FDA clears IRadimed's MRI-compatible pump

MRI accessories developer IRadimed has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its MRidium 3860+ MRI-compatible IV infusion pump system, including its Dose Error Reduction System (DERS) software.

The pump provides fluid delivery before, during, and after an MRI scan. The DERS software incorporates dosing safety features for patients, and it enables users to create a drug library and establish nominal values and limits for dose and concentration for specified infusion protocols. There are also user-programmed infusion hard limits (maximum and minimum) and soft limits (high and low limits that require user confirmation to exceed).

Page 1 of 611
Next Page