Medivis First to Receive FDA Clearance for Augmented Reality Navigation in Neurosurgery

Medivis has received FDA 510(k) clearance for its AR-powered Cranial Navigation platform, which the company and multiple reports describe as the world’s first augmented reality system cleared for intraoperative guidance in cranial neurosurgery.1 2 4 6 8

The cranial navigation clearance follows Medivis’ earlier 2025 FDA clearance for its AR spine navigation platform, marking the company’s second major U.S. clearance this year.2 3 6

Using augmented reality headsets, the platform spatially maps 2D and 3D patient imaging directly into the surgeon’s field of view, providing real-time visualization of critical anatomy and planned trajectories without relying on external monitors.1 2 3 4

A key early application is precise placement of external ventricular drains (EVDs) at the ICU bedside; EVDs are currently misplaced in up to about 30–33% of cases, and Medivis reports that AR-guided visualization can substantially reduce these misplacements and repeat passes.1 2 3

The system is designed to extend image-guided neurosurgery beyond the operating room into intensive care units and other bedside settings where conventional navigation systems are difficult to use, aiming to improve speed, safety, and access to advanced guidance.1 2 3

Medivis describes its platform as a “surgical intelligence” system that integrates proprietary computer vision, segmentation, real-time data analysis, and advanced image processing to deliver context-aware guidance throughout the neurosurgical workflow.1 2

The AR hardware is lightweight and ergonomically designed to keep information in the surgeon’s line of sight, reducing attention shifts away from the operative field and minimizing workflow disruption during cranial procedures.1 2 3 4

Medivis’ FDA clearances for Cranial Navigation and Spine Navigation can be billed under existing CPT add-on codes 61781 (cranial) and 61783 (spine), supporting reimbursement and broader clinical adoption.1 4

Company leaders, including CEO Dr. Osamah Choudhry and President Dr. Christopher Morley, characterize the clearance as a milestone for neurosurgery that enables broad deployment of AR navigation across ICUs, operating rooms, and surgical centers worldwide.1 2 3

Medivis positions this clearance as a foundation for expanding its AR-based surgical navigation into additional specialties, with ongoing development such as a prostate navigation platform and a broader vision for AR-driven surgical intelligence across clinical settings.3 9