AliveCor’s Personal ECG Device Gets FDA Clearance

AliveCor has received 510(k) clearance from the FDA for its KardiaMobile 6L, an electrocardiogram (ECG) device intended to calculate patients' QTc intervals — a heart measurement than can be used to assess the risk of cardiac failure.

The Mountain View, Calif.-based company says the device can help healthcare professionals who may not have ECG equipment readily available and need to prescribe drugs that are known to cause QT prolongation, a condition that can greatly increase the risk of sudden death.

The handheld device enables healthcare professionals to measure patients' QT intervals in 30 seconds and it does not require a hospital setting.