Mortara to provide ongoing support for FDA ECG Warehouse including continuous ECG studies analyzed by VERITAS™.
MILWAUKEE – Mortara Instrument, Inc. (Mortara), a Milwaukee-based designer, developer and manufacturer of diagnostic cardiology and patient monitoring technologies, announced today it has been awarded a multi-year contract for ongoing maintenance and support of the FDA ECG Warehouse.
Mortara collaborated with the FDA to develop the ECG Warehouse which was initially deployed in 2005. The ECG Warehouse acts as a repository for annotated electrocardiograph (“ECG”) studies provided to the FDA in support of new drug applications. With the ECG Warehouse, the FDA uses Mortara’s VERITAS ECG algorithms and viewing technologies to review ECG data submitted as part of new drug applications.
Since inception of the ECG Warehouse, more than 9 million resting ECGs have been analyzed with Mortara’s VERITAS algorithms, making this one of the largest cloud-based clinical data repositories in the world. The ECG Warehouse has subsequently been expanded to also include continuous 12-lead recordings, which now number nearly 800 in total. The warehouse tools include web-based upload, navigation of continuous data, arrhythmia identification and waveform morphology comparison.
Under this expanded ECG Warehouse 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 including advances in the VERITAS ECG algorithms.
“Mortara is pleased to continue its longstanding relationship with the FDA in providing the ECG Warehouse solution,” said Dr. Justin Mortara, CEO of Mortara. “This award is testimony to our leadership role in ECG acquisition and algorithm technologies. We are honored to be chosen by the FDA and to play our part in the cardiac safety evaluation of new drugs.”
Exhibitor Data Sheet