Perivision VisionOne gets CE-Mark

Perivision has received the EU CE-certification for its 1st medical software product VisionOne.

PeriVision, an innovative spin-off from the University of Bern and the University Hospital Bern, and now based at Biopôle in Lausanne, has received the EU CE-certification for its 1st medical software product VisionOne. VisionOne addresses the large unmet clinical need for more efficient and patient-friendly visual field testing, a routine eye test for glaucoma diagnosis and monitoring.

With over 80 million living with the disease, glaucoma is the leading cause of irreversible blindness globally. With VisionOne, ophthalmologists and optometrists can easily configure visual field tests on portable VR headsets and subsequently analyze the results on a cloud platform. Algorithms optimize the eye tests, automate assistance and control quality.

At the core of the product lies PeriVision’s patented visual field testing algorithm SORS (Sequentially Optimized Reconstruction Strategy). In clinical studies it has demonstrated the ability to reduce test time dramatically, while maintaining high accuracy.

Patrick Kessel, Perivision’s CEO, emphasises that the CE-certification was achieved after a substantial effort to prove the safety, efficacy, and clinical impact of the VisionOne device: “Given that the EU has probably the most demanding regulatory requirements in the world, we achieved this milestone in a comparatively short time. This success was in the end also possible through the incredible efforts of our regulatory team and the know-how and support from our regulatory partners Effectum Medical. Now, we look forward to bringing VisionOne’s diagnostic capabilities and benefits to patients and eye doctors across Europe.”

PeriVision The CE-mark opens the door for Perivision to expand its market presence across Europe, bringing its innovative diagnostic technology to clinicians and patients in need.

PeriVision soon available through distributors in UK, Spain, Greece & Cyprus

Anticipating the CE-marking, our team did not sit idle over the last months and worked hard to prepare our EU go-to-market. PeriVision was founded with the mission to make eye testing accessible to everyone, everywhere. Therefore, we are proud that VisionOne will soon be available through international distribution partners in the UK, Spain, Greece, and Cyprus!

➡️ Source: Press Release