September 13, 2005
Today Mortara Instrument, Inc. announced its release of the E-Scribe ECG Warehouse that was developed in collaboration with the Food and Drug Administration (FDA) (see original announcment at http://www.mortara.com/htmdocs/news/index.php?id=19
). This warehouse solution will act as a repository for annotated electrocardiographic (ECG) studies provided to the FDA in support of new drug applications. FDA reviewers will use the system to process ECG data with advanced tools and viewing technologies based upon Mortara's E-Scribe Rx product and VERITASÔ ECG algorithms. A public meeting to discuss receipt of data into and review of data from the E-Scribe ECG Warehouse will be held September 30th, in Rockville, Maryland.
As part of its release, Mortara will begin offering use of the E-Scribe ECG Warehouse to sponsors interested in utilizing it prior to submitting a new drug application for regulatory review. In addition to data warehousing, sponsors can elect to use the E-Scribe ECG Warehouse tools for dataset import and format validation; web-based query; and review of ECG data and VERITASÔ algorithmic scoring for rank ordering ECG records of interest.
Randy Spaulding, Vice President, Clinical Research commented, "We at Mortara are very excited to reach this important milestone in the E-Scribe ECG Warehouse development. We believe the warehouse will provide significant benefits to both FDA personnel throughout the review process and to sponsors who wish to enhance their cardiac safety assessment of new drugs." Spaulding further elaborated, "Based upon early adopter experience working with select sponsors, we have observed first hand that the E-Scribe ECG Warehouse tools will quantify a number of issues in ECG studies that will in turn lead to improvement of ECG study quality."
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