Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Mortara Instrument, a provider of continuous ECG acquisition and analysis tools, has extended its cooperative R&D agreement with the FDA Center for Drug Evaluation and Research.
Subscribe to our email newsletter
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.”