MetaMedical™ Solutions Inc

US FDA approves Terumo’s CDI OneView Monitoring System

Terumo’s CDI OneView System is designed to offer convenience for real-time decision making in the cardiovascular operating room. Credit: Terumo Cardiovascular/PRNewswire.com.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Terumo Cardiovascular’s CDI OneView Monitoring System, which aims to enhance patient monitoring during surgery.

The system is designed to provide critical visibility of patient parameters during cardiopulmonary bypass surgery. This is said to be critical to perfusion safety and enhancing patient outcomes.

The CDI OneView System is equipped to measure or display up to 22 parameters, including new additions such as measured flow (Q), regional cerebral oxygen saturation (rSO₂), oxygen extraction ratio (O₂ER), cardiac index (CI), Area Under the DO₂ Curve (AUC), and measured arterial oxygen saturation (SaO₂).

Furthermore, the system’s configurability and flexibility allow clinicians to tailor the display of parameters to their clinical needs and preferences while maintaining access to essential patient information.

Terumo said the development of the CDI OneView System incorporated feedback from perfusionists at cardiovascular institutions worldwide.

One of the significant advancements of the new system is the real-time monitoring of oxygen extraction ratio (O₂ER), CI, VO₂, and DO₂. These parameters are crucial for perfusionists to maintain safe thresholds during surgery.

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Terumo Cardiovascular president and CEO Robert DeRyke said: “With the launch of the new CDI OneView System, Terumo Cardiovascular continues to bring value and enhanced patient care to healthcare providers and critically ill cardiac patients.

“The CDI OneView System technology is the latest extension of Terumo’s commitment to delivering data-focused solutions to the perfusion community.”

Terumo Cardiovascular, a subsidiary of Japan’s Terumo, manufactures and markets medical devices for cardiac and vascular surgery.

Last September, the company announced the opening of its manufacturing plant in La Lima, Cartago, Costa Rica.


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