This means that the agency will consider AliveCor's technology on an accelerated clearance track.
The company has also introduced the SmartRhythm feature that continuously monitors heart rate from the Apple Watch.
The two parties have teamed-up to develop tools for medical and non-medical personnel to easily screen for congenital long QT syndrome (LQTS) early.
The platform is designed to help doctors monitor patients for the early detection of atrial fibrillation, which is the most common cardiac arrhythmia.
Both iOS and Android versions combine ECG, body weight and blood pressure to improve overall heart health and lower the risk of cardiovascular disease.
The study involved patients already wearing the standard Holter ambulatory event monitor with AliveCor's device being added to the mix.
The 300-patient randomized trial will test the effect of remote monitoring on atrial fibrillation (AF) using AliveCor's Kardia Mobile device.
Pending FDA's 510k clearance, the device provides caregivers the opportunity to take a more active role in helping their loved ones engage in their own care.
The patch can watch every heartbeat for adverse cardiac events and transmit findings, in near real-time, to a clinical service center for immediate follow-up.
The new CEO, Vic Gundotra, served as Senior Vice President at Google from 2011 until April 2014, heading up the company's social initiatives.