First Workshop Announcement: Regulatory Review of Continuous ECGs

October 01, 2013

Washington D.C. - December 11, 2013

Milwaukee, Wisconsin – October 1, 2013 – Mortara Instrument initiated the expansion and upgrade of tools for submitting continuous ECG data to the ECG Warehouse in 2010. As part of this initiative, the FDA held a public meeting on March 12, 2012 to discuss changes in how continuous digital ECG data is gathered and submitted to the ECG Warehouse, as well as new tools for visualizing the continuous, annotated ECG recordings. An extension of the Health Level-7 Annotated ECG standard data format was proposed for this purpose. The new data format is intended to facilitate electronic submission and sharing of ECG data from continuous recordings.

Now that the ECG Warehouse stands ready to receive data in the proposed format, sponsors and ECG core laboratories are moving forward quickly to implement compliant solutions.  As expected, through these implementation activities, several questions regarding the proper utilization of the continuous ECG Waveform Standard have surfaced.

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 Regulatory Review of Continuous ECGs.

This one day workshop, to be held in Washington, D.C. on December 11, 2013, will feature presentations on the following topics:

  • Why the FDA wants to review continuous ECG data
  • What is continuous ECG data, and how is it collected, analyzed, and managed
  • Clarify missions of various organizations, the data they collect, and the tools they use
  • A review of the HL7 aECG v1 Standard  
  • Present changes in v2 to support continuous ECGs
  • ECG Warehouse v2: the new tools
  • Beyond ICH using aECG v2: examples from the CSRC white paper
  • Case Studies from industry leaders

The presenters will include:

Dr. Norman Stockbridge, Director of the Division of Cardiovascular and Renal Products in FDA's Center for Drug Evaluation and Research
Dr. Fabio Badilini, F.A.C.C. Chief Scientist of AMPS
Barry Brown, Product Integration Manager of Mortara Instrument

Attendance will be strictly limited to encourage open exchange and discussion between presenters and participants. Early bird registration fee (until Oct 31st) is $2,000 per attendee, $2,500 afterward. Additional attendees from the same companies will enjoy a reduced fee of $500 per person.  To reserve space and receive an invitation along with the complete workshop agenda, please contact: Aimee.Kops@Mortara.com.   

We look forward to a productive workshop in December.

About Mortara Instrument

Mortara Instrument, Inc. was founded 30 years ago and today is a recognized technology leader in the world of ECG. Mortara’s global headquarters is located in Milwaukee, Wisconsin with operations in Australia, Germany, Italy, the Netherlands, and the United Kingdom. Mortara is distinguished in the field of non-invasive cardiology for 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 manufactures and distributes its ECG devices and related technologies worldwide. Mortara’s market leadership is a result of its substantial investment in R & D which has fueled the introduction of many new Mortara products uniquely positioned to benefit customers in their everyday use of diagnostic ECG devices. To learn more about Mortara Instrument and its expanding product portfolio visit www.mortara.com.

Mortara Instrument Media Contact:  Sondra Kaufman; sondra.kaufman @ mortara.com

 

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