NEW YORK, Dec. 16, 2025 /PRNewswire/ — Medivis Inc., a pioneer in surgical intelligence, today announced it has received FDA 510(k) clearance for its Cranial Navigation platform – making it the world’s first augmented reality (AR) system cleared for intraoperative guidance in cranial neurosurgery. This marks Medivis’ second major FDA clearance this year following the launch of Spine Navigation.

By using augmented reality to spatially map patient imaging within the operative field, the Medivis platform gives surgeons a clear, real-time view of critical anatomy and planned trajectories. This approach can support faster, more confident decision-making during cranial procedures while minimizing workflow disruption and reducing dependence on external monitors. The platform’s portable design enables reliable image guidance in settings where conventional systems fail – especially the ICU – extending image-guided precision to a wider range of clinical environments.

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 – directly improving patient safety, accelerating life-saving interventions, and raising the standard of care across neurosurgery.

“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.”

“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.”

Medivis’ Cranial Navigation sets a new standard in neurosurgery, delivering advanced capabilities that can support enhanced precision, safety, and efficiency:

Surgical Intelligence: Combining proprietary computer vision, segmentation, real-time data analysis, and advanced image processing to deliver context-aware guidance throughout the workflow.
Ergonomic Freedom: Lightweight AR hardware keeps critical information in the surgeon’s line of sight, reducing attention shifts away from the operative field.
Seamless Integration: The platform streamlines data-driven decision-making in routine settings and previously inaccessible environments, including bedside procedures in the ICU.

Medivis’ FDA clearances for Cranial Navigation and Spine Navigation can support reimbursement under established CPT add-on codes 61781 and 61783, respectively. Medivis is accelerating the adoption of augmented reality across multiple specialties and care settings, paving the way for surgical intelligence to become a standard worldwide.

About Medivis

Medivis is a leading surgical intelligence company dedicated to pioneering the future of surgical navigation with artificial intelligence and augmented reality. To learn more, visit www.medivis.com.

Media contact:
Brooke Williams, [email protected]