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Zilia旗下Zilia Ocular ™FC视网膜相机获批FDA 510(K)

Zilia Receives FDA Clearance for its Zilia Ocular™ FC Retinal Camera

PR Newswire 等信源发布 2023-11-29 21:15

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QUEBEC CITY, Nov. 29, 2023 /PRNewswire/ - Zilia, a medical technology company specializing in the non-invasive assessment of ocular biomarkers, announced today a significant advancement in the deployment of its groundbreaking technology set to transform the diagnosis and management of ocular diseases.Zilia's innovative retinal camera, the Zilia Ocular FC, has received 510(k) clearance from the U.S.

魁北克市,2023年11月29日/PRNewswire/-Zilia,一家专门从事眼部生物标志物无创评估的医疗技术公司,今天宣布部署其开创性技术取得重大进展,旨在改变眼部疾病的诊断和管理。Zilia的创新视网膜相机Zilia Ocular FC已获得美国510(k)的许可。

Food and Drug Administration (FDA), marking a pivotal moment in the company's growth..

食品药品监督管理局(FDA),标志着公司发展的关键时刻。。

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Co-founders Patrick Sauvageau, CEO and Dominic Sauvageau, CTO with the Zilia Ocular FC. (CNW Group/Zilia)

联合创始人Patrick Sauvageau,首席执行官和Dominic Sauvageau,Zilia Ocular FC的首席技术官。(CNW集团/Zilia)

'Receiving this first FDA clearance for our retinal camera is not just a milestone, it's a leap forward in our quest to safeguard the vision of millions,' said Dr. Patrick Sauvageau, optometrist, CEO, and co-founder of Zilia. '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.'.

Zilia首席执行官兼联合创始人Patrick Sauvageau博士说:“接受我们的视网膜照相机首次获得FDA批准不仅仅是一个里程碑,这是我们寻求保护数百万人视力的飞跃。”我们现在专注于获得眼血氧饱和度的从头分类,这是一种突破性的生物标志物,有望彻底改变我们如何诊断和管理各种眼部疾病。

About Zilia

关于Zilia

Zilia is a medical technology company developing a groundbreaking platform to non-invasively measure biomarkers in the eye, with an initial focus on ocular oximetry. By integrating advanced photonics and artificial intelligence, Zilia's first-of-kind technology is intended to leverage the eye's optical properties and its direct connections to the vascular system and the brain, capturing critical information on ocular and overall health.For further information: https://ziliahealth.comSOURCE Zilia.

Zilia是一家医疗技术公司,开发了一个开创性的平台,可以非侵入性地测量眼睛中的生物标志物,最初专注于眼血氧测定。通过整合先进的光子学和人工智能,Zilia的首创技术旨在利用眼睛的光学特性及其与血管系统和大脑的直接连接,捕捉有关眼部和整体健康的关键信息。欲了解更多信息:https://ziliahealth.comsource齐利亚。