FDA clears Terumo’s CDI blood oxygen monitor

Terumo has received FDA 510(k) clearance for its CDI Blood Parameter Monitoring System 550, which adds real-time oxygen delivery monitoring to its 12 critical blood parameters.

Oxygen delivery measurements show how much oxygen is being delivered to a patient during a cardiopulmonary bypass. The company suggests that monitoring oxygen delivery has shown to reduce acute kidney injuries, which is a common complication of cardiac surgery.

“For more than 30 years, Terumo’s CDI Systems have been the most trusted and used continuous in-line blood gas monitors for critical blood parameters,” Robert DeRyke, president and CEO of Terumo Cardiovascular, said in a press release. “We are continuing to develop monitoring technologies for the cardiac OR – and beyond – that will improve patient outcomes and result in meaningful value for our customers.”

Terumo’s new CDI System 550 measures and calculates pH, pCO2, pO2, K+, temperature, SO2, hematocrit, hemoglobin, base excess, bicarbonate, oxygen consumption and oxygen delivery. The system also offers optical fluorescence technology, a high-visibility LCD screen, advanced probe design and IEC 60601-1 third edition compliance.