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Medical Devices / Submissions and Approvals

FDA Clears Ivenix’s Infusion Pump System

June 12, 2019

The FDA granted Ivenix 510(k) clearance for its Ivenix Infusion System, a large-volume pump and infusion system for the administration of IV drugs.

The device was designed to meet agency guidelines on infusion pumps. The guidelines, revised in 2014, require additional safety information in premarket submissions, such as detailed information on the device’s engineering and more details of the steps taken to reduce risks.

The infusion pump comes with a smartphone-like interface and pumping technology that tracks flow to ensure accuracy. The system can also predict and prevent critical use errors.

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