Iradimed wins FDA nod for MR-compatible patient monitoring system

iRadimed (NSDQ:IRMD) said today that it won 510(k) clearance from the FDA for its 3880 MR-compatible patient monitoring system.
The 3880 device is designed to allow patients to be transported from critical care units for magnetic resonance imaging scans without interruption to vital signs monitoring. Winter Springs, Fla.-based Iradimed claims it as the smallest and most-portable MRI monitor on the U.S. market.
“We are excited to announce receipt of FDA 510(k) clearance and launch our revolutionary MRI-compatible patient vital signs monitoring system to U.S. customers,” president & CEO Roger Susi said in prepared remarks. “It has an easy-to-use design and unique wireless tablet remote control that allows for the effective communication of vital signs information to clinicians.
“With the 3880 monitor’s record setting 30,000 gauss rating, non-magnetic design, small form factor and optional tablet that allows for the remote viewing of patient vital signs and control of the monitoring unit from the MRI control room, the Iradimed 3880 brings a unique and fresh solution to the MRI patient monitoring market,” Susi added.
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Source: Mass Device - October 26, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Imaging Patient Monitoring Regulatory/Compliance Iradimed Corp Source Type: news