Beyeonics Vision has completed the CE Mark registration for its Beyeonics One ophthalmic exoscope

Beyeonics Vision, a medical device company, announced today that it has completed the registration process and received the CE Mark in Europe for its patented Beyeonics One, a fully digital 3D surgical visualization platform.

Beyeonics One™ is the first ophthalmic exoscope, designed to deliver enhanced and magnified visualization of the surgical field and on-demand consolidated pre- and intra- operative information – all of which are naturally accessible and controlled by an immersive augmented reality surgical headset.

Prof. Paulo Eduardo Stanga, Vitreoretinal Surgeon and Director at The Retina Clinic in London, UK, commented about his clinical experience during his visit to the Tel Aviv Medical Center, Israel, where he himself operated patients: “I was very impressed by the short learning curve and perhaps most importantly by the immersive experience I got as a surgeon: it felt like being inside the eye itself during surgery and I found this especially helpful when treating the vitreoretinal periphery. I believe this is a game-changing technology for Vitreoretinal surgery.”

The Beyeonics One™ exoscope provides high magnification and clear, detailed image of the surgical field with zero perceived latency. In addition to the automated focus, panning, and controlled illumination, surgeons’ filter selection enables enhanced tissue and membrane contrast. The untethered visualization via the AR surgical headset allows the surgeon to maintain a continuous view of the surgical field without losing hand-eye coordination while adopting a more natural and ergonomic operational posture.

Ron Schneider, CEO and Co-founder of Beyeonics: “We are very proud of obtaining a CE mark that will allow us to bring our evolving platform technology to Europe. The company plans to build on the clinical and operational experience gained from over 2,000 surgeries performed in the US, to commence its market development activities in the European region in the near future.”

The Beyeonics One evolving platform technology is inspired by pilots’ head-mounted display technologies originally developed by a leading global aviation company and is designed to address the present and future surgical needs in ophthalmology.