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OcuMet Beacon granted clearance by FDA

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Key Takeaways

  • OcuMet Beacon, a noninvasive retinal health assessment tool, has received FDA clearance for US market entry.
  • The device uses proprietary technology for IR and AF imaging, capturing natural eye fluorescence without injections or dyes.
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The OcuMet Beacon is a proprietary, noninvasive tool for assessing retinal health. The company said it will be available on the US market for use in clinics and healthcare institutions.

(Image Credit: AdobeStock/derren)

(Image Credit: AdobeStock/derren)

The US Food and Drug Administration (FDA) has granted clearance for OcuSciences, Inc.’s flagship device, OcuMet Beacon, the company announced in a press release.1 The company said it will soon be available on the US market for use in clinics and healthcare institutions across the United States.

OcuMet Beacon is a tool for assessing retinal health. Capturing a naturally occurring fluorescence from the eye using proprietary illumination and detection technology, OcuMet Beacon is indicated for ophthalmoscope scanning for infrared (IR) and autofluorescence (AF) imaging of a human retina with or without the use of a mydriatic agent. The technology of the OcuMet Beacon is noninvasive, requiring no injections, dyes, or physical contact with the eye.

“With our collaborators, we are extending the depth of understanding for retinal diseases,” said Kurt Riegger, chief executive officer of OcuSciences. “This is a game-changer for the many patients and ophthalmologists who stand to benefit from more precise and deeper insight.”1

The safety and clinical utility of the OcuMet Beacon are demonstrated and documented in an extensive set of peer-reviewed clinical studies and a dozen new studies to be presented at ARVO, expanding the clinical use of the tool.

References:
  1. OcuSciences announces FDA marketing clearance of OcuMet Beacon in retinal health assessment at ARVO. Published May 1, 2025. Accessed May 1, 2025. https://www.businesswire.com/news/home/20250501118944/en/OcuSciences-Announces-FDA-Marketing-Clearance-of-OcuMet-Beacon-in-Retinal-Health-Assessment-at-ARVO?

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