BELKIN Vision, an innovator in ophthalmic medical solutions, has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its glaucoma laser, the Eagle device. A Q-switched, 532 nm-wavelength, frequency-doubled Nd:YAG laser, the Eagle is intended for use in performing selective laser trabeculoplasty (SLT). This milestone achievement marks a significant advancement in the field of ophthalmology, offering expanded treatment options for individuals suffering from glaucoma.
Glaucoma is a leading cause of irreversible blindness, affecting 70 million people worldwide with more than 3.6 million diagnosed patients in the US alone.1 The clearance of the Eagle by the FDA represents a significant opportunity in the management of glaucoma, as the first and only contactless laser for glaucoma, providing an automated and non-invasive solution for patients and healthcare professionals alike. The American Academy of Ophthalmology recognizes laser trabeculoplasty as an initial or adjunctive therapy in patients with primary open-angle glaucoma.2
The Eagle is a state-of-the-art laser device that offers several advantages over traditional treatment options; the laser energy is delivered in a non-contact procedure directly through the limbus to the trabecular meshwork without the need for the use of a gonioscopy lens. In addition, the device automatically defines the target location and then applies the laser treatment sequence while the eye tracker compensates for any eye movement. By introducing Direct-SLT (DSLT), a streamlined, user-friendly technology, BELKIN Vision aims to expand access to early laser therapy for more patients by enabling a larger number of eye care professionals to perform the procedure.
BELKIN Vision CEO, Daria Lemann-Blumenthal states: ‘This achievement has been possible thanks to the skill, passion, and dedication of our entire team. We believe that this FDA clearance will have a positive impact on the lives of those affected by glaucoma, offering novel treatment methods and renewed hope for the future.’
About BELKIN Vision
BELKIN Vision is an innovative Israeli medical device company, established in 2013. its vision is accessible first-line glaucoma care for all. Visit the BELKIN Vision website to learn more.
1 https://glaucoma.org/learn-about-glaucoma/, https://www.cdc.gov/visionhealth/resources/features/glaucoma-awareness.html#:~:text=About%203%20million%20Americans%20have,results%20in%20increased%20eye%20pressure., Market Scope 2022 Glaucoma Surgical Device Market Report