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Mortara Instrument Announces ECG Warehouse Contract Awards With US FDA
Date:9/30/2010

MILWAUKEE, Sept. 30 /PRNewswire/ -- Today Mortara Instrument announced the award of two contracts from the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER).  The first award is a multi-year contract for continued maintenance of the FDA ECG Warehouse, and the second award supports the expansion of the ECG Warehouse to incorporate continuous 12-lead ECG recordings.

Mortara has a long-standing relationship with the FDA, providing ECG algorithm tools and data warehousing solutions to support the Agency's regulatory review of cardiac safety data.  Since 2006, the FDA has been using the ECG Warehouse and toolset to review ECG studies submitted to them.  To facilitate the FDA review process, the ECG Warehouse incorporates Mortara's VERITAS™ ECG algorithms which analyze and quantitatively evaluate the submitted ECG data.  Today the ECG Warehouse contains over 4 million ECGs from more than 420 ECG studies, all of which have been automatically analyzed by the VERITAS algorithms.  

Under the ECG Warehouse maintenance contract, Mortara will continue to support Sponsor and ECG Central Laboratory upload of ECG studies, provide support to FDA personnel, and provide on-going basic development enhancements to the ECG Warehouse.

The ECG data submitted from cardiac safety studies are often extracted from continuous ECG recordings done with 12-lead Holter monitors or 12-lead telemetry at protocol-specified time points.  Under the contract to supply an ECG Warehouse for continuous 12-Lead Holter recordings, Mortara will be tasked with providing the Agency the means to review the full underlying ECG data set as well as the extracted ECGs.  The expanded warehouse tools will include provision for web-based upload, navigation of continuous data, arrhythmia identification, and waveform morphology comparison.

The intent is to support review of continuous recordings that are typically
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