“We are very pleased with obtaining the CE mark renewal certificate for our patient monitors. With the renewed certificate, we are immediately resuming shipments to the impacted customers and thank them for their patience,” president and CEO Leslie McDonnell said in a news release.
Winter Springs, Fla.-based Iradimed halted sales of its 3880 MRI-compatible vital signs monitor in the European Union in January this year. The expiration came after the UL International notified body reviewed its technical file and found that it ran afoul of new EU clinical evaluation rules.
Iradimed’s 3880 MRI-compatible patient vital signs monitoring systems are designed with non-magnetic components and other special features to allow for clinicians to safely and accurately monitor a patient’s vital signs during MRI procedures. It can operate in magnetic fields up to 30,000 gauss and has a compact, lightweight design that can travel with the patient from their critical care unit to the MRI.