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Terumo wins FDA 510(k) for next-gen bypass surgery monitoring

Terumo Cardiovascular today announced FDA 510(k) clearance of its next-generation CDI OneView monitoring system.

Terumo’s CDI systems display patient parameters during cardiopulmonary bypass surgery in order to support perfusion safety and improve patient outcomes.

According to the company, the new CDI OneView system measures or displays up to 22 vital patient parameters — including oxygen delivery, cardiac index, area under the indexed oxygen delivery curve, oxygen extraction ratio and measured flow.

The goal of the new system’s design was to provide maximum configurability and flexibility in how the parameters can be viewed and prioritized, according to Terumo. At the same time, it was also important to ensure the system continued to provide the critical information on which clinicians rely.

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