Snke is preparing to launch SnkeXR, an open platform augmented reality (AR) headset specifically designed for the medtech industry.
Snke, which span out of German imaging company Brainlab in June 2025, unveiled the device at the Medical Device Innovation Consortium (MDIC) Medical Extended Reality (XR) summit, which took place in Maryland, US on 4-5 November.
The company’s device, claimed to be the first medical grade AR headset, is expected to begin shipping in Q2 2026. It is intended for use across areas such as imaging and orthopaedics. To enhance its specificity for clinical use, SnkeXR has several healthcare-centric features incorporated into its design.
For example, the device includes a built-in stereoscopic loupe for magnification of up for 3.5x during operative procedures on small structures, and a built-in depth camera to scan surface anatomy or organs at 30 frames per second.
As a medical grade product, Nissan Elimelech, general manager at Snke, told Medical Device Network the company is undertaking all of the relevant tests so the device is in full compliance with regulatory dictates such as the ISO standards for medical devices.
Elimelech said: “The safety and performance tests we are doing to ensure the device going to be compliant with all of the stringent regulatory and quality standards required by the US Food and Drug Administration (FDA) or under the European Medical Device Regulation (EU MDR).”
AR and virtual reality (VR) headsets are gradually gaining traction in areas like spine surgery, with GlobalData analysts stating that these techniques for advanced image visualisation are thought to “enhance surgical planning, provide better intraoperative guidance, and ultimately improve patient care” by increasing understanding of anatomy and surgical pathology.
A lack of AR options and medtech specificity
During his time as CEO at Augmedics, an AR technology-focused company, Elimelech said he recognised that the adoption of AR devices was not particularly good and that few companies had embraced the technology. According to Elimelech, the key reason was that there were simply no good enough AR platforms for companies to use to develop applications with for use in healthcare.
“What we're bringing is vendor neutral, open platform AR glasses for the medical industry,” Elimelech said.
“We’re making it easy for legal manufacturers, small and big, to use our glasses, to take them and develop their own proprietary applications and bring those to the market.”
The critical part of this, Elimelech says, relates back to the medical grade design of snkeXR versus consumer manufacturers of AR glasses that are not designed or built to support the medical industry in “the way that they should be”.
“Consumer AR devices are sold and the seller walks away,” Elimelech said. “They're not going to support the buyer if there's any complaint, any investigation, or any question by the FDA or other regulatory body regarding the technical aspects of the device and the tests that they need to go through.”
Elimelech highlights that Snke’s key differentiator is that it plans to partner with customers to get the AR glasses cleared and approved, with post marketing surveillance being addressed, too, thereby fostering an ongoing relationship with customers.
He continued: “It's not a one-time sale. We don't just sell and forget. We also carry the burden of doing the tests for the regulatory bodies. Customers will not need to do any of this because we're doing everything, including supplying relevant safety reports, either to our partners or to the FDA via a master file submission.
In the case of the FDA, the provision means that Snke will submit all the relevant technical files to the agency.
“No one will have to go through the test again. They will just reference our device, validate their clinical application, and get it cleared, instantly, on the market without doing any additional tests.”
