BVI Medical announced today that it received CE mark for its Virtuoso next-generation phaco-vitrectomy surgical platform.
Waltham, Massachusetts-based BVI designed its dual-function system to support both cataract and vitreoretinal procedures in a single, integrated platform. The company aims to redefine control and accuracy in ophthalmic surgery with its Virtuoso system. BVI included advanced technologies across fluidics control, vitreoretinal applications, ultrasound delivery and usability.
Virtuoso offers a single, high-performance platform with a footprint that optimizes space in the operating room. It addresses the needs of the growing number of ambulatory surgical centers (ASCs) and hospitals seeking flexible, cost-effective options. The system also strengthens BVI’s value proposition by coupling its portfolio of consumables and intraocular lenses (IOLs).
BVI unveiled Virtuoso in September 2025. The company says CE mark “represents a major milestone” as it looks to continue expanding in the premium surgical equipment segment. It hopes to support surgeons with flexible, future-ready solutions.
The company plans to make Virtuoso commercially available across Europe in the third quarter, expanding into additional markets thereafter. It also has Virtuoso under evaluation in a pre-market, prospective, single-center, single-arm study.
“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.”
