BELKIN Vision Announces FDA Clearance For The Eagle Device

YAVNE, ISRAEL, Dec. 12, 2023 /PRNewswire/ - [BELKIN Vision], an innovator in ophthalmic medical solutions, is pleased to announce 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 which 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 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. Our vision is accessible first-line glaucoma care for all. Visit the BELKIN Vision website to learn more.

Connect with us at www.belkin-vision.com, on LinkedIn, Instagram and YouTube.

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

² https://www.aao.org/education/summary-benchmark-detail/glaucoma-summary-benchmarks-2020

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SOURCE BELKIN Vision

First published on Tue, Dec 12, 2023

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