Under this extension of this cooperative R&D agreement (CRADA), Mortara will continue to provide on-going development enhancements to the electrocardiogram (ECG) Warehouse, which is used to store and review ECG submissions associated with new drug applications.
Enhancements planned for the ECG Warehouse include support for longer ECG records, as well as the incorporation of additional Veritas scoring criteria. These developments reflect the trend in ECG data collection to move beyond discrete ECG acquisition and analysis and toward continuous ECG acquisition and analysis, the company said.
Justin Mortara, CEO of Mortara Instrument, said: “We are pleased to move forward in our collaboration with the FDA. With the experience of applying our Veritas algorithms over millions of ECGs in the ECG Warehouse and thousands of continuous 12-lead recordings outside of the ECG Warehouse, we see opportunities to further enhance the tools utilized by FDA reviewers as well as to expand the horizon of our automatic algorithm offerings.”