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December 6, 2017

FDA approves first medical device designed for the Apple Watch

Daily Briefing

    FDA has approved a medical device for the Apple Watch, called KardiaBand, that can take an electrocardiogram (ECG)—making it the first medical device designed for an Apple Watch that's been approved by the agency.

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    How it works

    According to AliveCor, the manufacturer behind the device, KardiaBand can record a clinical-grade ECG in 30 seconds when touch-activated by a user, who may then email out the results. AliveCor is marketing the device in conjunction with SmartRhythm, an Apple Watch program that tracks the watch's data on a user's heart rate and physical activity and prompts the user in real-time to take an ECG when it detects potential abnormalities.

    Consumers can buy KardiaBand for $199, a purchase that includes the ability to record unlimited ECGs and send them out by email. If users are interested in the SmartRhythm program, they can purchase it as part of AliveCor's KardiaGuard membership for an annual payment of $99. The membership enables consumers to save ECG recordings to the cloud and generates a monthly summary on the user's ECGs and various other readings. 

    According to AliveCor founder David Albert, neither the device nor the service membership require a prescription or are eligible for insurance reimbursement. However, if a doctor writes a prescription for one, patients are able to use a medical savings account to pay for it.

    Potential concerns

    The University of California-San Francisco's Ethan Weiss said the integral part of the package is "the rhythm alert which triggers the user to grab an ECG." He explained that among "people with cryptogenic stroke or post TIA (transient ischemic attack) or even very high risk (say, mitral stenosis or extremely-high CHA2DS2-VASc scores), this could be a very useful tool."

    That said, Weiss cited the potential risk for overdiagnosis or misdiagnosis if used to measure stroke risk among the general population. "I expect it will be used by many people in whom there is no indication, and that will lead to a lot of cardiologists trying to sort through a lot of data they don't understand," he said.

    The Mayo Clinic's Michael Joyner expressed similar concerns. "Measuring things is not therapy," he said. "So in terms of patient care applications, if this is not linked to a coherent way to deal with and act on the data, then any assumptions about better outcomes are premature. The well-done (randomized controlled trials) on things like (congestive heart failure) and home monitoring have not been especially impressive."

    Joyner also expressed doubt that the device could help people who are trying to boost their health. "The evidence that wearables consistently motivate positive and durable behavior change over time is pretty thin," he said. "Better technology per se is not going to solve complex systems and behavioral challenges" (Reuters, 11/30; Husten, MedPage Today, 11/30).

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