iRadimed suspends sales of 3880 patient vital signs monitoring system

iRadimed announced that it temporarily suspended sales of its 3880 MRI compatible patient vital signs monitoring systems in European Commission, or EC, markets due to the expiration of its CE Mark on January 17. Products are regulated in Europe by the U.K. Notified Body, UL International, who provides certification allowing use of the CE Mark and permitting shipments of products into EC markets. Maintaining certification and use of the CE Mark requires manufacturers to routinely undergo periodic re-certification, which typically involves the re-review of a product technical file. The company’s 3880 MRI compatible patient vital signs monitoring system, originally cleared by UL and added to the EC Certificate in June 2017, was recently subjected to such re-review. On January 16, the company was notified by UL that their recent technical file review of our 3880 MRI compatible patient vital signs monitoring system could not be completed as aspects of clinical evaluation reporting, as required by newly issued guidance from the European Union, was not acceptable, resulting in a technical non-conformity. Accordingly, UL is issuing a temporary EC Certificate that excludes the company’s 3880 patient vital signs monitoring system. This temporary EC Certificate will extend for six months, during which time the company expects to cure the non-conformity and be permitted to again use the CE Mark on its 3880 patient vital signs monitoring system. In full compliance with this notification, iRadimed immediately suspended shipments of its 3880 patient vital signs monitor to all markets requiring a CE Mark. This action is not the result of safety, effectiveness or performance issues with the 3880 patient vital signs monitoring system. This action does not impact sales of 3880 patient vital signs monitoring system in the U.S. or in other markets that do not require a CE Mark for importation purposes. This action does not impact shipments of MRI compatible IV infusion pump and related accessories, disposables or services. “Despite the retrospective application of new guidance to our previously cleared 3380 MRI compatible patient vital signs monitoring system, we are fully cooperating and in direct discussions with UL to agree upon the necessary and proper application of the new guidance. We believe that data collection, documentation and UL’s review of the required information will take between three to four months, after which time we believe UL will renew the EC Certificate, once again permitting use of the CE Mark on our MRI compatible patient vital signs monitoring system. We expect to fully resolve this matter prior to the end of our second quarter,” said Roger Susi, president and CEO. “We expect this action may reduce full-year 2019 revenue by approximately two percent. After considering this impact, we still expect mid 20 percent revenue growth in 2019. We will provide our full-year 2019 revenue, GAAP and non-GAAP earnings guidance in our fourth quarter earnings release,” said Susi.

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