FDA Approves KardiaBand for Apple Watch

FDA Approves KardiaBand for Apple Watch”

And when you press record ECG, we flip into the FDA-regulated mode and then we record your ECG. However, the FDA just announced the approval of the first medical Apple Watch accessory, AliveCor's KardiaBand, which uses the wearable's heart rate technology and an attached sensor to provide EKG readings on the fly. The Apple Heart Study seeks to enhance the medical assisting reach of the Watch, by alerting and helping people much faster and better. "You can do what your doctor would do as soon as you got to the hospital, which is fire an ECG". The Apple Watch's display shows the reading's data using a line graph that's similar to how the Apple Watch shows other heart rate data, and informs the user if their heart rate is normal or abnormal. The regulatory nod covers AliveCor's KardiaBand, a device that clips onto Apple's smartwatch and performs EKG readings.

KardiaBand, the first FDA-cleared personal EKG band. The app may notify you on occasion to collect a full EKG readout if it detects an unexpected change in your heart rate as well. This means that the information provided by the device was inadequate for a doctor to get to the root of the problem. Results from the Kardia app are displayed on the face of Apple Watch and can be transmitted as a PDF to a physician.

Although AliveCor offers a standalone device called the Kardia Mobile, you must consider connecting the KardiaBand to Apple Watch to make EKG readings entirely on its own. It affects more than 30 million people worldwide, and one in four people over the age of 40 are at risk for developing it.

The Kardiaband system is available on all Series 3 Apple Watches for $199, though users must also subscribe to AliveCor's Premium service for $99 a year.

"If your heart rate goes outside the predicted values of our deep neural network, we fire an alert that says "This would be a good time to take an ECG".

KardiaBand, developed by AliveCor, stores readings in its app - which can be pushed out to a doctor for monitoring.

The reading could help detect risky electrical abnormalities such as atrial fibrillation. But the band is the first made by the Mountain View, CA-based company for the Apple Watch. However, Tim Cook has stated in the past that Apple doesn't want the Watch itself to be subject to FDA approval as that could slow down the pace of development. Powered by an internal lithium battery with a lifetime of 1-2 years, the sensor in KardiaBand is always ready to use - with the recording screen open on your Apple Watch, simply touch your index finger to the KardiaBand sensor to start a recording.

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