This is significant considering that ILRs have been viewed as the industry gold standard, allowing for long-term surveillance of AFib.
More leads mean increased accuracy, which could potentially mean more lives saved.
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.