April 25, 2019
The last couple of months saw a pair of regulatory clearances from mobile ECG maker AliveCor surface on the FDA’s 510(k) premarket notification database — the first in March for something called KardiaAI, and the latter a dual-update for the company’s existing KardiaMobile and KardiaStation platforms for consumer and point-of-care use.
With AliveCor keeping mum at the time, MobiHealthNews...
September 6, 2017
AliveCor, makers of the Kardia Mobile smartphone-connected ECG, announced the results of several major studies of the technology, including one that was published online today in Circulation, the journal of the American Heart Association. The studies show the effectiveness of the technology in discovering atrial fibrillation that might otherwise have gone undetected, as well as its ease of use.
November 28, 2016
Since July 2016, Apple has been in discussions with the FDA about two FDA-regulated products in the cardiac monitoring space, MobiHealthNews has learned. The revelation comes from a collection of emails MobiHealthNews obtained via a Freedom of Information Act request to the FDA.
On July 14, 2016, Robin Goldstein, at the time Principal Counsel for Apple, sent an email to FDA Associate Center...
October 28, 2016
Mountain View, California-based AliveCor, which makes an FDA-cleared mobile electrocardiogram (ECG) device and companion app collectively called Kardia Mobile, has released new features that make it easier to integrate weight, activity, and blood pressure readings via Apple Health or Google Fit.
The added features built on Kardia Mobile’s existing monitoring capabilities for atrial fibrillation,...