Terumo Cardiovascular announces US FDA 510(K) clearance for CDI OneView monitoring system

Terumo Cardiovascular, a global leader in cardiovascular surgery technologies, has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the CDI OneView Monitoring System. The next-generation CDI Systems platform provides visibility of key patient parameters during cardiopulmonary bypass surgery, critical to perfusion safety and improving patient outcomes.

The new CDI OneView System measures or displays up to 22 key parameters, the newest of which are measured flow (Q), cardiac index (CI), regional cerebral oxygen saturation (rSO₂), oxygen extraction ratio (O₂ER), Area Under the DO₂ Curve (AUC), and measured arterial oxygen saturation (SaO₂).  In response to the growing needs of healthcare providers, the new CDI OneView System now provides real-time O₂ER, CI, VO₂ and DO₂ information to help perfusionists maintain a safe threshold for those parameters. Independently published and reviewed clinical research indicates that maintaining optimal levels during cardiopulmonary bypass can help to reduce the incidence of acute kidney injury.

This innovative system offers maximum configurability and flexibility in how the parameters can be viewed and prioritized to best suit clinical needs and preferences, while continuing to provide the reliable critical information for clinicians.

Robert DeRyke, President and CEO of Terumo Cardiovascular said, “The CDI OneView System technology is the latest extension of Terumo's commitment to delivering data-focused solutions to the perfusion community."