MediView XR, an AR MedTech company, has received the FDA 510(k) clearance for its augmented reality (AR) surgical navigation system, XR90. The XR90 platform enables healthcare providers to visualize a patient's internal soft tissues, vascular, organ, and skeletal structures in 3D based on their CT images.

The XR90 platform combines CT imaging with ultrasound to display 3D holographic images anatomically beneath the patient's skin. This feature facilitates minimally invasive procedures like tumor ablations and biopsies. The platform also uses a Holographic Light Ray to track and display the path of a physician's instrument for surgical navigation. In March, MediView XR secured USD 15 million in strategic funding, and in December, it entered a know-how agreement with Mayo Clinic to accelerate innovation and advance procedural AR solutions.

Analyst QuickTake: Other MedTech companies that receive FDA clearance include AVATAR MEDICAL for its VR surgical planning solution ( June 2023 ); Augmedics’ launch of FDA-cleared features to its xvision AR spine imaging system ( March 2023 ); and apoQlar for its MR software platform, VSI HoloMedicine ( December 2022 ).