FDA clears first medical accessory for the Apple Watch—an EKG sensor by Valentina Palladino
Plenty of studies boast about the medical possibilities of the Apple Watch, but Apple's wearable is a consumer device, not a medical one. However, the FDA just announced the clearing 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. An Apple Watch paired with a KardiaBand could provide users with an EKG reading in 30 seconds, detecting abnormal heart rhythm and atrial fibrillation and sending that information to a doctor for further analysis.
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The $199 device is an unassuming black band that attaches to the Apple Watch like other band accessories. On the band right below the Apple Watch module is the KardiaBand's silver sensor where users place their finger to take a reading. 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.
AliveCor's new SmartRhythm technology takes a more personalized approach to the prevention technology the Apple Watch already has. 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. If an abnormality is detected during the Apple Watch's continuous measurement of your heart rate, AliveCor and KardiaBand's app will prompt you to take an EKG reading. The Watch's display will then show the normal heart rate range that KardiaBand's technology estimated for you, the abnormal heart rate detected, and where the EKG reading falls in relation to that data.
The KardiaBand isn't AliveCor's first medical device—the company already sells KardiaMobile, a small, rectangular EKG reader that pairs with a mobile app that allows users to take quick EKG readings by laying two fingers on their sensor on the device. The KardiaBand makes this technology more discrete by making it into a tiny sensor that snaps into an Apple Watch band, making it accessible anywhere, anytime. EKG readers similar to KardiaMobile have been around for some time, but the KardiaBand is the first medical accessory cleared by the FDA for use with an Apple Watch.
The KardiaBand is relatively accessible at $199, and users can email and print EKG recordings for no extra cost. However, users must pay $99 per year for AliveCor's premium program if they want access to unlimited cloud storage and history, customized monthly reports shared with their doctor, and other perks.
The FDA has made an effort to collaborate with tech companies that want to make it easier to produce devices and software that consumers can use to monitor their health. Recently, Apple, Fitbit, Samsung, and Johnson & Johnson were announced as just a few of the companies participating in the FDA's precertification pilot program under its Digital Health Innovation Action Plan. All of the companies involved with this program will help the FDA set guidelines for approving health and medical software that devices can use. Instead of approving and further monitoring individual devices, the FDA appears to be more interested in the software that these devices run. The FDA will likely continue to monitor AliveCor's software for KardiaBand and any other consumer wearables it makes in the future.
Source: https://arstechnica.com/gadgets/2017/11/fda-approves-first-medical-accessory-for-the-apple-watch-an-ekg-sensor/