CraniUS announces NeuroPASS 2 cranial plate clearance and NeuroPASS 3 drug-delivery patent
Published in Brain/Neurology, Tools.
October 7, 2026
CraniUS Therapeutics announced FDA 510(k) clearance for its NeuroPASS 2 cranial plate configuration and a U.S. patent covering the architecture of its investigational NeuroPASS 3 drug-delivery program.
The NeuroPASS 2 clearance was issued on September 11, 2026. It covers a patient-specific PEEK implant for cranial bone defects in adults aged 22 and older. The configuration adds an opening designed to accommodate an intracranial pressure sensor; sensors and monitoring functions are outside the clearance.
The patent, announced as issued on October 7, describes an implant integrating a refillable reservoir, pump and catheters to deliver therapeutic fluid to a brain target. CraniUS is completing preclinical work and targets a first-in-human NeuroPASS 3 study in the second quarter of 2027.
NeuroPASS 3 has not been FDA cleared or approved and is unavailable for sale. A patent establishes intellectual-property protection, not clinical safety or effectiveness. The cleared plate should therefore be distinguished from the proposed drug-delivery system.