Medtronic wins FDA clearance for ApexCut EM navigated sinus surgery blades
MDT•Medtronic received FDA 510(k) clearance for ApexCut EM navigated sinus surgery blades, which connect to its Stealth AXiS ENT navigation system. First U.S. clinical cases are expected later this year, pending updated navigation software.
1. Clearance and launch
Medtronic received FDA 510(k) clearance for ApexCut EM navigated blades for sinus surgery. The blades connect directly to the Stealth AXiS ENT navigation system, adding navigated capability to the company's powered ENT instruments portfolio. First U.S. clinical cases are expected later this year, pending release of updated navigation software.
