ClearPoint Neuro (NASDAQ:CLPT) obtained a Health Canada Medical Device License for its Neuro Navigation System on 21‑Apr‑2026.
Approval covers both MRI‑guidance and iCT‑guidance workflows, complementing the SmartFlow Neuro Cannula clearance granted in Oct 2025.
The clearance enables Canadian neurosurgery centers and biopharma partners to run clinical trials and commercial sites using the same platform as the U.S.
Company aims to support up to 20,000 annual cell and gene therapy procedures, expanding its regulatory network to 34 countries.