Medivis, a company focused on surgical intelligence, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Cranial Navigation platform.

According to the company, this is the world’s first augmented reality (AR) system cleared for intraoperative guidance in cranial neurosurgery. It also marks Medivis’ second major FDA clearance this year, following rollout of Spine Navigation.

The Medivis platform provides surgeons with a clear, real-time view of critical anatomy and planned trajectories by using AR to spatially map patient imaging in the operative field. The approach can support quicker, more confident decision-making during cranial procedures while minimizing workflow disruption and dependence on external monitors.

Today, external ventricular drains (EVDs) are misplaced at rates reported as high as 30%, often leading to repeated passes, patient harm, and delayed critical care. By providing real-time, AR-guided visualization at the bedside, early clinical experience suggests Medivis can significantly reduce these misplacements.

The Cranial Navigation tool aims to set a new standard in neurosurgery. Surgical intelligence combines computer vision, segmentation, real-time data analysis, and advanced image processing to deliver context-aware guidance. Lightweight AR hardware keeps critical information in the surgeon’s line of sight, reducing attention shifts away from the operative field.

The platform also streamlines data-driven decision-making in routine settings and previously inaccessible environments, including bedside procedures in the ICU.

“For the first time, neurosurgeons can perform cranial procedures using augmented reality – merging the digital and physical worlds with high-accuracy guidance,” said Dr. Osamah Choudhry, CEO and co-founder of Medivis. “This is a profound milestone not only for Medivis, but for the entire field of neurosurgery. With this clearance, we’re bringing image-guided navigation to the ICU, where it hasn’t been possible before, giving clinicians greater precision at the bedside and helping support safer care for patients, while paving the way for full integration into operating rooms.”

Medivis’ FDA clearances for Cranial Navigation and Spine Navigation can support reimbursement under established CPT add-on codes 61781 and 61783, respectively.

“This achievement reflects an extraordinary collaboration between our team and the FDA, whose leadership and shared commitment to elevating patient care made this innovation possible,” said Dr. Christopher Morley, president and co-founder of Medivis. “This milestone not only attests to our technology’s capabilities but also lays the foundation for broad deployment of AR guidance across ICUs, operating rooms, and surgical centers worldwide—advancing a future where surgical intelligence improves outcomes in every clinical setting.”