MediView, a pioneer in extended reality (XR) surgical guidance, has initiated a multicenter clinical study to evaluate the efficacy and procedural advantages of its XR90™ Augmented Reality Surgical Navigation Platform for percutaneous soft tissue tumor biopsy. XR90, which received FDA 510(k) clearance (K223125), uses holographic 3D visualization to guide clinicians in real time, enhancing anatomical orientation and instrument navigation during procedures. By integrating augmented reality with standard-of-care imaging modalities like ultrasound and CT, the system aims to streamline interventional workflows and improve overall procedural precision.

The clinical study, titled “Clinical Evaluation of an Intra-procedural 3D Needle Guidance Platform for Performing Percutaneous Soft Tissue Tumor Biopsy,” is being conducted across several prominent U.S. healthcare institutions, including NewYork-Presbyterian/Weill Cornell Medical Center, MedStar Georgetown University Hospital, and MedStar Washington Hospital Center. With a target enrollment of 104 patients over 24 months, the study will compare standard imaging techniques with and without the adjunct use of XR90 to assess procedural efficiency, utility, and clinical outcomes. This marks a critical step in generating evidence to support the adoption of extended reality tools in interventional radiology and oncology practices.

This study underscores MediView’s commitment to transforming minimally invasive procedures through innovative, clinician-centered technology. By enabling enhanced spatial awareness and real-time needle guidance, XR90 has the potential to reduce procedure time, improve targeting accuracy, and boost clinician confidence, particularly in complex or hard-to-reach lesions. The outcome of this trial could pave the way for broader integration of AR-based platforms in image-guided interventions, reaffirming MediView’s role in advancing the next generation of precision medicine tools.

MedTech Spectrum's Summary

Innovative AR Technology in Biopsy Guidance: MediView’s FDA-cleared XR90™ platform introduces augmented reality-based 3D visualization to enhance precision and efficiency in percutaneous soft tissue tumor biopsies.

Robust Multicenter Clinical Validation: The ongoing 104-patient study across top U.S. medical centers aims to evaluate the added value of XR90 as an adjunct to standard imaging techniques like ultrasound and CT.

Advancing Image-Guided Intervention: The study could accelerate the adoption of extended reality in interventional radiology, supporting MediView’s mission to improve procedural outcomes and clinician workflow.