Transoma Medical Receives FDA Marketing Clearance – ECGs on Mobile Handheld Device from Implanted Device

Information is sent through frequent ECG samples to Manage Complex and often Changing Arrhythmias with patients to a cardio center for technicians to analyze. From here physicians are alerted for any significant events. One nice move is a physician’s portal, but we need to go the next level up and have the information brought to a Personal Health Record, so perhaps this is a new potential vendor for Microsoft.

St. Jude has a similar device and is now connected to the HealthVault. (related reading below)

Cardio implants are now being capable of sending SMS, faxes and emails themselves too. With this device, the patients too can see the information and thus the need to include in a PHR. The procedures is minimally invasive, since the device is not providing a function for the heart, but rather creating a ECG electronic report card. With the FDA marketing clearance, we could be seeing this device recommended by physicians soon. It does make you wonder exactly how much time will transpire before we all have some type of device someday. BD

Transoma Medical, Inc., manufacturer of Sleuth^® and Sleuth AT^™, the only wireless and automated implantable cardiac monitoring (ICM) systems has received FDA 510(k) marketing clearance for its new Data Review feature on Sleuth AT. The Data Review feature allows any clinician to easily access up to 99 events stored on the patient’s Personal Diagnostic Manager (PDM). The PDM 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 making it easier for clinicians to correlate symptoms with rhythms.

Not only does Sleuth AT capture ECG strips containing arrhythmias automatically, it also allows the patient to capture data by pressing a button on the handheld PDM after experiencing a symptom. All 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 certified cardiac technicians review the data and alert clinicians to clinically-significant events, providing a high degree of specificity.

Now with Sleuth AT, the added benefit of ECG access on the handheld device means any available clinician can view recently captured events without a programmer, even if the patient has been away from home. I am hopeful this will further speed access to critical information.”

At the third-party Monitoring Center, certified cardiac technicians review the patient’s ECG data and provide information to the physician to aid in diagnosis and ongoing treatment. Physicians can access this information via a secure Web portal, and have the reports faxed or e-mailed to them as they prefer. If the cardiac technician observes a particularly concerning arrhythmia, the patient’s physician will be contacted immediately.