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Workshop Announcement - Establishing an FDA Compliant Digital ECG Process
June 15, 2005
Bergamo, Italy

As of January 20th, 2004 the Annotated ECG (aECG) XML Waveform Standard was finalized and formally adopted by the Health Level 7 (HL7) standards organization. HL7's adoption of the aECG XML Waveform Standard was the culmination of an effort initiated in November of 2001 by the US Food and Drug Administration (FDA) to enable submission of digital aECGs to establish the cardiac safety of new drugs. The final aECG Waveform Standard was authored through an ad hoc group consisting of representatives from sponsor organizations, ECG core laboratories, academic institutions and medical device companies.

With the standard finalized, sponsors and ECG core laboratories are moving quickly forward to implement compliant solutions.As expected, through these implementation activities, several questions regarding the proper utilization of the aECG Waveform Standard have surfaced including:
  • What needs to be included in the annotated ECG XML files?
  • What file structure needs to be used for individual aECGs?
  • What duration requirements are there for the aECGs?
  • What vocabulary can be used for the annotations?
  • How to ensure proper adherence to the standard?
  • When will the FDA begin using the ECG Warehouse and how will they use it?
In order to provide answers to such implementation questions and other related issues, AMPS, LLC and Mortara Instrument, Inc. are organizing a workshop designed for representatives from sponsor organizations and ECG core laboratories who are responsible for compliance with the new aECG XML standard.

This one day workshop will feature presentations from two primary authors of the aECG XML standard, Fabio Badilini of AMPS and Barry Brown of Mortara Instrument. Included in the workshop materials will be a thorough implementation guide for the aECG XML standard and one AMPS XMLFDA Viewer Light software license. Attendance will be strictly limited to encourage open exchange and discussion between presenters and participants.

Here is the complete Workshop Agenda (.pdf format).

About Mortara
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 innovations that are the core of the company's complete line of ECG products including electrocardiographs, stress exercise systems, Holter systems, data warehousing solutions, and cardiology monitoring systems. The company's website is www.mortara.com.

Randy Spaulding - VP, Clinical Research
randy.spaulding@mortara.com
1-414-354-1600

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