Wire · opportunities
CraniUS Therapeutics Receives FDA 510(k) Clearance for the CraniUS® Plate, a Patient ...
◆ Sectors
◆ Geography
◆ Source
◆ Verified
Fusion42 · 10 September 2026 · Fusion42 review
CraniUS Therapeutics has received FDA 510(k) clearance for its patient-specific CraniUS Plate, enabling the company to market its first product in the U.S. This implant serves as the foundation for the company's NeuroPASS platform aimed at advanced cranial implants with future capabilities like brain access, diagnostics, and drug delivery.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
You have a new, FDA-cleared way to offer surgeons patient-specific cranial implants today while preparing to add diagnostics and drug delivery to the same platform. This clearance opens the door to capturing surgical market share before competitors develop similar advanced cranial implant features.
◆ Coverage
1 source · 9 Sep 2026
◆ Related on Wire
◆ Topics