Terumo Cardiovascular Obtains FDA 510(K) Clearance for CDI OneView™ Monitoring System

Tuesday, May 28, 2024

Terumo Cardiovascular, a leader in cardiovascular surgery technologies, has received FDA clearance for its CDI OneView Monitoring System.

This system, designed for cardiopulmonary bypass surgery, provides visibility into key patient parameters crucial for perfusion safety and improved outcomes.

The CDI OneView System can measure or display up to 22 parameters, including 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).

This system offers flexibility in parameter viewing and prioritization to meet clinical needs while delivering essential information.

President and CEO of Terumo Cardiovascular, highlights the company's commitment to enhancing patient care through data-focused solutions.

The CDI OneView System's development incorporated feedback from perfusionists worldwide, aiming to address evolving healthcare needs.

Real-time data on parameters like O2ER and CI can aid in maintaining safe thresholds, potentially reducing acute kidney injury during cardiopulmonary bypass.

 

 

 

 

Source:prnewswire.com