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Wednesday, September 29, 2010 4:20:42 PM
In particular, this relates to NewCardio's lead product, QTinno(tm), a software suite that provides automated, comprehensive cardiac safety analysis as defined in the ICH E14 Guidance for Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs.
Also, note the need for some way to detect ischemia risk during development. What this means is that a a drug with adverse risk of Myocardial Infarction (MI) does not get marketed. There is the potential for NewCardio's second product, Cardio3KG, to address this issue. NewCardio is developing the Cardio3KG solution for urgent diagnosis of serious cardiac conditions, including acute myocardial infarction and other acute coronary syndromes. In clinical studies to date, the Cardio3KG has shown substantially improved diagnostic accuracy relative to the standard 12-lead ECG.
The story is below and can be read at:
http://www.bloomberg.com/news/2010-09-28/recalled-drugs-tied-to-heart-risk-spurs-call-for-fda-review.html
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