BVI's Virtuoso receives CE Mark for combined cataract and vitreoretinal surgery

BVI has obtained CE Mark certification under the European Union Medical Device Regulation (EU MDR) for Virtuoso, its dual-function surgical platform designed to perform both cataract and vitreoretinal procedures on a single system.¹ The certification enables commercialization across CE Mark-recognizing markets, with European commercial launch expected in the third quarter of 2026.¹

The Waltham, Massachusetts-based ophthalmic device company introduced Virtuoso to the European surgical community at the 2025 EURETINA and European Society of Cataract and Refractive Surgeons (ESCRS) congresses.² The system is engineered to provide intraocular pressure (IOP) management, consistent energy delivery, and advanced vitreous cutting and aspiration within a streamlined operating room workflow, with a footprint designed to optimize space in the OR, according to the company.^1,2

"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."¹

Platform design and key technologies

Virtuoso is intended for anterior, posterior, and combined procedures, targeting multi-specialty centers and ambulatory surgical environments.^1,2 The platform incorporates several proprietary technologies spanning fluidics, energy delivery, and surgical workflow.¹ On the fluidics side, the Equality system is designed to actively maintain a consistent target IOP across all procedural steps, while the inVITe valved entry system uses a high-flow directional infusion cannula to support intraoperative stability, and EvenFlow provides machine-controlled IOP management during fluid-air exchange.¹ For phacoemulsification, the Resolute ultrasound delivery system is designed to maintain target energy output independent of lens hardness.¹ Vitreoretinal cutting is handled by the Velvet probe, a high-speed, dual-pneumatic, dual-blade drive intended for both anterior and posterior vitrectomy.¹ The EasyFit setup system is designed to reduce operating room turnover time.¹

Ahead of the CE Mark approval, surgeons who had evaluated the platform offered early observations. Dr. Tommaso Rossi (Italy) noted that the fluidics architecture was designed to maintain target IOP throughout all procedural steps, combining characteristics of both flow and pressure pump designs, and that its load-sensing phaco capability may support consistent energy delivery regardless of lens resistance.² Dr. David Steel (UK) described the vitreoretinal performance as demonstrating strong aspiration capabilities across challenging scenarios, paired with high-speed dual-action cutting, including under load with a bent shaft.²

BVI added that Virtuoso is intended to integrate with its broader portfolio of consumables and intraocular lenses.^1,2

Clinical investigation

A prospective, single-center, single-arm pre-market clinical investigation is underway at LMU Klinikum in Munich, Germany, led by Prof. Siegfried Priglinger, MD, Chair of the Department of Ophthalmology, with the first patient procedure completed in December 2025.¹

Scientific presentations

Scientific abstracts covering post-occlusion break surge, energy delivery consistency, aspiration efficiency, and cutter stiffness were presented at the 2025 EURETINA, ESCRS, and FloRETINA congresses.^1,2 In early 2026, Virtuoso was featured in its first live surgery at the Munich Retina Meeting.¹

Availability

Commercial availability in Europe is targeted for Q3 2026, with expansion into additional international markets planned subsequently.¹ BVI operates in more than 90 countries.^1,2

REFERENCES

1. BVI announces CE Mark under EU MDR for Virtuoso, a brand new dual-function surgical platform. News release. BVI Medical. Published April 20, 2026. Accessed April 21, 2026. https://www.bvimedical.com/bvi-announces-ce-mark-under-eu-mdr-for-virtuosoa-brand-new-dual-function-surgical-platform/

2. BVI unveils Virtuoso – a novel dual-function surgical platform for cataract and vitreoretinal procedures. News release. BVI Medical. Published September 3, 2025. Accessed April 21, 2026. https://www.bvimedical.com/us/bvi-unveils-virtuoso-a-novel-dual-function-surgical-platform-for-cataract-and-vitreoretinal-procedures/