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FDA Approves Israeli-Developed Tool That Diagnoses Heart Disease

Good news for patients with acute chest pains: The Israeli company BSP, which develops and produces advanced tools for non-invasive diagnosis of heart disease, recently won approval by the Food and Drug Administration (FDA) to market and sell its HyperQ Rest System. The HyperQ Rest System aids in the diagnosis of patients with chest pain in the emergency room and helps to identify acute coronary events using unique analysis of high frequency ECG signals, recorded during rest. BSP has proven in clinical trials that its products achieve significant improvement in the diagnosis and monitoring of cardiovascular disease in relation to standard stress and resting ECG tests.

The American Heart Association also recently stated that high-frequency ECG technology, which is used by the company, is an effective method for detection of coronary heart disease during a stress test. The FDA has approved the marketing and sale of the system based on clinical trials conducted in emergency departments for the diagnosis of Acute Coronary Syndrome (ACS) in patients with acute chest pain. At present BSP holds marketing and sales approval in the United States and Europe (FDA and CE) for its stress and resting ECG systems. (via Israel21c)

[Photo: Army Medicine / Flickr]