CraniUS Therapeutics Receives FDA 510(k) Clearance for the CraniUS® Plate, a Patient-Specific Cranial Implant

<p>Clearance establishes the company's first product for the U.S. market and the foundation of its investigational NeuroPASS™ platform. BALTIMORE, Sept. 9, 2026 /PRNewswire/ -- CraniUS Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance...</p>