CE Mark under the European Union Medical Device Regulation (EU MDR) achieved for Virtuoso\u00ae, BVI\u2019s 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\u00ae\u2019s 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. <\/p>\n
WALTHAM, Mass., April 20, 2026 (GLOBE NEWSWIRE) — BVI, a global leader in ophthalmic device innovation, today announced that Virtuoso\u00ae has received the CE Mark under the European Union Medical Device Regulation (EU MDR), enabling commercialization across markets recognizing the CE Mark. Virtuoso\u00ae is BVI\u2019s next-generation phaco-vitrectomy surgical platform, a dual-function system designed to support both cataract and vitreoretinal procedures on a single, integrated platform.<\/p>\n
Virtuoso\u00ae 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\u2019s continued expansion in the premium surgical equipment segment and its broader mission to support surgeons with flexible, future-ready solutions.<\/p>\n
\u201cVirtuoso\u00ae 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,\u201d said Jim Hollingshead, President and CEO of BVI. \u201cWith 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\u2019s continued commitment to meaningful innovation in eye health.\u201d<\/p>\n
One Platform Designed for Multi-Specialty Excellence<\/p>\n
Virtuoso\u00ae 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:<\/p>\n
Equality\u2122 Fluidics Control. A proprietary intraocular pressure (IOP) management system designed to actively maintain a consistent target IOP throughout all procedural steps.Resolute\u2122 Ultrasound Delivery. An intelligent energy optimization system designed to deliver target energy regardless of lens hardness.Velvet\u2122 Vitrectomy Probe. A high-speed, dual-pneumatic, dual-blade vitrectomy drive designed for controlled and efficient posterior and anterior vitrectomy.EvenFlow\u2122 Automatic FAX. An automated fluid-air exchange solution providing machine-controlled IOP control during surgical media exchanges.inVITe\u2122 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\u2122 All At Once Setup. A streamlined operating room setup designed to reduce turnover time and improve procedural consistency. <\/p>\n
Clinical Validation<\/p>\n
As part of BVI\u2019s commitment to clinical collaboration and evidence generation, Virtuoso\u00ae 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.<\/p>\n
\u201cDuring this first phase of our clinical evaluation, Virtuoso\u00ae 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,\u201d said Prof. Siegfried Priglinger, MD, Chair of the Department of Ophthalmology at LMU Klinikum.<\/p>\n
The 2025 EURETINA, ESCRS, and FloRETINA congresses featured the first-ever Virtuoso\u00ae abstracts in their scientific programs, presenting data on post-occlusion break surge that demonstrated the system\u2019s 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\u00ae was featured in its first live surgery, demonstrating performance in a real-world surgical setting.<\/p>\n
Virtuoso\u00ae 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\u2019s 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.<\/p>\n
About BVI<\/p>\n
BVI\u00ae 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.<\/p>\n
To learn more about BVI and its mission to advance the future of vision, visit https:\/\/www.bvimedical.com<\/a><\/p>\n
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