MediView XR, Inc., a leading clinical augmented reality med-tech company, recently announced the 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for its pioneering XR90 augmented reality-based surgical visualization and navigation platform. XR90 is intended to be used for minimally invasive ultrasound and CT guided needle-based procedures in soft tissue and bone. This marks a significant achievement not only for MediView but for the entire medical community, as XR90 is the first augmented reality device with live imaging combined with 3D XR visualization for pre- and intra-operative use, paving the way for future advancements in healthcare augmented reality.
The XR90 platform expands the range of solutions offered by MediView to practitioners, aiming to simplify, democratize, and enhance care delivery with the ultimate goal of improving access to the best care. By utilizing augmented reality, MediView addresses the limitations of traditional medical imaging technologies. Conventional flat panel monitors provide 2D imaging, which requires clinicians to divert their attention from the procedural site, affecting hand-eye coordination and potentially impacting outcomes. In contrast, XR90 uses Microsoft's HoloLens 2 AR headset to enable clinicians to visualize the patient's ultrasound and display other relevant procedural information, streamlining their workflow.
The most significant innovation of XR90 lies in its ability to overcome the constraints of 2D imaging by offering physicians 3D "X-Ray vision" during procedures. This allows clinicians to visualize a comprehensive 3D virtual model of the patient's internal anatomy beneath the skin, including bones, tissues, organs, and vasculature. By combining CT imaging with live ultrasound, XR90 supports minimally invasive procedures like biopsies and tumor ablations with greater precision.
XR90's augmented reality features include the Holographic Light Ray, which tracks and displays the path of the physician's instrument, a CT-based 3D holographic anatomy display, and live ultrasound projection onto the patient's anatomy during scanning, similar to a flashlight beam. These features provide valuable visual information for clinicians during pre-operative planning, improve workflow during procedures, and offer enhanced ergonomics for heads-up, intra-operative display of medical images during ultrasound-guided needle procedures.
It's important to note that XR90 is intended to be used as an adjunct to standard of care imaging. The platform also serves as a diverse imaging tool, introducing a new way to view patient anatomy and visualize instrumentation pathways while maintaining natural alignment of the senses. Additionally, XR90 enables real-time collaboration among clinicians in remote locations, allowing shared visualization, communication, and guidance during procedures. This capability can be especially beneficial for understaffed facilities, rural or underserved populations, and can reduce caregiver and patient exposure to illnesses like COVID-19 while maintaining the quality of care.
https://www.prnewswire.com/news-releases/mediview-receives-fda-510k-clearance-for-xr90-augmented-reality-based-visualization-and-navigation-platform-301881541.html
