BVI Announces CE Mark Under EU MDR for Virtuoso®, A Brand New Dual-Function Surgical Platform

• CE Mark under the European Union Medical Device Regulation (EU MDR) achieved for Virtuoso®, BVI’s first dual-function phaco-vitrectomy platform designed to deliver advanced control, efficiency, and versatility for both cataract and vitreoretinal surgery.
• First patient successfully treated at LMU Klinikum in Munich, Germany, in December 2025. This milestone builds on Virtuoso®’s presence across key 2025 industry forums, including EURETINA, ESCRS, and FloRETINA, and continued into 2026 at the Munich Retina Meeting, where the platform was featured in its first live surgery, reinforcing its design focus on fluidics stability, workflow efficiency, and the real-world demands of ophthalmic surgery.

WALTHAM, Mass., April 20, 2026 (GLOBE NEWSWIRE) -- BVI, a global leader in ophthalmic device innovation, today announced that Virtuoso® has received the CE Mark under the European Union Medical Device Regulation (EU MDR), enabling commercialization across markets recognizing the CE Mark. Virtuoso® is BVI’s next-generation phaco-vitrectomy surgical platform, a dual-function system designed to support both cataract and vitreoretinal procedures on a single, integrated platform.

Virtuoso® is engineered to introduce a new level of control through novel fluidics, consistent energy delivery, advanced vitreous cutting and aspiration performance, and a seamless Operating Room (OR) workflow. CE Mark certification under MDR represents a major milestone in BVI’s continued expansion in the premium surgical equipment segment and its broader mission to support surgeons with flexible, future-ready solutions.

“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.”

One Platform Designed for Multi-Specialty Excellence

Virtuoso® is purpose-built to support anterior, posterior, and combined procedures, addressing the evolving needs of multi-specialty centers, ambulatory surgical centers, and high-efficiency operating environments. Key innovations include:

• Equality™ Fluidics Control. A proprietary intraocular pressure (IOP) management system designed to actively maintain a consistent target IOP throughout all procedural steps.
• Resolute™ Ultrasound Delivery. An intelligent energy optimization system designed to deliver target energy regardless of lens hardness.
• Velvet™ Vitrectomy Probe. A high-speed, dual-pneumatic, dual-blade vitrectomy drive designed for controlled and efficient posterior and anterior vitrectomy.
• EvenFlow™ Automatic FAX. An automated fluid-air exchange solution providing machine-controlled IOP control during surgical media exchanges.
• inVITe™ Valved Entry System. A flexible entry system with a high-flow directional infusion cannula designed to improve surgical efficiency and maintain stable intraoperative fluidics.
• EasyFit™ All At Once Setup. A streamlined operating room setup designed to reduce turnover time and improve procedural consistency.

Clinical Validation

As part of BVI’s commitment to clinical collaboration and evidence generation, Virtuoso® is currently being evaluated in a pre-market, prospective, single-center, single-arm clinical investigation at LMU Klinikum, Munich, Germany, led by Professor Siegfried Priglinger. The first patient procedure was successfully performed in December 2025, marking an important clinical milestone for the platform.

“During this first phase of our clinical evaluation, 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, and we look forward to further evaluating its performance as the study progresses,” said Prof. Siegfried Priglinger, MD, Chair of the Department of Ophthalmology at LMU Klinikum.

The 2025 EURETINA, ESCRS, and FloRETINA congresses featured the first-ever Virtuoso® abstracts in their scientific programs, presenting data on post-occlusion break surge that demonstrated the system’s responsiveness in recovering IOP stability. Additional findings highlighted energy delivery consistency, supporting the ability to maintain target energy and enabling lower energy setpoints, alongside enhanced aspiration efficiency versus leading platforms in both BSS and vitreous, and higher cutter stiffness without compromising efficiency at high degrees of bending. This scientific foundation was further extended into 2026 at the Munich Retina Meeting, where Virtuoso® was featured in its first live surgery, demonstrating performance in a real-world surgical setting.

Virtuoso® is positioned to compete at the highest tier of ophthalmic surgical systems, supporting providers seeking flexible, scalable, and cost-effective platforms. The system further strengthens BVI’s value proposition through seamless integration with its expanding portfolio of consumables and intraocular lenses. Commercial availability is expected to begin across Europe in Q3 2026, with expansion into additional international markets planned thereafter.

About BVI

BVI® is a leading innovator in eye health, with a long-standing legacy of shaping ophthalmic care through advanced technology. Building on nearly nine decades of expertise, from foundational surgical instruments to premium intraocular lenses and next-generation platforms, BVI partners closely with surgeons to deliver technology designed to support surgical performance and patient care. Serving surgical teams in more than 90 countries, BVI is committed to improving vision for patients worldwide.

To learn more about BVI and its mission to advance the future of vision, visit https://www.bvimedical.com

Press Contact
David Chavez
Global Communications Lead
dchavez@bvimedical.com
+1 (857) 869 8706

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