Teleflex (NYSE:TFX) announced today that it received FDA 510(k) clearance for its Arrow EZ-IO needle for MR conditional labeling.
Wayne, Pennsylvania-based Teleflex said the regulatory nod makes the needle the first and only intraosseous needle with 510(k) clearance.
The EZ-IO needle represents a critical component of Teleflex’s Arrow EZ-IO intraosseous vascular access system. It features a patented diamond tip for fast, precise and steady insertion. The system can be used when intravenous access is difficult or impossible to obtain in emergent, urgent or medically necessary cases.
New labeling enables the clinician to care for patients requiring MRI scans without interrupting the established vascular access site. Michelle Fox, Teleflex VP and chief medical officer, said it provides an additional vascular access option for those requiring MRI.
“Teleflex continues to innovate on behalf of clinicians who are seeking to provide continuous care during critical situations. We are excited to have the Arrow EZ-IO needle cleared as MR conditional and look forward to finding new ways to deliver outstanding care solutions for patients and providers,” said Kevin Robinson, president and GM, anesthesia and emergency medicine, Teleflex.