Medtronic and ClaroNav receive key regulatory approvals for surgical navigation

Medtronic has received FDA 510(k) clearance for its ApexCut EM navigation blades, designed for use with its Stealth-AXiS-ENT system during sinus surgeries. The technology integrates powered surgical tools directly with navigation capabilities to provide more precise guidance for surgeons. Clinical use in the United States is expected to begin in 2026, pending the release of an updated navigation software version.

Separately, Toronto-based ClaroNav Kolahi Inc. has announced that its Navient surgical navigation system has achieved certification under the European Medical Device Regulation (EU-MDR). This certification allows the company to continue offering the Navient system and its reusable instruments in the European market, transitioning from the previous EU MDD standards. The Navient platform utilizes optical tracking, image integration, and AI-supported surgical planning for procedures involving the spine, cranium, ENT, and biopsies.