[6] After the video received attention from the media, Albert was approached by venture capitalists and industry partners to fund the new company.
[10] To secure the FDA-clearance, AliveCor ran a clinical trial to test both the device hardware and the associated iPhone app.
[11] A second study looked at whether 54 participants with no medical training could determine how to use the phone case to record ECG's on themselves and others.
The 500 treatment-group patients recorded 60,440 EKGs at home throughout the study, and 76% of these were interpreted as "normal" (not AF) by the Kardia app's automated algorithm.
However, the false positive rate was 95%, meaning that the automated software often reported atrial fibrillation in cases where the cardiologist concluded there was no AF.
[18] In 2017, the company introduced software that used a neural network to build a profile of the user's ECG patterns over the course of about a month.
Then later, if something changes, the device can alert the patient's doctor of a potential abnormality even if couldn't make a specific diagnosis.
[5] By the end of 2017, the FDA had cleared the KardiaBand ECG reader as a medical device accessory to the Apple Watch.
The Biden administration was given 60 days to decide whether to veto the ruling, and a $2.00 per unit bond for was set for watches imported or sold during the review period.
However, the ITC suspended enforcement of both the import ban and bond assessment pending the outcome of appeals challenging the USPTO decision.
In June '24 US Customs and Border Protection found that the newly designed Apple Watch does not infringe any of the AliveCor patents in the original ITC case.