FDA Clears AliveCor’s KardiaBand - the Apple Watch’s First Medical Accessory
AliveCor’s KardiaBand, an Apple Watch accessory that takes medical-grade electrocardiogram readings, has this week been cleared by the FDA, making it the first smartwatch medical accessory to be granted FDA approval.
Why is this important? For smartwatches and other wearables to penetrate the health industry fully, they need to have the backing of local and national health administrators. In the US, the obvious one is the Food and Drug Administration (FDA). In 2016, the FDA published a clarification on their stance regarding medical devices and digital health, stating that “The FDA’s Center for Devices and Radiological Health is excited about the advancement of medical devices, and the convergence of medical devices with connectivity and consumer technology.”
An electrocardiogram (EKG) is a quick, safe and painless way to check heart rhythm, and helps medical professionals diagnose a wide range of conditions, such as the likelihood of a heart attack, thickening heart muscles and ischemia.
The KardiaBand takes accurate EKG readings in an interesting way. It is a watch band with a built-in medical-grade EKG sensor. All you do is place your thumb or finger on the sensor for 30 seconds, and the deed is done. To see the detailed electrocardiogram, you view the results on an iPhone or a set of minimised results on the Apple Watch.
To be granted FDA approval now means an awful lot to AliveCor, who created the world’s first cardiac health platform for the Apple Watch. Their products also include the KardiaMobile, which lets you know instantly if your heart rhythm is normal and lets you view EKG data in real-time on a smartphone. The KardiaBand is a more interesting proposition though, since it offers accurate (and now, FDA approved!) EKG readings on your wrist. It is available in both 42mm and 38mm sizes for all Apple Watch models.
Interested in a KardiaBand for your wrist? Despite being extensively trialled by medical professionals around the world, you can buy one for personal use. The UK price is £199.00 (38mm, 42mm), although AliveCor will be updating their site soon with USD pricing, since they can now sell it in the US thanks to their newfound FDA approval. It is also available in Germany, Hong Kong, Ireland and Switzerland.