BVI Medical receives 510(k) FDA clearance for glaucoma surgical system

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BVI Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its glaucoma surgical system, called Leos (Laser Endoscopy Ophthalmic System).

Leos is designed to introduce a novel, intuitive Laser ECP procedure that can integrate seamlessly into the surgical workflow. Notably this is the only laser system that lowers IOP by addressing aqueous humor production in a minimally invasive ab interno procedure. The system also has unique endoscopic capabilities to provide enhanced visualization of the eye anatomy. Leos is supported by emerging data from a randomized controlled clinical trial, further validating its safety and efficacy.

In the company’s press release, Shervin Korangy, BVI President and CEO, commented on this clearance, saying, "This momentous milestone underscores our commitment to innovation. We have been building a strong pipeline that is starting to play out in numerous geographies across the world, including Leos in the US market."

Mikhail Boukhny, vice president, Global R&D for BVI, added, "The development of Leos was driven by a deep understanding of the challenges clinicians face in managing glaucoma, such as visualization and access to target tissue. Our goal was to create a system that not only offers a novel and effective treatment approach but also enhances the surgical experience through improved intuitiveness, precision, and ease of use. This 510(k) clearance is a testament to years of effort, and we are excited to bring this groundbreaking technology to physicians and their patients."

BVI Medical anticipates launching Leos commercially in the US in the coming months.

Reference

Laser Endoscopy Ophthalmic System: Leos. BVI Medical. April 17, 2025. Accessed April 17, 2025. https://www.globenewswire.com/news-release/2025/04/17/3063574/0/en/BVI-Medical-Announces-Approval-of-Breakthrough-Technology-FDA-510-k-Clearance-of-its-Laser-Endoscopy-Ophthalmic-System-Leos.html