Saturday, June 22, 2024

Monitoring System: FDA Grants Approval to Terumo’s CDI OneView

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Monitoring system for Terumo Cardiovascular’s CDI OneView has been granted  by The US Food and Drug Administration (FDA) is a cutting-edge device designed to enhance patient monitoring during cardiopulmonary bypass surgery. This advanced system aims to provide critical visibility of patient parameters, which is essential for ensuring perfusion safety and improving patient outcomes during surgery.

The CDI OneView System is equipped to measure or display up to 22 vital patient 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). The system’s configurability and flexibility allow clinicians to tailor the display of parameters to their specific clinical needs and preferences while maintaining access to essential patient information.

Terumo has developed the CDI OneView System by incorporating feedback from perfusionists at cardiovascular institutions worldwide. This collaboration has led to significant advancements, particularly in 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, ensuring optimal patient care.

Robert DeRyke, president and CEO of Terumo Cardiovascular, highlighted the importance of the new system: “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. The company’s focus on innovation and quality has made it a leader in the medical device industry, particularly in the field of cardiovascular care.

Monitoring System

CDI OneView  Marks Milestone in Terumo Cardiovascular’s Commitment to Advanced Surgical Technology

The development of the CDI OneView System represents a significant milestone for Terumo Cardiovascular, reflecting its dedication to improving patient outcomes through advanced technology. The system’s ability to monitor a comprehensive range of parameters in real-time provides perfusionists with the necessary tools to make informed decisions during surgery, thereby enhancing the safety and effectiveness of cardiopulmonary bypass procedures.

The CDI OneView System’s approval by the FDA underscores the importance of continuous innovation in the medical field, particularly in the development of technologies that improve patient care. By providing clinicians with a robust and flexible monitoring system, Terumo Cardiovascular is setting new standards in the industry.

In addition to the CDI OneView System, Terumo Cardiovascular has been expanding its operations to meet the growing demand for advanced medical devices. Last September, the company announced the opening of its manufacturing plant in La Lima, Cartago, Costa Rica. This new facility is expected to play a crucial role in the production of high-quality medical devices, further supporting Terumo’s mission to enhance patient care globally.

The CDI OneView Monitoring System’s real-time data collection and comprehensive monitoring capabilities are expected to significantly impact the field of cardiopulmonary bypass surgery. By offering detailed insights into patient parameters, the system enables clinicians to respond swiftly to any changes in the patient’s condition, thus improving overall outcomes.

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Overall, the FDA’s approval of Terumo’s CDI OneView Monitoring System marks a significant advancement in the field of cardiac surgery. With its ability to provide detailed and real-time monitoring of critical patient parameters, the system represents a major step forward in ensuring the safety and effectiveness of cardiopulmonary bypass procedures. Terumo Cardiovascular’s ongoing commitment to innovation and patient care continues to drive the development of groundbreaking technologies that enhance the quality of healthcare worldwide.

Resource: Prnewswire, May 28, 2024

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