FDA Grants Clearance for OcuMet Beacon Retinal Imaging Device

FDA批准OcuMet Beacon视网膜成像设备的使用

May 06, 2025

2025年5月6日

OcuSciences, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted regulatory clearance for its flagship diagnostic device, the OcuMet Beacon. According to the company’s press release, the device will soon become available for clinical use across healthcare institutions in the United States..

OcuSciences公司宣布，美国食品药品监督管理局（FDA）已为其旗舰诊断设备OcuMet Beacon授予了监管许可。根据公司的新闻稿，该设备将很快在美国的医疗机构中投入临床使用。

Overview of OcuMet Beacon’s Retinal Imaging Capabilities

OcuMet Beacon视网膜成像功能概述

The OcuMet Beacon is designed to assess retinal health by detecting naturally occurring autofluorescence (AF) and infrared (IR) signals from the human retina. Utilizing proprietary illumination and detection technology, the system enables noninvasive retinal imaging without the need for injections, dyes, or direct physical contact with the eye..

OcuMet Beacon 旨在通过检测人类视网膜中自然产生的自发荧光 (AF) 和红外 (IR) 信号来评估视网膜健康状况。该系统利用专有的照明和检测技术，无需注射、染料或与眼睛直接接触即可实现无创的视网膜成像。

The device is FDA-cleared for ophthalmoscope scanning of the retina with or without the use of a mydriatic agent, supporting both IR and AF imaging modes.

该设备已获FDA批准，可进行视网膜的眼底镜扫描，无论是否使用散瞳剂，且支持红外和自发荧光成像模式。

Kurt Riegger, CEO of OcuSciences, emphasized the potential of the device:

OcuSciences首席执行官库尔特·里格强调了该设备的潜力：

“With our collaborators, we are extending the depth of understanding for retinal diseases. This is a game-changer for the many patients and ophthalmologists who stand to benefit from more precise and deeper insight.”

“通过与我们的合作者共同努力，我们正在加深对视网膜疾病的理解。这一进展将为众多患者和眼科医生带来更精确和深入的认识，是一项改变局面的突破。”

Clinical Validation and Upcoming Research Presentations

临床验证与即将进行的研究报告

The safety and clinical utility of the OcuMet Beacon have been demonstrated in a broad body of peer-reviewed clinical studies. In addition, the company confirmed that 12 new clinical studies showcasing expanded applications of the device will be presented at the upcoming Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting..

OcuMet Beacon 的安全性和临床实用性已在大量经同行评议的临床研究中得到证实。此外，该公司确认将在即将召开的 2025 年视觉与眼科研究协会 (ARVO) 年会上展示 12 项新的临床研究，重点介绍该设备的扩展应用。

These developments position OcuMet Beacon as a novel diagnostic solution poised to enhance retinal disease evaluation and management across clinical settings.

这些进展使OcuMet Beacon成为一种新型诊断解决方案，有望提升各种临床环境中的视网膜疾病评估与管理。