Key Takeaways

  • BVI’s Virtuoso platform has received CE Mark certification, enabling commercialization across Europe 
  • The dual-function system combines cataract and vitreoretinal capabilities in one platform
  • Early clinical evaluations and conference data highlight strong performance in IOP stability, energy consistency, and aspiration efficiency.

BVI announced that its next-generation surgical system, Virtuoso, has received the CE Mark under the European Union Medical Device Regulation (MDR). The certification enables commercialization of the platform across European markets and other regions that recognize the CE Mark.

Virtuoso is a dual-function phaco-vitrectomy system designed to support both cataract and vitreoretinal procedures within a single, integrated platform. The system aims to streamline surgical workflows while delivering enhanced precision and control across anterior and posterior segment procedures.

“Virtuoso represents a significant advance in surgical equipment design, bringing together precision, intuitive ease of use that supports OR efficiency, and world-class versatility for both the front and the back of the eye,” said Jim Hollingshead, President and CEO of BVI. “With CE Mark certification under the European Medical Device Regulation, we are making this leading-edge platform available to surgeons across Europe, designed to elevate surgical control, efficiency, and outcomes.”

Virtuoso has been engineered to address the evolving needs of multi-specialty surgical centers and high-efficiency operating environments. The platform incorporates several proprietary technologies aimed at improving performance and workflow, including:

  • Equality Fluidics Control, designed to maintain stable IOP throughout procedures
  • Resolute Ultrasound Delivery, which optimizes energy output regardless of lens density
  • Velvet Vitrectomy Probe, a high-speed dual-blade system for controlled vitreous cutting
  • EvenFlow Automatic FAX, enabling automated fluid-air exchange with precise IOP control
  • inVITe Valved Entry System, supporting stable intraoperative fluidics and efficient infusion
  • EasyFit All At Once Setup, reducing operating room setup time and improving consistency

Virtuoso is currently undergoing clinical evaluation at LMU Klinikum in Munich, Germany, in a prospective, single-center study led by Professor Siegfried Priglinger. The first patient procedure was successfully completed in December 2025.

“Virtuoso has demonstrated a thoughtful integration of fluidics stability, responsiveness, and workflow efficiency, designed with the realities of combined cataract and vitreoretinal surgery in mind,” said Prof. Priglinger. “We look forward to further evaluating its performance as the study progresses.”

With CE Mark approval secured, BVI said it plans to begin commercial rollout of Virtuoso across Europe in the third quarter of 2026, followed by expansion into additional international markets.