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CraniUS Therapeutics Wins FDA Clearance for Its First Commercial Product, the CraniUS Plate

PRNewswire · September 9, 2026

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The FDA has cleared CraniUS Therapeutics' first product for sale in the US: the CraniUS Plate, a cranioplasty implant custom-made per patient to fix defects in the skull. Internally designated NeuroPASS 1, the plate is essentially the base hardware layer…

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