Item 8.01 Other Events.

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On January22, 2019,IRADIMED CORPORATION (the “Company”) issued a press release announcing 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 January17, 2019.

Our 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. Our 3880 MRI compatible patient vital signs monitoring system, originally cleared by UL and added to our EC Certificate in June2017, was recently subjected to such re-review.

On January16, 2019, we were 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 our 3880 patient vital signs monitoring system. This temporary EC Certificate will extend for six months, during which time we expect to cure the non-conformity and be permitted to again use the CE Mark on our 3880 patient vital signs monitoring system. In full compliance with this notification, we immediately suspended shipments of our 3880 patient vital signs monitor to all markets requiring a CE Mark.

Key points to note resulting from the notification and subsequent temporary suspension of shipments include:

· This action is not the result of safety, effectiveness or performance issues with our 3880 patient vital signs monitoring system.

· This action does not impact sales of our 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 our MRI compatible IV infusion pump and related accessories, disposables or services.

Forward-Looking Statements

This Current Report on Form8-K includes forward-looking statements as defined in the Private Securities Litigation Act of 1995, particularly statements regarding our expectations, beliefs, plans, intentions, future operations, financial condition and prospects, and business strategies. These statements relate to future events or our future financial performance or condition and involve unknown risks, uncertainties and other factors that could cause our actual results, level of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements. The risks and uncertainties referred to above include, but are not limited to, risks associated with the Company’s ability to receive an EC Certificate or CE Mark for our existing products, receive FDA 510(k)clearance for new products; unexpected costs, delays or diversion of management’s attention associated with the design, manufacture or sale of new products; the Company’s ability to implement successful sales techniques for existing and future products and evaluate the effectiveness of its sales techniques; additional actions by or requests from the FDA; our significant reliance on a single product; unexpected costs, expenses and diversion of management attention resulting from the FDA warning letter; potential disruptions in our limited supply chain for our products; a reduction in international distribution; actions of the FDA or other regulatory bodies that could delay, limit or suspend product development, manufacturing or sales; the effect of recalls, patient adverse events or deaths on our business; difficulties or delays in the development, production, manufacturing and marketing of new or existing products and services; changes in laws and regulations or in the interpretation or application of laws or regulations.

Further information on these and other factors that could affect the Company’s financial results is included in filings we make with the Securities and Exchange Commission from time to time. All forward-looking statements are based on information available to us on the date hereof, and we assume no obligation to update forward-looking statements.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits




Press Release dated January22, 2019

EX-99.1 2 a19-3235_1ex99d1.htm EX-99.1 Exhibit 99.1     IRADIMED CORPORATION Expects Minor Impact to 2019 Revenue After Temporarily Suspending Shipments of MRI Compatible Patient Vital Signs Monitoring Systems in European Markets   ·                  Action being taken after CE mark expiration ·                  Expects negative impact to full-year 2019 revenue of approximately two percent   Winter Springs,…
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IRADIMED CORPORATION (IRADIMED) develops, manufactures, markets and distributes Magnetic Resonance Imaging (MRI) compatible products, and provides non-magnetic intravenous (IV) infusion pump systems. The Company operates through development, manufacture and sale of MRI compatible products and IV infusion pump systems for use by hospitals and acute care facilities during MRI procedures segment. Its MRidium MRI compatible IV infusion pump system has been designed with a non-magnetic ultrasonic motor, non-ferrous part and other features in order to deliver anesthesia and other IV fluids during various MRI procedures. MRI compatible IV infusion pump system includes the 3860+ MRI compatible IV infusion pump, single-use IV tubing sets, a non-magnetic pole and a lithium battery. In addition, it offers optional upgrade systems, including the 3865 Remote Display/Control, 3861 Side Car, Dose Error Reduction System (DERS) and SpO2 monitor.

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