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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.