitations of medical imaging technologies. That includes the 2D imaging that requires practitioners to look away from the patient’s procedural site. This instance can disrupt hand-eye coordination and reduce the clinician’s confidence, potentially impacting outcomes.
Using Microsoft’s HoloLens 2 AR headset, clinicians can visualize ultrasound and displays of other procedural information to facilitate their workflow.
MediView says XR90 overcomes the limitations of 2D imaging with its 3D “x-ray vision.’ This enables clinicians to visualize a patient’s comprehensive internal anatomy in 3D underneath their skin. That includes bone, tissue, organs and vasculature, all projected in 3D virtual models based on CT imaging. It combines the CT with live ultrasound to perform minimally invasive procedures like biopsies and tumor ablations.
XR90 includes a holographic light ray that tracks and displays the path of a physician’s instrument, plus CT-based 3D holographic anatomy display. Its live ultrasound projects and displays anatomically into the patient as the clinician scans, like a flashlight beam.
MediView said it designed the system to provide visual information and reference for the analysis of procedural options. It helps during pre-operative planning, facilitates workflow and provides enhanced ergonomics to the user. The company says XR90 is indicated for use adjunctively to standard-of-care imaging.
“We are in a new era of visualization, collaboration, and data insights in healthcare that can create patient, clinician and financial benefits,” said 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.”
In May, MediView picked up a $15 million strategic funding round. Its investors include Mayo Clinic, Cleveland Clinic, GE HealthCare and more.