MediView's XR90 Augmented Reality-Based Visualization and Navigation Platform Receives FDA 510(k) Clearance

Friday, July 21, 2023

MediView XR, Inc., a leading clinical augmented reality med-tech company, has announced that it has received FDA 510(k) clearance for its groundbreaking XR90 augmented reality-based surgical visualization and navigation platform. The clearance covers the use of XR90 as an adjunct for minimally invasive ultrasound and CT guided needle-based procedures, focusing on soft tissue and bone applications.

This clearance is a significant milestone for MediView as it not only marks their first 510(k) clearance but also the first-ever clearance for an augmented reality device that combines live imaging with 3D XR visualization for pre- and intra-operative indications. This achievement paves the way for further advancements in the application of augmented reality in the healthcare space. The company expressed excitement about this clearance and extended appreciation to its team and the FDA for their collaboration in reaching this milestone.

The XR90 platform addresses the limitations of traditional two-dimensional imaging by providing physicians with a unique 3D "X-Ray vision" during procedures. It allows medical professionals to visualize a comprehensive 3D representation of a patient's internal anatomy beneath the skin, including bone, tissue, organs, and vasculature. This integration of CT-based 3D virtual models with real-time ultrasound enables precise and minimally invasive procedures like biopsies and tumor ablations.

XR90 comes with augmented reality capabilities, such as the Holographic Light Ray that tracks and displays the path of the physician's instrument, a CT-based 3D holographic anatomy display, and live ultrasound projected anatomically onto the patient as the clinician scans, similar to a flashlight beam. These features provide valuable visual information during pre-operative planning, enhance workflow efficiency, and offer improved ergonomics for clinicians with a heads-up, intra-operative display of medical images during ultrasound-guided needle procedures. XR90 is intended to be used alongside standard care imaging.

As a versatile imaging tool, XR90 revolutionizes the visualization of patient anatomy and instrumentation pathways while maintaining the natural alignment of the clinician's senses. Additionally, it enables real-time collaboration among clinicians at remote locations, facilitating shared visualization, communication, and guidance during procedures for collaborative patient care. This aspect proves especially beneficial for understaffed facilities, rural or underserved populations, and in situations where limiting caregiver and patient exposure to infectious diseases, like COVID-19, is crucial while maintaining high-quality care levels.



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