Landmark Study Leads FDA to Approve Two New Apple Heart Health Patents

Apple continues to shake things up in the tech world, but this time it is not because of the iPhone.  Not very long ago, the tech giant announced that the US Food and Drug Administration approves both its new heart rate sensing systems.  Apple, of course, seems to believe this will be the foundation for the next generation of wearable tech.

It was only September when the FDA approved two of Apple’s heart sensing technologies.  This is the hardware on the Apple Watch Series 4 and the software that is able to detect heart rate (which actually works on Apple Watch Series 1 and all others). Then, this week we learned how the Apple tested the software in the Apple Heart Study, which involved 419,093 Apple Watch users and then published the results in The American Heart Journal.

Mainline Health Lankenau Heart Institute cardiologist, Dr. Peter Kowey, steered the study committee. He comments that this study is a major step forward, not just because it can help to identify a common arrhythmia, but because it could be just the beginning of new ways to monitor heart patients.

The Stanford-based study has been led by lead investigators associate professor of cardiovascular medicine Mintu Turakhia, MD, assistant professor of cardiovascular medicine Marco Perez, MD, and professor of cardiovascular medicine Kenneth Mahaffey, who is also the study chair.

You may not be aware that while we are all mostly aware of wearable technology, as consumers, the industry is still a young one. And in the short time that these have been around, we have not had many devices which the FDA has approved to be as an actual medical device.  One such approved device was the Alivecor wrist strap, which launched just last year.

What is important about this particular achievement, though, is that the FDA approval of Apple’s two patents marks the first time that a major brand succeeded in the approval process by way of clinical trial.

Here’s another interesting thing:  the study is not even complete yet!  Actually, the study has just entered into its final phase of data collection and is slated for completion within perhaps the next three or four months.

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