FDA clears Smartheart mobile ECG device

By: Brian Dolan | Apr 17, 2012        

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Smartheart Mobile ECG SHL TelemedicineAs we reported in our Mobile Health: State of the Industry Q1 2012 report, the FDA cleared SHL Telemedicine’s Smartheart device, which is meant to be used by consumers to send their own 12 lead ECG data to a physician from the device. Smartheart transmits the ECG data to the user’s mobile phone via Bluetooth.

According to the company, “the Smartheart is a personal, hand-held battery powered, 12 lead ECG and rhythm strip device with Bluetooth connection. The Smartheart acquires ECG data via attached electrodes. The Smartheart transmits the data in real-time to a suitable Bluetooth communication device for forwarding it to a remote location and a certified medical professional capable of interpreting the results.”

Here’s how the FDA 510(k) summary describes the intended use cases for SHL’s device:

“The Smartheart device is intended to condition an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology and cellphone or communication device to a remote location. The Smartheart device is designed to be used by a patient to transmit a 12 lead ECG and rhythm strip in real-time to enable review at a physician’s office, hospital or other medical receiving center.”

SHL’s Smartheart device gained attention in the press after a demonstration at TechCrunch’s Disrupt event last year. At the time the company expected to sell the device for about $500 and an accompanying data analysis service that includes reports and medical advice would carry an additional subscription fee that the company said would cost “way” less than $20 each month.

While SHL’s device does include a 12 lead ECG, it is much more expensive than the more widely known (single lead) AliveCor iPhoneECG, which is not yet FDA cleared. The AliveCor device is expected to retail for about $100. As we reported in February, AliveCor expects to secure its CE Mark soon.

More on Smartheart’s FDA 510(k) clearance over at the FDA here. (PDF)
Catch up on more highlights from Q1 2012 by buying our Mobile Health: State of the Industry report here.