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.
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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.
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By GlobalDataThe 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.”
