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Home » Zilia earns FDA clearance for retinal camera

Zilia earns FDA clearance for retinal camera

November 29, 2023 By Sean Whooley

Zilia Ocular FC retinal camera co-founders Patrick Sauvageau and Dominic Sauvageau
Co-founders Patrick Sauvageau and Dominic Sauvageau with the Ocular FC. [Image courtesy of Zilia]
Zilia announced today that it received FDA 510(k) clearance for its Ocular FC retinal camera for non-invasive ocular assessments.

Quebec City, Canada-based Zilia designed the Ocular FC system for assessing ocular biomarkers. The company believes it could “transform the diagnosis and management of ocular diseases,” according to a news release. It said the FDA clearance marks a “pivotal moment” in the company’s growth.

The first-of-its-kind technology integrates advanced photonics and artificial intelligence (AI). This aims to leverage the eye’s optical properties and direct connections to the vascular system and the brain. According to Zilia, this could help to capture critical information both on ocular and overall health.

This technology harnesses imaging, spectrometry, and artificial intelligence to detect and measure biomarkers in the eye. The company says Zilia Ocular paves the way to advance the investigation into metabolic responses and pathophysiologies of the eye and the brain.

Dr. Patrick Sauvageau, optometrist, CEO, and co-founder of Zilia, said FDA clearance represents more than “just a milestone.”

“It’s a leap forward in our quest to safeguard the vision of millions,” Sauvageau said. “We’re now focused on obtaining De Novo classification for ocular oximetry, a breakthrough biomarker that promises to revolutionize how we diagnose and manage a variety of ocular conditions.”

Filed Under: 510(k), Diagnostics, Food & Drug Administration (FDA), Imaging, Optical/Ophthalmic, Regulatory/Compliance, Vision Tagged With: Zilia

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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