BVI Medical has announced FDA 510(k) clearance for its new Leos Laser Endoscopy Ophthalmic System, according to a press release. The minimally invasive device offers a more intuitive approach to endoscopic cyclophotocoagulation (ECP), aimed at reducing intraocular pressure by targeting aqueous humor production.
Leos is the only laser platform of its kind to incorporate endoscopic visualization for enhanced anatomical clarity, streamlining its integration into surgical routines. The system is designed for use in a wide range of glaucoma cases, including early-stage disease.
“This milestone reflects our dedication to innovation and growth in key global markets,” said BVI President and CEO Shervin Korangy. The clearance follows a $1 billion capital raise and builds on recent product approvals in Europe and Asia.
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