BVI Medical has secured CE Mark certification under the European Union Medical Device Regulation (EU MDR) for its Virtuoso platform, positioning the system for commercial rollout across Europe later this year. The approval, granted in April 2026, enables the company to introduce the dual-function system to CE Mark-recognizing markets, with a European launch scheduled for the third quarter of 2026. Designed to support Eye Surgery procedures spanning both cataract and vitreoretinal interventions, the platform consolidates multiple surgical capabilities into a single system.
The Waltham, Massachusetts-based ophthalmic device manufacturer previously presented Virtuoso to the European surgical community during the 2025 EURETINA and European Society of Cataract and Refractive Surgeons (ESCRS) congresses. According to the company, the system is engineered to deliver stable intraocular pressure (IOP) management, controlled energy output, and advanced vitreous cutting and aspiration, all within a compact footprint intended to streamline operating room workflows. “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, reflecting BVI’s continued commitment to meaningful innovation in eye health.”
The platform is designed for anterior, posterior, and combined procedures, with a focus on multi-specialty centres and ambulatory surgical settings. It integrates proprietary technologies across fluidics, energy delivery, and workflow optimisation, including the Equality system for maintaining consistent target IOP, the inVITe valved entry system supporting intraoperative stability, and EvenFlow technology for controlled IOP during fluid-air exchange. The Resolute ultrasound system is intended to maintain consistent energy delivery regardless of lens hardness, while the Velvet probe enables high-speed dual-pneumatic cutting for vitreoretinal applications. The EasyFit setup system is designed to reduce operating room turnover time, reinforcing efficiency in Eye Surgery environments.
A prospective, single-centre, single-arm pre-market clinical investigation is currently underway at LMU Klinikum in Munich, Germany, led by Prof. Siegfried Priglinger, MD, with the first patient procedure completed in December 2025. Scientific data on system performance, including post-occlusion break surge, energy consistency, aspiration efficiency, and cutter stiffness, has been presented at the 2025 EURETINA, ESCRS, and FloRETINA congresses. The platform was also featured in a live surgical demonstration at the Munich Retina Meeting in early 2026. BVI stated that Virtuoso is designed to integrate with its broader portfolio of consumables and intraocular lenses, supporting its global presence across more than 90 countries.
