Navigation Links
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 the underlying data source for the discrete ECGs that are currently being submitted to the FDA ECG Warehouse today.  This work will be the first step in positioning the FDA to request the upload of continuous recordings as part of the cardiac safety regulatory review process.

Mark Mentzer, Vice President of Clinical Research for Mortara Instrument commented, "Mortara is pleased to utilize its expertise in the field of continuous 12-lead ECG acquisition and analysis to provide the Agency with an expanded version of the ECG Warehouse.  Mortara is the leading provider of 12-lead continuous data technology, and has proven experience in providing tools for the regulatory review of ECG data.  This award is validation that we are making a difference in cardiac safety evaluation and that our expertise will help to shape the future."

About Mortara Instrument, Inc.

Mortara Instrument, Inc., based in Milwaukee, WI, is distinguished in the field of non-invasive diagnostic cardiology for innovations that are the core of the company's complete line of ECG products including electrocardiographs, stress exercise systems, Holter systems and data warehousing solutions, and cardiology monitoring systems.  Mortara Instrument manufactures and distributes its ECG devices and related technology worldwide.  The company's web site is www.mortara.com.


'/>"/>
SOURCE Mortara Instrument
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. PAREXEL Enhances Early Phase Cardiac Safety Capabilities Through Alliance With Mortara Instrument
2. Instrumentation Laboratory to Host 2nd Asia Pacific Hemostasis Forum
3. ForteBio Announces Launch of Protein G Biosensor for Use on Companys Octet® Instruments
4. Specialty Surgical Instrumentation Launches New Interactive Web Site
5. Panasonic Digital Hearing Instruments Now Available in the U.S. Hearing Care Market
6. Reportlinker Adds Clinical Laboratory Testing Volume 1: Reagents and Instruments
7. MicroAire Surgical Instruments Acquires Endotine® (Formerly Owned by Coapt Systems)
8. Instrumentation Laboratory Introduces Fully Automated, Liquid, Ready-to-Use HemosIL® HIT-Ab(PF4-H) Assay in Europe
9. Instrumentation Laboratory Receives FDA Clearance for New Automated Total Bilirubin Assay on GEM Premier 4000 Critical Care Analyzer
10. Steerable Technologix LLC Announces Release of SurgiSteer Laparoscopic Instruments
11. PolyTouch Medical Ltd. Receives FDA Clearance to Commercialize PatchAssist(TM) - an Innovative Surgical Instrument Intended to Facilitate the Delivery of Soft Tissue Prosthetics During the Laparoscopic Repair of Soft Tissue Defects
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... -- Research and Markets has announced the addition ... report to their offering. ... The World Market for Companion Diagnostics covers the world ... in the report includes the following: , ... by Region (N. America, EU, ROW), 2015-2020 , World ...
(Date:6/23/2016)... June 23, 2016  MedSource announced today that ... e-clinical software solution of choice.  This latest decision ... value to their clients by offering a state-of-the-art ... relationship establishes nowEDC as the EDC platform of ... full-service clients.  "nowEDC has long been a preferred ...
(Date:6/23/2016)... June 23, 2016 Roche (SIX: RO, ROG; ... for its Elecsys BRAHMS PCT (procalcitonin) assay as a ... septic shock. With this clearance, Roche is the first ... integrated solution for sepsis risk assessment and management. ... infection and PCT levels in blood can aid clinicians ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users ... - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 ... Pro X . Simply select a ProHand generator and drag it above media or ...
(Date:6/25/2016)... Montreal, Canada (PRWEB) , ... June 25, 2016 , ... ... the pursuit of success. In terms of the latter, setting the bar too high ... low, risk more than just slow progress toward their goal. , Research from ...
(Date:6/24/2016)... Texas (PRWEB) , ... June 24, 2016 , ... ... International Conference and Scientific Sessions in Dallas that it will receive two significant ... of the grants came as PHA marked its 25th anniversary by recognizing patients, ...
(Date:6/24/2016)... Plano, TX (PRWEB) , ... June 24, 2016 , ... ... taking part in Genome magazine’s Code Talker Award, an essay contest in which patients ... for an award to be presented at the 2016 National Society of Genetic Counselors ...
(Date:6/24/2016)... ... June 24, 2016 , ... National recruitment firm ... sciences executive with extensive sequencing and genomics experience, as Vice President of North American ... Hill will be responsible for leading the sales team in the commercialization of the ...
Breaking Medicine News(10 mins):