Research

FDA Clears Medical Grade EKG Analyzer For The Apple Watch

FDA Clears Medical Grade EKG Analyzer For The Apple Watch

"Through the Apple Heart Study, Stanford Medicine faculty will explore how technology like Apple Watch's heart rate sensor can help usher in a new era of proactive health care central to our Precision Health approach", Lloyd Minor, Dean of Stanford University School of Medicine, said in a statement.

The FDA has approved the first medical device accessory for the Apple Watch, made by AliveCor, whose CEO is former Google+ boss Vic Gundotra. The new SmartRhythm feature taps into AI and when combined with the Watch's heart rate data and activity sensors will evaluate the correlation between heart activity and physical activity.

For the Apple Heart Study, the accompanying app will analyze those heart rhythms for evidence of AFib, a leading cause of stroke that's responsible for some 130,000 deaths and 750,000 hospitalizations per year in the US. Both apps will monitor heart rate for signs of AFib and escalate to an ECG if necessary - but while the Apple study's ECG will come in the mail, AliveCor's is built right into the Watch strap.

Apple today launched the Apple Heart Study app, a first-of-its-kind research study using Apple Watch's heart rate sensor to collect data on irregular heart rhythms and notify users who may be experiencing atrial fibrillation (AFib).

In an earlier interview with mHealthIntelligence.com, Gundotra said an mHealth monitor that can track EKG holds promise for treating much more than AFib.

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Doctors and medical researchers around the world have been using iPhone and Apple Watch to revolutionize medical studies.

The feature uses machine learning models running on the watch itself, according to the company. To date, Apple's ResearchKit and CareKit platforms have been used by over 500 researchers and more than three million participants. Currently, Apple's wearable can alert you when your heart rate spikes, but SmartRhythm uses AliveCor's deep neural network and your history of heart rate data to determine a healthy and normal heart rate range for you in relation to your activity levels.

FDA clearance means that AliveCor can sell and market it as a medical device, but users don't need doctor approval to use it.

The Kardiaband costs $199, but requires a $99 AlivCor annual subscription to unlock full functionality. "If you look at medical products, a defibrillator, the pacemaker that my father have, they don't show anything to the consumer. The DNA of AliveCor is very different".


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