US-based medical technology company MediView XR has received the US Food and Drug Administration (FDA) 510(k) approval for its XR90 surgical visualisation and navigation platform.

XR90 is an augmented reality (AR) based platform intended to be used adjunctively for minimally invasive ultrasound and CT-guided needle-based procedures for soft tissue and bone.

It is a diverse imaging tool that provides a new approach to visualise patient anatomy and instrumentation pathway, while maintaining natural alignment of senses.

Also, XR90 allows clinicians to remotely collaborate in real-time to provide guidance during procedures for collaborative patient care.

The AR capabilities of the device include a Holographic Light Ray to track and display the path of the physician’s instrument and a CT-based 3D holographic anatomy display.

It also provides live ultrasound that is projected and displayed anatomically into the patient as the clinician scans, resembling a flashlight beam.

MediView president and CEO Mina Fahim said: “MediView is excited to receive 510(k) clearance for our XR90 platform and appreciates the team’s efforts and FDA’s partnership in achieving this milestone.

“We are in a new era of visualisation, collaboration, and data insights in healthcare that can create patient, clinician and financial benefits.

“XR90 expands the MediView portfolio of solutions available to practitioners as they look to simplify, democratize, and inform care delivery with the ultimate goal of improving and expanding access to the best care.”

According to the company, flat panel monitors require practitioners to look away from the patient’s procedural site, disrupting hand-eye coordination and limiting them to 2D imaging.

XR90 leverages Microsoft’s HoloLens 2 AR headset, which allows clinicians to visualise the patient’s ultrasound, along with displays of other procedural information.

It addresses the limitations of two-dimensional imaging by providing physicians with 3D X-Ray vision during procedures.

The 3D X-Ray vision helps visualise a patient’s complete internal anatomy in 3D underneath their skin, including bone, tissue, organs and vasculature.

XR90 projects 3D virtual models of the patient’s own anatomy based on their CT imaging and combines that CT with live ultrasound to perform minimally invasive procedures.

In May this year, MediView secured in a $15m strategic funding round with support from leading collaborators across clinical, industry and government.

Mayo Clinic, Cleveland Clinic, GE HealthCare, JobsOhio Capital Growth Fund, Inside View Investments, and KKVS Syndicate, among others, participated in the funding round.