, 2025-04-17 18:35:00
April 17, 2025
1 min read
Key takeaways:
- Leos is used to perform laser endoscopic cyclophotocoagulation.
- BVI Medical plans to launch the system in the U.S. in the coming months.
Editor’s note: This is a developing news story. Please check back soon for updates.
The FDA granted 510(k) clearance for Leos, a laser endoscopy ophthalmic system for a more intuitive laser endoscopic cyclophotocoagulation procedure, according to a press release from BVI Medical.
The FDA granted 510(k) clearance to the Leos laser system.
Through a minimally invasive ab interno procedure, the laser system lowers IOP by addressing aqueous humor production while also providing “superior visualization of the eye anatomy in a way not seen in the past or with the latest in imaging systems,” the release said.
The clearance is supported by positive safety and efficacy data from a randomized controlled clinical trial. BVI aims to launch Leos in the U.S. in the coming months.
“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,” Mikhail Boukhny, vice president of global research and development at BVI, said in the release. “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.”