SCOTTSDALE, AZ - August 8, 2023 — NeoLight, a healthcare technology leader in neonatal care, is pleased to announce FDA Class II clearance for the world's only portable ophthalmic retinal imaging system with expanded Fluorescein Angiography (FA) capabilities—ICON™ GO. This significant clearance fortifies ICON™ GO as an indispensable tool in retinal diagnostics, offering unparalleled retinal imaging quality across diverse patient care environments such as the PICU, NICU, OR, and ER.
"Securing FDA clearance for Fluorescein Angiography with ICON™ GO is not just a milestone but a testament to NeoLight's relentless commitment to innovation and elevating patient care standards," said Vivek Kopparthi, Co-founder & CEO of NeoLight.
Embodying a unique blend of portability, cost-effectiveness, and uncompromised image quality, ICON™ GO sets the gold standard in portable retinal imaging. The addition of FA capabilities is transformative, particularly in the diagnosis and management of retinoblastoma patients.
"Following this FDA clearance, hospitals can now integrate ICON™ GO more holistically into their patient care strategy. Its expanded capabilities bring us closer to universal newborn screening and demonstrate NeoLight's global commitment to the ROP industry," commented MaryBeth Smith, Chief Commercial Officer of NeoLight.
Designed to empower clinicians across the continuum of care for screening and treating newborns, ICON™ GO employs proprietary Direct Illumination technology. This ensures high-resolution and high-contrast retinal imaging, particularly beneficial for darkly pigmented fundi. It is meticulously optimized to minimize scatter at the edge of the field of view.
The ICON™ GO with FA is available for purchase Q4 2023, solidifying NeoLight's drive to impact healthcare both domestically and globally. The release of ICON™ GO with FA capabilities aligns with NeoLight’s overarching ambition to serve a global patient base, thereby enhancing its market reach and confirming its role as an industry leader.