FDA Approves World’s First Non-Magnetic MRI Monitor
Thinly traded micro cap iRadimed has now announced 510(k) clearance from the FDA for its 3880 MR-compatible patient monitoring system.
The compact non-magnetic monitor can be used to transport patients from critical care departments of hospitals to the MRI scanner room and back to critical care without an interruption in vital signs monitoring.
The company says the 3880 is the smallest and most portable MRI monitor on the market and can be used virtually anywhere in the MRI scanner room.
“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. The Iradimed 3880 monitor’s compact non-magnetic design positions Iradimed as the only company in the world with an MRI compatible patient monitor that can be used to transport patients from the critical care departments of hospitals to the MRI scanner room and back to critical care without an interruption in vital signs monitoring. 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,” said Roger Susi, President and Chief Executive Officer of the Company.
“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,
” said Susi.The features of the IRADIMED 3880 include wireless ECG with dynamic gradient filtering; wireless SpO2 using Masimo® algorithms; respiratory CO2; non-invasive blood pressure; patient temperature, and; optional advanced multi-gas anesthetic agent unit featuring continuous Minimum Alveolar Concentration measurements.
