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FDA approves Rayner's RayOne Galaxy spiral IOL
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Fusion42 · 28 September 2026 · Fusion42 review
Rayner has received FDA approval for its RayOne Galaxy and RayOne Galaxy Toric, the first AI-developed spiral intraocular lenses (IOLs) platform, following positive safety and effectiveness data from a U.S. clinical trial. This approval enables the U.S. commercial launch of a product already cleared in 75 countries and implanted over 200,000 times internationally.
This Wire brief sits within Fusion42's coverage of Medtech.
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You now face a new market opening with an AI-designed spiral lens cleared by the FDA, requiring you to evaluate how this innovation changes patient outcomes and competitive products in vision correction.
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1 source · 28 Sep 2026
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