AliveCor, the digital health company led by ex-Googler Vic Gundotra, says the Food and Drug Administration has approved its EKG band accessory for the Apple Watch. Gundotra says the Kardia Band, as the product is called, is the first Apple Watch health accessory to get FDA clearance.
Kardia Band attaches to the Apple Watch like any other replaceable watch band. The user rests a finger on the sensor pad embedded in the band, allowing an EKG reading to be taken. (Electrocardiograms detect irregularities in the electrical impulses that trigger the contractions in the four chambers of the heart.) The Kardia Band transmits its EKG reading to the Apple Watch (via a high-pitch audio signal) where it’s displayed in real time as a moving waveform. When the 30-second EKG is finished, the user can view it on their phone or easily send the results as a PDF to their physician.
Doctors can diagnose hundreds of diseases using EKG data, but AliveCor is cleared by the FDA only to record the EKG and to advise a user that the reading is normal, or possibly indicative of atrial fibrillation. Atrial fibrillation is is the most common heart arrhythmia, and a leading cause of stroke. It affects more than 30 million people worldwide, and one in four people over the age of 40 are at risk for developing it.
Gundotra says the Kardia Band will be useful to younger people who have diagnosed heart conditions, and by people in their 40s or older who have congenital heart disease in their families.
A first version of the Kardia Band was released in Europe last year,…