FDA greenlights Transoma for ECG data review

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Transoma Medical, a manufacturer of implantable cardiac monitoring (ICM) systems, has received FDA 510(k) marketing clearance for its new data review feature on its  implantable wireless ECG monitor, Sleuth AT.

The St. Paul, Minn.-based company said its data review feature allows a clinician to access up to 99 events stored on the patient's personal diagnostic manager (PDM), which is a handheld device that retrieves and stores ECG data from the implanted device prior to automatic transmission to the 24/7 monitoring center. Each stored ECG strip is labeled with the time and date of the cardiac event, allowing clinicians to correlate symptoms with rhythms.

As a remote and automated system, Sleuth AT not only captures ECG strips containing arrhythmias, it also allows the patient to capture data by pressing a button on the handheld PDM after experiencing a symptom.

Transoma said that data captured by the implanted device is automatically transferred to the PDM, providing an additional 10.5 hours of ECG storage. Data stored on the PDM is automatically transmitted to a 24/7 monitoring center where cardiac technicians review the data and alert clinicians to clinically-significant events.