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Mortara Instrument Working With FDA, HL7, CDISC and Industry Participants to Finalize Proposed ECG Submission Standard

MILWAUKEE, Wis. USA,

25 March 2003

As the format for submission of ECG data collected in clinical trials to the FDA progresses, Mortara Instrument is serving to harmonize the efforts of the Agency, HL7, CDISC and industry participants.   The format’s principal architect, Barry Brown of Mortara Instrument, has spent a great deal of time and effort in working with all of the groups mentioned to review and receive input that will assure the success of the format when it is implemented.

Brown, Product Integration Manager at Mortara Instrument, commented “We’ve made some important progress in the last few months. An annotated ECG Message went to HL7 membership ballot on March 10th for a 30 day comment period. The FDA should be issuing a federal registry notice pointing the public to the HL7 materials for a public 30 day comment period, and the feedback will be discussed and acted upon at the next HL7 working group meeting, scheduled for April 28th - May 2nd of 2003. Depending on the nature of feedback, the FDA could start requesting ECG submissions for new trials as early as Q3 2003.”

To facilitate awareness, Mortara Instrument has dedicated a section of its website to information regarding the history and emerging progress of the FDA initiative at: www.mortara.com\Research_Proposed ECG Interchange Standards  Mark Mentzer, Director of Sales and Marketing, added, “We have received a great deal of interest in our participation in the process, and Mortara Instrument feels it is important to serve not only in a technical, but also an informational capacity to keep the entire community of interested parties as up to date as we can as to the progress, since the November 19^th 2001 meeting, that has been made on the emerging format.”

About Mortara Instrument

David W. Mortara, Ph.D., one of the world’s leading figures in ECG algorithm development, founded Mortara Instrument in 1982. Mortara Instrument's headquarters are located in Milwaukee, Wis., with European operations based in Bologna, Italy. Mortara Instrument is distinguished in the field of non-invasive cardiology for the innovations that are the core of the company's complete line of ECG products. These product innovations include the integration of 12-lead ECG technology in bedside monitoring, wireless stress testing, Holter and telemetry monitoring systems. The company's website is www.mortara.com