PeriVision receives CE marking for its VisionOne glaucoma diagnostics device

PeriVision, a Bern-based start-up, has received CE Marking for its VisionOne device, allowing it to be sold throughout Europe.

PeriVision, a spin-off from the University of Bern and the Inselspital, has achieved EU CE-certification for its VisionOne device, marking a significant milestone in advancing glaucoma diagnostics. This certification enables PeriVision to bring VisionOne to markets across Europe, providing ophthalmologists and optometrists with a more efficient, portable solution for visual field testing. With over 80 million people affected by glaucoma globally, VisionOne addresses a critical need for improved and accessible diagnostic tools to help prevent irreversible blindness.

The VisionOne system operates on wearable VR headsets and streamlines the visual field testing process. At the core of this technology is PeriVision’s proprietary Sequentially Optimized Reconstruction Strategy (SORS) algorithm, which significantly reduces testing time while maintaining high diagnostic accuracy. The system’s cloud-based platform further enhances the user experience by allowing clinicians to analyze results and monitor patient progress with automated quality control and optimized test configurations.

CE-certification is a major achievement for PeriVision, requiring rigorous safety and efficacy testing. Patrick Kessel, CEO of PeriVision, highlighted the collaborative efforts behind this success: “This success was possible through the incredible efforts of our regulatory team and the know-how from our partners at Effectum Medical. We are thrilled to bring VisionOne’s diagnostic capabilities to patients and eye care professionals across Europe.”

With the CE mark secured, PeriVision is positioned to expand its European presence. The company has already signed distribution agreements in Switzerland, Liechtenstein, Spain, Greece, Cyprus and the UK, with clinics placing initial orders through these channels. PeriVision offers VisionOne through a dual business model: a Software-as-a-Service (SaaS) subscription and a one-time purchase with a service fee, providing flexibility for eye care providers.

This certification builds on PeriVision’s ongoing efforts to transform ophthalmic diagnostics. Earlier this year, PeriVision received a CHF 1.1 million grant in collaboration with the Inselspital and the University of Bern to develop AI-driven eye tests for retinal diseases, expanding its focus from glaucoma to broader ophthalmic needs.