Medical Imaging News

February 28, 2007

GE Healthcare to Support the FDA HL-7 XML Annotated ECG Standard

Aiming to help research sponsors bypass an expensive certification process, a new program from GE Healthcare allows drug application sponsors and contract research organizations to transform data acquired on GE Healthcare ECG recording and analysis equipment to FDA XML format.

The FDA is collecting ECG data in FDA HL-7 XML from clinical trials to assess cardiac safety, particularly the risk of a potentially fatal arrhythmia called Torsades-de-Pointe.

Once formatted, the data can be submitted directly to the FDA for review, thus eliminating the need to comply with the expensive process of certification common of existing solutions.

GE Healthcare produces a variety of systems used by drug companies, ECG core labs, and research organizations for clinical trials and research, including the MUSE Cardiology Information System, MAC 1200, and MAC 5500.

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