The FDA has granted Class II clearance to NeoLight LLC for its ICON GO, a portable ophthalmic retinal imaging system with expanded fluorescein angiography (FA) capabilities.
First, give me a rundown on this company.
Based in Scottsdale, Arizona, NeuroLight is a medical device company centered around developing best-in-class technologies to treat preventable conditions in the newborn care market.
In addition to ocular screening, its areas of focus include jaundice care and non-nutritive sucking in premature infants.
What other ocular products does it have?
Among its offerings is the Phoenix CONNECT, a communication platform for delivering high-quality retinopathy of prematurity (ROP) screenings.
Talk about the ICON GO.
The ICON GO is a lightweight, portable retinal diagnostic system to deliver high-quality retinal imaging in the newborn patient care space (ICU, NICU, OR, and ER).
Using a proprietary Direct Illumination Technology, the system provides high-resolution and high-contrast imaging while minimizing scattering at the edge of the field of view.
Go on …
A single lens on the system is used to enable a comprehensive 100° wide field of view for retina surveying—facilitating illumination throughout the entire field of view with resolution comparable to a legacy 30º high mag lens, according to NeoLight.
How is it portable?
The system includes a low-powered, LED-supported handpiece with CMOS sensor technology that allows for low light levels (intended to reduce stress in sensitive patients).
A state-of-the-art light cable is also designed to remove heavy or fragile fiber-optic cables (to reduce costly repairs).
So how does it work?
Per the company, the system is designed to reduce work and error with DICOM integration.
Click here to view the process.
And the FA capabilities?
According to NeoLight, the addition of FA is “transformative” for diagnosing and managing retinoblastoma patients.
Significance?
NeoLight Chief Commercial Officer Marybeth Smith stated that, with this FDA clearance, “hospitals can now integrate ICON GO more holistically into their patient care,” bringing the company closer to providing universal newborn screening.
To note, the device is now the world’s only portable FDA-cleared retinal imaging system with expanded FA capabilities.
Where can I demo this?
To request a customized demo, click here (and scroll to the bottom of the page).
And when will it be available for purchase?
Per the company, the ICON GO with FA will be available in Q4 2023.