Tag: clears

FDA clears Topcon’s OMNIA auto kerato-refracto tonometer
Eye Healthcare

FDA clears Topcon’s OMNIA auto kerato-refracto tonometer

November 24, 2025
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Topcon Healthcare, Inc. announced the simultaneous FDA 510(k) clearance—and U.S. commercial launch—of OMNIA, a fully automated…

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FDA clears Sora Neuroscience’s brain mapping software
Brain Healthcare

FDA clears Sora Neuroscience’s brain mapping software

June 28, 2025
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Sora Neuroscience, a brain AI software company, announced it received FDA clearance for its Cirrus brain…

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FDA clears Hyperfine’s Optive AI software for brain imaging
Brain Healthcare

FDA clears Hyperfine’s Optive AI software for brain imaging

May 30, 2025
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Healthcare technology company Hyperfine announced that the FDA cleared its Optive AI software for its Swoop…

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