Transoma nets FDA clearance for upgraded cardiac monitor

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Transoma Medical, a manufacturer of automated implantable cardiac monitoring systems,  received FDA marketing clearance on a second-generation product, Sleuth Advanced Trending (AT) cardiac monitoring system.

The Sleuth products offer physicians the capability to diagnose patients with recurrent, unexplained fainting and abnormal heart rhythms, according to the St. Paul, Minn.-based company.

With Sleuth AT, Transoma said that physicians can now choose to program the capture of high-quality electrocardiogram (ECG) strips at frequent intervals, providing insight into complex arrhythmias which are often asymptomatic and frequently changing. The captured ECG strips are automatically transferred to a 24/7 monitoring center, staffed by Certified Cardiac Technicians, who classify and notify physicians of the presence of a variety of cardiac arrhythmias, such as ventricular tachycardia, bradycardia, supraventricular tachycardia and atrial fibrillation.