| Developers: | Belkin Vision |
| Last Release Date: | 2023/12 |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
The main articles are:
2023: Obtaining FDA Approval to Sell Eagle Laser
Israel-based medical device company Belkin Vision received 510 (k) approval from the U.S. Food and Drug Administration (FDA) in December 2023 to sell the Eagle laser, designed to treat glaucoma. This was announced on January 22, 2024 by the information and analytical, educational project of the Evercare.ru with reference to the Medical Device Network resource.
Q-switched laser [1], a wavelength of 532 nm and a double frequency is intended for use in selective laser trabeculoplasty. [2]
As noted, being the first contactless laser designed specifically for this disease, Eagle offers an automated, non-invasive solution for patients and healthcare professionals in the treatment of glaucoma. Glaucoma is one of the leading causes of irreversible blindness, affecting 70 million people worldwide (as of December 2023).
According to Belkin Vision, compared to traditional treatments, the device has a number of features. In particular, it directs laser energy directly through the limb into the trabecular mesh sheath during a non-contact procedure, eliminating the need for a gonioscopic lens. [3]
In addition, the device autonomously detects the target zone and performs a laser sequence, and the eye tracking sensor corrects any movement of the eyes.
Automated glaucoma laser therapy allows ophthalmologists to treat more patients anywhere and promotes the availability of first-line, drip-free glaucoma treatment.[4]
In May 2022, the company received a similar approval for the Eagle device from European regulators (CE Mark). [5]]
Notes
- ↑ A Q-switched laser, or Q-switched laser, is a laser of a special design that allows the generation of very powerful and short pulses
- ↑ Trabeculoplasty is an ophthalmic surgery aimed at creating auxiliary holes in the drainage system of the anterior eye chamber. It is shown in a number of forms of glaucoma.
- ↑ Gonioscopic lens is a transparent lens on which a medical gel is applied and applied directly to the cornea
- ↑ Laser that treats glaucoma
- ↑ [A laser that treats glaucoma Belkin Vision's glaucoma laser receives 510 (k) clearance from the FDA
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