CeriBell (CBLL) announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation for its Large Vessel Occlusion stroke detection monitor for patients in the hospital setting. The Breakthrough Device Designation for LVO Stroke builds on recent FDA 510(k) clearances for its next-generation Clarity algorithm to detect electrographic seizures in neonates and its proprietary delirium screening and monitoring solution, the company said.
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