Eidam Responds to FDA Correspondence
Eidam Diagnostics Corporation revises marketing materials to ensure compliance with US Food and Drug Administration requirements
Richmond, BC – August 13, 2007
Eidam Diagnostics Corporation received a Warning Letter dated July 26, 2007 from the United States FDA. The FDA reviewed information on www.eidam.com, and identified marketing statements that did not meet regulatory requirements for a Class 1 510(k) cleared Medical Device. Eidam has responded to the FDA.
Action was taken to remedy the website and related marketing media: a completely revised website was released on August 2, 2007, intended to meet FDA regulations and also improve overall marketing communications. In addition, Eidam has also implemented corrective actions to ensure future marketing communications are reviewed for regulatory compliance before release to the public.
About Eidam Diagnostics Corporation
Eidam Diagnostics Corporation is a privately held Canadian company headquartered in Richmond, British Columbia, with offices in German and China.
The company's primary product, the CRT 2000® Thermographic System is intended for use in preventative healthcare, and is able to detect the changes in the body's temperature regulation to produce data that can be used for adjunctive diagnosis of certain diseases.
The CRT 2000® is the only contact thermography device of its kind in the world. It is non-invasive, emits no radiation, and can be used repeatedly for treatment monitoring.
The CRT 2000® has obtained CE accreditation and has been listed as a US FDA 510(k) Class I medical device.
Eidam aims to prevent the progression of disease, by identifying the initial development of illnesses before symptoms manifest.
For more information about Eidam Diagnostics Corporation, please contact Shelley Leonhardt, Senior Vice President, at (604) 304-6016 or visit our website at www.eidam.com.