AR Medical Company MediView Receives FDA 510(k) Clearance for XR90 Platform

July 20th – Healthcare Augmented Reality (AR) Medtech CompanyMediView XR Announces Its Augmented Reality-Based Surgical Visualization and Navigation PlatformXR90Has received 510(k) clearance from the US Food and Drug Administration (FDA).

MediView utilizes augmented reality to address some of the limitations of current medical imaging technology associated with flat-panel displays that limit practitioners to 2D imaging and require them to move away from the patient's surgical site. The company's XR90 device is intended to complement standard-of-care imaging for minimally invasive ultrasound- and CT-guided puncture procedures of soft tissue and bone.

The device projects a 3D virtual model of the patient's own anatomy based on the patient's CT imaging, and combines CT with real-time ultrasound to perform minimally invasive procedures such as biopsy and tumor ablation (killing cancer cells using heat or low temperature).

The augmented reality capabilities of the XR90 include holographic ray tracing and showing the path of a doctor's instruments, CT-based 3D holographic anatomical display, and projecting and displaying dynamic ultrasound inside a patient like a flashlight beam.

via Microsoft'sHoloLens 2 Augmented reality headsets that allow clinicians to visualize ultrasound images of patients and display other surgical information to facilitate workflow. According to MediView, the XR90 overcomes the limitations of two-dimensional imaging by providing physicians with 3D "radiography" during surgery, which enables visualization of a patient's comprehensive internal anatomy, including bones, tissues, organs and blood vessels, beneath the patient's skin.

"The XR90 expands MediView's portfolio of solutions available to practitioners who are committed to simplifying, democratizing and enhancing care in healthcare to improve and expand access to optimal healthcare," said Mina Fahim, MediView's President and CEO.

MediView's technology also enables clinicians in remote locations to collaborate in real time, sharing visualizations, communicating and providing guidance during procedures to coordinate patient care. According to MediView, these capabilities can provide additional support for understaffed facilities, rural or unserved populations, and limit the risk of exposure to COVID-19 for caregivers and patients while maintaining care levels.

Commenting on the announcement, Adam Cargill, MediView’s Director of Quality, Regulatory and Clinical Affairs, said: “Not only is MediView’s first 510(k) clearance, but it is also the first augmented reality device to receive 510(k) clearance for a combination of real-time video and 3D XR visualization, laying the foundation for further advancements in augmented reality in healthcare.”

MediView recently announced a $15 million strategic funding round to expand its augmented reality surgical navigation platform. To learn more about MediView's augmented reality solutions for medical imaging, visit the company's website.