MediView XR, Inc., a clinical augmented reality (AR) med-tech company, recently introduced its XR90 AR-based surgical visualization and navigation system for inpatient use after receiving FDA 510(K) clearance. The system is intended to be used adjunctively for minimally invasive ultrasound and CT-guided, needle-based procedures for soft tissue and bone.

The first worldwide clinical case, a mediastinal lymph node biopsy, was performed by Bradley B. Pua, MD, chief of the division of interventional radiology at NewYork-Presbyterian/Weill Cornell Medical Center and Weill Cornell Medicine in New York, and an associate professor of radiology at Weill Cornell Medicine in New York.

“We are pleased at the successful utilization of our holographic visualization and navigation system,” says Mina Fahim, president and CEO of MediView. “We are grateful to Dr.  Pua and his team for their collaboration and the many efforts of our early clinical investigation team at the Cleveland Clinic for pioneering the foundation of clinical and technical work to facilitate game-changing care for patients.”

“This is an incredible milestone for MediView and the medical AR space, marking just the beginning of the potential impact of MediView’s AR ecosystem on disrupting—and democratizing healthcare,” Fahim adds.

MediView is utilizing AR to address the long-standing limitations of current medical imaging technologies. Flat panel monitors limit practitioners to 2D imaging and require them to look away from the patient’s procedural site, which can disrupt hand-eye-coordination and potentially impact outcomes. Through Microsoft’s HoloLens2 AR headset, clinicians can visualize the patient’s holographic ultrasound to facilitate their workflow. 

XR90 overcomes the limitations of 2D imaging by providing physicians with 3D “X-Ray vision” during procedures—the ability to visualize a patient’s comprehensive internal anatomy in 3D underneath their skin, including bone, tissue, organs, and vasculature. The device projects 3D images of the patient’s own anatomy based on their CT imaging and fuses that CT with live ultrasound to perform minimally invasive procedures, such as biopsies and tumor ablations (the use of heat or cold to kill cancerous tumors).

MediView XR90’s AR 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 on 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, intraoperative display of medical images during ultrasound-guided needle procedures. The system also enables clinicians at remote locations to collaborate real-time with shared visualization, communication, and the ability to provide guidance during procedures for collaborative patient care.

Pua indicates that during the case, the tumor was not easily visible using ultrasound alone, but with the XR90 system, he was able to use the holographic anatomy to locate the targeted site. Pua then used the holographic needle tracking feature of the XR90 system to plan his approach before confirming on standard of care. 

“The system showed clinical utility and was a benefit to the patient to be able to correlate a CT that definitively identified the anomaly with what was displayed on live ultrasound,” Pua adds.