KardiaMobile
The company hopes that its more descriptive reports will distinguish the personal ECG offering from others limited to atrial fibrillation detection alone.
The agency also warned consumers of unregulated diabetes products and outlined plans for AI device regulation.
The KardiaMobile 6L builds upon its predecessor with a third electrode placed on its back side, allowing cardiologists better insight into device owners' arrhythmias.
The company has received multiple clearances as it gears up for the release of its next-generation smartphone-connected ECG platform.
AliveCor’s KardiaMobile five times more effective at detecting heart arrhythmia than standard tests…
Researchers have now called for the device to be incorporated into standard care in A&E departments.