The system is designed to give surgeons a clear, real-time view of critical anatomy and planned trajectories.
Medivis has received US Food and Drug Administration (FDA) 510(k) clearance for its augmented reality (AR) cranial navigation platform for intraoperative guidance in cranial neurosurgery.
By using augmented reality to spatially map patient imaging within the operative field, the Medivis platform is designed to give 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, according to a release from the company.
“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,” says Dr Christopher Morley, president and co-founder of Medivis, in a release. “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.”
Today, external ventricular drains are misplaced at rates reported as high as 30%, often leading to repeated passes, patient harm, and delayed critical care, according to the company. By providing real-time, AR-guided visualization at the bedside, early clinical experience suggests Medivis can reduce these misplacements.
“For the first time, neurosurgeons can perform cranial procedures using augmented reality— merging the digital and physical worlds with high-accuracy guidance,” says 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 marks Medivis’ second major FDA clearance this year, following the launch of spine navigation. Medivis’ FDA clearances for Cranial Navigation and Spine Navigation can support reimbursement under established CPT add-on codes 61781 and 61783, respectively.
Photo caption: A first-person view of the cranial navigation platform
Photo credit: Medivis
