New ECG device receives FDA clearance

By Sharon Niv, Ph.D.

The FDA recently granted clearance to a device that measures electrocardiography (ECG) data from ones fingertips. ECG measures electrical activity associated with heart beats, and is used to monitor pulse, as well as the muscular health of the heart. Abnormalities from ECG readings can be indicative of hearth disease or distress, and are used diagnostically by physicians. This Singapore-made device, the EPI Mini, has been on the market in Asia for a number of years, but only recently received US clearance as a medical device, joining other home ECG devices such as AliceCor, an iPhone cover with built-in ECG sensors.

Unlike the Alivecor or ECG Check, the EPI Mini is not a cover for a smartphone, but a separate device that that transmits information via bluetooth to a smartphone application. This information can be tracked both by individuals and their doctors. In the specific case of EPI Mini, a 24 hour concierge is available to automatically interpret the ECG results and respond via text. Although the FDA has made this device available by prescription only, and is not approved for diagnostic purposes, requiring that a doctor still be involved in the patient’s care. However, this development is a further step toward increasing the ways in which hearth health can be monitored at home.

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