MRI accessories developer IRadimed has temporarily suspended shipments of its 3880 MRI-compatible patient vital signs monitoring systems in European markets following the expiration of its CE Mark on January 17.
After a routine recertification process, European regulatory body UL International informed IRadimed that its recent technical file review of the 3880 system could not be completed, as aspects of clinical evaluation reporting -- required by newly issued guidance from the European Union -- were unacceptable. As a result of this technical nonconformity, UL has issued a temporary European Commission (EC) certificate that excludes the 3880 system.
IRadimed said it expects to fix the nonconformity during the six-month period of the temporary EC certificate and to be permitted to use the CE Mark on its 3880 system. In the meantime, however, IRadimed has stopped offering 3880 systems to all markets that require a CE Mark.
The firm said this action will reduce 2019 revenue by 2%. However, it still anticipates 20% revenue growth in 2019.
