BVI Medical Receives FDA 510(k) Clearance for the Leos Laser Endoscopy Ophthalmic System

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

Leos introduces a novel, intuitive laser ECP procedure designed to integrate seamlessly into the surgical workflow. According to BVI, it is the only laser system that lowers IOP by addressing aqueous humor production in a minimally invasive ab interno procedure, and incorporates endoscopic capabilities to provide superior visualization of the eye anatomy.

"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, Global R&D, said in a company news 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. 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.