IRADIMED CORPORATION announced that it temporarily suspended sales of its 3880 MRI compatible patient vital signs monitoring systems in European Commission (“EC”) markets due to the expiration of its CE Mark on January 17, 2019. Products are regulated in Europe by the U.K. Notified Body, UL International Ltd. (“UL”), 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. 3880 MRI compatible patient vital signs monitoring system, originally cleared by UL and added to EC Certificate in June 2017, was recently subjected to such re-review. On January 16, 2019, the company was notified by UL that their recent technical file review of 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 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 3880 patient vital signs monitoring system. In full compliance with this notification, the company immediately suspended shipments of 3880 patient vital signs monitor to all markets requiring a CE Mark.

The company expects this action may reduce full-year 2019 revenue by approximately 2%. After considering this impact, the company still expects mid 20% revenue growth in 2019.