IRADIMED CORPORATION Expects Minor Impact to 2019 Revenue After Temporarily Suspending Shipments of MRI Compatible Patient Vital Signs Monitoring Systems in European Markets; Provides Revenue Guidance for 2019
January 22, 2019 at 07:00 am EST
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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.
IRadimed Corporation develops, manufactures, markets and distributes magnetic resonance imaging (MRI) compatible medical devices and accessories and services. Its MRidium 3860+ MRI Compatible IV infusion pump system provides non-magnetic Intravenous (IV) infusion pump system that is specifically designed for safe use during MRI procedures. Its MRidium MRI compatible IV infusion pump system has been designed with a non-magnetic ultrasonic motor with non-ferrous parts and other special features to deliver anesthesia safely and predictably and other IV medications or fluids during various MRI procedures. Its IRadimed 3880 MRI Compatible patient vital signs monitoring system has been designed with non-magnetic components and other features to monitor a patientâs vital signs safely and accurately during various MRI procedures. The Company sells its products primarily to hospitals and acute care facilities. The IRADIMED 3880 system operates dependably in magnetic fields up to 30,000 gausses.
IRADIMED CORPORATION Expects Minor Impact to 2019 Revenue After Temporarily Suspending Shipments of MRI Compatible Patient Vital Signs Monitoring Systems in European Markets; Provides Revenue Guidance for 2019