IRADIMED CORPORATION (NASDAQ:IRMD) Files An 8-K Other Events
Item 8.01 Other Events.
Winter Springs, Florida, October 8, 2019 IRADIMED CORPORATION (NASDAQ: IRMD), today announced that it received a close-out letter from the U.S. Food and Drug Administration resolving all issues cited in the August 2014 warning letter.
The resolution of the warning letter is the result of countless hours of work performed by everyone at IRADIMED. We are thankful for these efforts and the collective commitment to continuously improve our quality management system, said Leslie McDonnell, President and Chief Executive Officer of the Company.
The Company does not expect a significant impact to its business or financial performance resulting from the close-out letter.
This press release contains 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 Companys 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 managements attention associated with the design, manufacture or sale of new products; the Companys ability to implement successful sales techniques for existing and future products and evaluate the effectiveness of its sales techniques; additional actions, warnings or requests from the FDA; our significant reliance on a single product; 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 Companys 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.