The FDA has cleared the eMotion ECG Mobile, a Finnish continuous ECG monitor that connects to Android smartphones, as a Class 2 medical device. The ECG Mobile, made by Mega Electronics, already has a CE Mark and has been available for purchase in Europe since late 2012, but the company's securing of FDA clearance suggests it may be bringing the device to the United States to compete with mobile ECG platforms like the well-established AliveCor or as-yet-unlaunched Cardiac Designs.
According to a sales brochure from Mega, the device, a 3-lead wireless ECG, is designed to be prescribed by a doctor and worn continuously under a patient's clothing. It continuously sends ECG readings to the user's Android smartphone via Bluetooth and, from there, sends the data over the mobile network to a server. The patient's clinician can then access readings via a web browser.
The device will also send the clinician an alarm when it detects irregular heart rate readings. The physician can analyze the data and send an email to the patient. If the patient is using additional Bluetooth connected devices like a weight scale or blood pressure monitor, the monitor application can display that data as well.
Users can elect to enable a GPS feature in the connected app, so that first responders can find them easily in an emergency. The company recommends the device for use in research, ambulance care, pre- and post-surgical heart patients, and people expecting heart problems.
MobiHealthNews has been reporting on FDA-cleared continuous mobile ECGs for a number of years, including Norwegian company Curvus and Corventis' Nuvant system in 2010. eMotion ECG Mobile stands out because it uses a smartphone rather than a separate, dedicated transmitter. Other devices, like AliveCor and Cardiac Designs' ECG Check, use the smartphone, but only for sporadic, rather than continuous monitoring.