The US Food and Drug Administration (FDA) has granted 510(k) clearance for MediView XR’s augmented reality-based surgical visualisation and navigation platform, XR90.

The platform has been developed to be utilised adjunctively to carry out minimally invasive ultrasound and CT-guided needle-based procedures for soft tissue and bone.

During procedures, it provides physicians with 3D "X-Ray vision" to address the limitations of two-dimensional imaging.

This allows for the visualising of the comprehensive internal anatomy of patients in 3D underneath their skin, including vasculature, organs, tissue and bone.

The device creates 3D virtual models of the patient's anatomy using their CT imaging and integrates it with real-time ultrasound to carry out minimally invasive procedures like biopsies and tumour ablations.

The augmented reality capabilities of XR90 consist of a Holographic Light Ray, which tracks and shows the path of the physician's instrument.

Other capabilities include CT-based 3D holographic anatomy display and live ultrasound that is projected into the patient anatomically as the clinician scans.

Furthermore, the system offers visual information and reference to clinicians to analyse procedural options at the time of pre-operative planning.

This provides an intra-operative display of medical images during ultrasound-guided needle procedures. 

MediView president and CEO Mina Fahim said: “XR90 expands the MediView portfolio of solutions available to practitioners as they look to simplify, democratise and inform care delivery with the ultimate goal of improving and expanding access to the best care.

“Thank you to our employees, investors and partners for making this possible. We are just at the beginning of a journey seeing the clinical adoption of game-changing data and digital healthcare solutions.”