Norlase has received 510(k) clearance from the FDA for LYNX, a pattern-scanning laser indirect ophthalmoscope (LIO).
This U.S.-based regulatory news coincided with the laser also receiving a CE Mark—the European Union equivalent of an FDA clearance.
Two for one–wow! But first: Refresh me on Norlase.
Founded in 2014 and based in Denmark—with U.S. headquarters in Redwood City, California, Norlase is a global ophthalmic medical device company developing next-generation laser solutions to treat retina and glaucoma disease.
In addition to the new LYNX, the manufacturer's product portfolio of ophthalmic lasers extends to:
- ECHO→ portable scanning laser photocoagulator with micro-electromechanical (MEMS) scanning technology for rapid pattern delivery
- Note: The FDA granted 501(k) clearance in May 2023
- LEAF→ green laser system; ultra-compact laser photocoagulator
- LION→ fully integrated, ultra-compact green laser (LIO) with fiber optic built into the headset
Now before we get to this new addition, explain LIO.
Utilized by retinal specialists, LIO is a laser delivery system that enables a wider view of the retina without needing to dilate a patient’s pupil.
What it entails: The device uses a targeted laser beam and condensing lens to create an inverted image of the retina on the ophthalmoscope’s viewing optics (thus, enabling an “indirect” and wider view).
- From an industry perspective: It can be key for identifying and treating such diseases like:
- Retinopathy of prematurity (ROP)
- Peripheral retinal diseases
- Retinal tears
- Diabetic retinopathy (DR)
And how does this compare to direct ophthalmoscopy?
With direct, the device provides an upright, unreversed image of the retina with an estimated 15x magnification.
- Comparatively: LIO features a reversed and inverted image with 2 to 5x magnification.
- Importantly: It also delivers a more powerful source of light.
Gotcha. Now talk about the LYNX.
LYNX is a rechargeable battery-powered, pattern-scanning LIO designed to give ophthalmic surgeons the ability to treat patients “virtually anywhere," according to Norlase.
- Its claim to fame: This is also the world’s first fully-integrated pattern LIO.
And how long does the battery last?
Integrated into the system’s footswitch, a single charge of the battery is designed to provide more than a full day of use.
Dive more into this portability.
The LIO’s laser and pattern module is built directly into the ergonomic headset, removing any need for an external laser source.
- How this is done: Via the use of Norlase’s MEMS scanning technology (also incorporated in the LION) that allows for a miniaturized scanning source to be integrated directly into the headset.
Plus: Fiber optics are also built into the headset to (ideally) enable surgeons to move freely and minimize any disruptive service repairs.
Go on …
Other features include an intuitive, wireless user interface and multilingual voice control of patterns and parameters on a tablet to provide clinicians “more options to streamline their treatment flow.”
What else?
Aside from the laser, scanner, and delivery system all being fully integrated in the headset, the LYNX also offers:
- Full pattern palette (2x3 to 5x5 grids, triple arcs, and circle)
- simplyCLEAR safety filters (for advanced visualization)
Size-wise: The laser is reported to weigh “no more than your traditional diagnostic [binocular indirect ophthalmoscope]” and requires just the headset, wireless tablet, and footswitch to treat patients.
I need a visual of this.
https://vimeo.com/user117022053
What did the company have to say about the clearance?
CEO and co-founder Oliver Hvidt noted that, for ophthalmologists today, the most important resource is time.
“Faster LIO treatments means less ergonomic stress, more quality time with patients and more practice days that end on time,” he stated.
And lastly, when is this launching?
That’s the best part … now!
In reporting its regulatory clearance, Norlase also announced the immediate U.S. commercial launch of LYNX.
Click here to contact a Norlase representative about adding this to your practice.