Teleflex has received 510(k) clearance from the US Food and Drug Administration (FDA) for the MR Conditional labelling of the Arrow EZ-IO Needle.
The labelling approval indicates that the needle can be used in a magnetic resonance imaging (MRI) environment.
The EZ-IO Needle is a key part of Teleflex’s Arrow EZ-IO Intraosseous Vascular Access System. It features a patented diamond tip that enables rapid, accurate and steady insertion.
Teleflex anaesthesia and emergency medicine general manager and president Kevin Robinson said: “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.”
The EZ-IO system serves as a viable solution when it is hard to get intravenous access in urgent, emergency or medically necessary cases.
The MR Conditional labelling enables clinicians to provide uninterrupted care to patients in need of MRI scans, without disturbing the existing site for vascular access.
Teleflex corporate vice-president and chief medical officer Michelle Fox said: “Clinical and Medical Affairs is committed to supporting the expanded use of Teleflex medical devices in a continuous effort to improve patient care.
“Patients who require emergent or urgent MRI now have an additional vascular access option.”