FDA clears iRadimed MRI infusion system
The FDA has granted IRadimed 510(k) clearance of its MRidium 3860+MRI infusion system with integrated Masimo Set SpO2 monitoring.
The system is designed to address the need of those patients who rely on infusion therapy, but who also rely on MRI for diagnosis and treatment. According to Winter Park, Fla.-based IRadimed, putting IV and monitoring equipment in an MR environment can result in the equipment causing artifacts on the images, becoming unreliable during crucial deliveries of medications and monitoring, or shutting down. Also, improper pulse oximeters can result in severe patient burn.
The MRidium system is designed to operate right next to the bore of the MRI, and deliver medications while being monitored remotely from outside the MRI room, so physicians can make adjustments without stopping the scan, the company said.
The system is designed to address the need of those patients who rely on infusion therapy, but who also rely on MRI for diagnosis and treatment. According to Winter Park, Fla.-based IRadimed, putting IV and monitoring equipment in an MR environment can result in the equipment causing artifacts on the images, becoming unreliable during crucial deliveries of medications and monitoring, or shutting down. Also, improper pulse oximeters can result in severe patient burn.
The MRidium system is designed to operate right next to the bore of the MRI, and deliver medications while being monitored remotely from outside the MRI room, so physicians can make adjustments without stopping the scan, the company said.