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Mortara Instrument to Participate in Special Workshop on the Impact of Regulatory Requirements on the Collection, Analysis, and Submission of ECG Data MILWAUKEE, Wis. USA, 10 April 2003 Mortara Instrument will participate in an informational session at the upcoming Institute for International Research Conference being held in Philadelphia on June 23rd and 24th in Philadelphia, entitled “The Impact of Regulatory Requirements on the Collection, Analysis, and Submission of ECG Data” Barry Brown, Product Integration Manager at Mortara Instrument, will present material relating to new and emerging regulatory requirements regarding the submission of digital ECG data, the new HL7 Annotated ECG submission standard, ECG data collection methods (including continuous 12-lead Holter and traditional 12-lead resting ECG acquisition), management of digital ECGs in clinical trials and modern approaches to the analysis of repolarization abnormalities (including QT measurement methods and other promising techniques). Brown commented, “This is a very exciting time to be involved in the collection of ECG data for clinical trials. There are a number of emerging solutions in the areas of acquisition, measurement, annotation and export of digital ECG data that should greatly improve the quality and timeliness of data. Hopefully this will be just the beginning in a series of events that will benefit everyone involved, most importantly the people who need the compounds being tested.” As the principal architect of the format for submission of ECG data collected in clinical trials to the FDA, Brown and Mortara Instrument hope to serve in an informational capacity to keep the entire community of interested parties as up to date as possible on events related to the format. To facilitate awareness, Mortara Instrument has dedicated a section of its website to information regarding the history and progress of the FDA initiative at: www.mortara.com/Research_Proposed ECG Interchange Standards 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 |
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