FDA clears glaucoma laser device from BELKIN Vision

(Image Credit: AdobeStock)

BELKIN Vision announced it has received FDA clearance for its glaucoma laser, the Eagle device.

According to a news release,¹ a Q-switched, 532 nm-wavelength, frequency-doubled Nd:YAG laser, the Eagle is intended for use in performing selective laser trabeculoplasty (SLT).

The company noted in its news release, the clearance marks an advancement in the field of ophthalmology, offering expanded treatment options for individuals suffering from glaucoma.¹

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.² The clearance of the Eagle by the FDA represents an 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.³

BELKIN Vision CEO Daria Lemann Blumenthal shows the company’s Eagle device, which has received FDA clearance. (Image courtesy of CNW Group/BELKIN Vision)

According to the company’s news release, the laser device 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.

Moreover, 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.¹

“This achievement has been possible thanks to the skill, passion, and dedication of our entire team,” Daria Lemann-Blumenthal, BELKIN Vision CEO, said in the news release. “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.”

References:

1 Vision, B. (2023) Belkin Vision announces FDA CLEARANCE FOR THE EAGLETM device, PR Newswire: press release distribution, targeting, monitoring and marketing. Published December 12, 2023. Accessed December 12, 2023. https://www.prnewswire.com/news-releases/belkin-vision-announces-fda-clearance-for-the-eagle-device-302012569.html.

2 Learn about Glaucoma | glaucoma.org. Published April 18, 2021. https://glaucoma.org/learn-about-glaucoma/

3 Glaucoma Summary Benchmarks - 2022. American Academy of Ophthalmology. Published December 1, 2022. Accessed October 7, 2023. https://www.aao.org/education/summary-benchmark-detail/glaucoma-summary-benchmarks-2020