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Mortara Instrument Announces Availability of 12XML™ Module to Facilitate Compliance with Proposed FDA Standard

Mortara Instrument provides a complete digital solution for ECG data collection, transmission and export according to the proposed FDA standard.

MILWAUKEE, WI, USA

11 December 2001

Today Mortara Instrument, Inc. announced availability of its 12XML™ module to facilitate compliance with the proposed FDA standard for digital ECG data collection during clinical trials. The 12XML™ module, in combination with Mortara's E-Scribe/NT ECG Data Management System provides a complete digital solution for ECG data collection, transmission and export according to the proposed FDA standard.

Mark Mentzer, Director of Marketing for Mortara Instrument commented, "With the 12XML™ module, the E-Scribe/NT system provides for export of 12-lead ECG data according to the XML format proposed by the Food and Drug Administration. The combined 12XML™ and E-Scribe/NT solution will enable those companies involved in ECG collection for clinical trials to easily collect and export digital ECG data in the required format. The open architecture system also allows for easy integration with other information management systems as part of the data collection process."

Mortara Instrument is well-known for innovative ECG data management solutions. For over 15 years, Mortara has provided clinical information systems for hospitals throughout the world and customized solutions for unique workflow requirements. Mentzer further noted, "The issues surrounding ECG data collection for clinical trials are significantly different than those raised by traditional hospital ECG acquisition . The 12XML™ module was created to address this difference. Mortara has historically delivered similar customized solutions for ECG management. For example, the Federal Aviation Administration, which collects ECG records acquired by aviation medical examiners throughout the world, utilizes a customized extension of the Mortara E-Scribe/NT system for digital ECG data collection and review. As part of this solution, the E-Scribe/NT system and the collected ECG data are integrated within the workflow process for complete data capture and review within the FAA information system."

The Mortara E-Scribe/NT system also supports unique features such as Custom ID. Custom ID allows for user defined demographic fields to be managed and downloaded into the acquisition devices. Demographic field labels can be defined to match the terminology utilized by any particular trial. This reduces demographic data entry error and the operating costs associated with querying investigative sites after receiving incomplete or inaccurate data entry on ECG records.

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.