Transoma's Sleuth ECG monitor:
This article was originally published in Clinica
Executive Summary
Transoma Medical has gained US 510(k) clearance for its Sleuth electrocardiogram monitoring system. The St Paul, Minnesota firm claims it is the first wireless, implantable heart monitor for humans. The Sleuth provides data to aid the diagnosis of cardiac arrhythmias and other conditions that can cause unexplained fainting. Patients who feel faint can press a symptom button to activate the device for the duration of the fainting spell. The system also automatically captures ECG data when the patient's heart rate is above or below programmed limits. In the US, sudden fainting accounts for 6% of hospital admissions, and is caused by a cardiovascular condition in 90% of these patients.