The FDA has cleared an augmented reality platform for real-time use during brain surgery—which its developer, Medivis, describes as a first for the field.
The company’s cranial navigation system follows up on an agency green light for its spine-focused platform earlier this year, which included both open and minimally invasive procedures. Both offer AR visualization and 3D instrument tracking, allowing surgeons to view digital scans alongside live patients and optimize the placement of their respective implants.
“For the first time, neurosurgeons can perform cranial procedures within an augmented environment that merges the digital and physical worlds with high-accuracy performance,” Medivis co-founder and CEO Osamah Choudhry, M.D., said in a statement. “This is a profound milestone not only for Medivis, but for the entire field of neurosurgery.”
In one example, the cranial 510(k) clearance enables the precise placement of external ventricular drains at the bedside in the intensive care unit, aided by a Microsoft HoloLens headset.
These temporary tubes are used to remove excess fluid from the brain, and Medivis estimates they are implanted incorrectly about one-third of the time. The company said its AR approach can significantly lower the need for repeat attempts during a lifesaving situation and greatly improve patient safety.
“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 the OR,” Choudhry added.
The system provides guidance based on 2D and 3D imaging data within the surgeon’s field of view, while mapping the patient’s anatomy, highlighting specific regions and being compatible with off-the-shelf hardware.
“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,” the company's co-founder and president, Christopher Morley, M.D., said in a statement. “This milestone not only attests to our technology but also lays the foundation for broad deployment of AR navigation across ICUs, ORs, and surgical centers worldwide, advancing a future where surgical intelligence improves outcomes in every clinical setting.”
Medivis, which is also developing a prostate navigation platform, previously raised $20 million through a series A venture capital round in 2023. The fundraising effort was led by Thrive Capital and joined by Initialized Capital and the Mayo Clinic. Other company backers have included Disney CEO Bob Iger and NBA champion Kevin Durant, the latter through his family investment office 35V.