BVI Medical’s Virtuoso platform has secured a CE mark under the European Union’s Medical Device Regulation (EU MDR), setting a course for the company to begin commercialising the cataract and vitreoretinal surgery platform across the region.
The Massachusetts-headquartered company’s next-generation Virtuoso platform is designed to support clinicians in conducting cataract and vitreoretinal procedures on a single, integrated platform. According to BVI, the platform has been designed to provide control during the eye procedures through the provision of intraocular pressure (IOP) control, consistent energy delivery, and advanced vitreous cutting and aspiration protocols.
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To ensure that eye care procedures in the operating room (OR) are streamlined, Virtuoso is equipped with features including Equality Fluidics Control, a management system designed to actively maintain a consistent target IOP throughout procedural steps, and Velvet Vitrectomy, a dual-pneumatic probe designed to equip clinicians with heightened control during posterior and anterior vitrectomy.
Designed to support anterior, posterior, and combined procedures, Virtuoso has been developed to meet the “evolving needs” across variant healthcare settings, including multi-speciality centres and ambulatory surgical centres, BVI added.
“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,” explained BVI’s CEO, Jim Hollingshead.
“With CE Mark certification under the EU MDR, 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,” Hollingshead continued.
BVI’s latest regulatory approval comes at a time when the ophthalmology specialist is ramping up efforts to contend with the biggest players in the eye care space, such as Alcon and Johnson and Johnson (J&J).
Alcon, J&J, and Bausch Health made up 35.6%, 15.7% and 7.5% of the IOL market in 2025, respectively, yet BVI Medical is trying to challenge the dominance of its competitors. To further this ambition, BVI raised $1bn in March 2025, funds that it plans to apply towards advancing its global footprint.
In October 2025, BVI gained US Food and Drug Administration (FDA) approval for FineVision HP, the world’s first trifocal intraocular lens (IOL) for cataract surgery.
According to GlobalData analysis, the IOL market is growing at a compound annual growth rate (CAGR) of 2.1% and is projected to reach $5.6bn in 2034. Meanwhile, the broader ophthalmic device market is projected to reach a $9.8bn valuation in 2033, driven by an increasing prevalence of eye diseases among ageing global populations, as per GlobalData.
