September 1, 2014

AliveCor’s iPhone ECG wins FDA Clearance

By: On December 4, 2012

AliveCor has received 510(K) FDA clearance for its iPhone-based heart monitor. According to MobiHealthNews, the device will be available for pre-order by physicians via the company’s website immediately for $199. Early next year, doctors will be able to write a prescription for heart patients to obtain the device. It is expected that the cost to patients for a prescribed device will be close to $100. AliveCor hopes to get clearance to sell the device over-the-counter later in 2013.

The device, which debuted to great fanfare at the consumer electronics show two years ago, is a clinical quality ECG monitor in the form of a snap-on case that works with an iPhone 4 or 4S. The company expects to launch a “universal module” version of the device that would work with other iOS devices as well as Android devices.