The topic FDA finally backs down with its blood pressure complaints against this wearable is currently the subject of lively discussion — readers and analysts are keeping a close eye on developments.
This is taking place in a dynamic environment: companies’ decisions and competitors’ reactions can quickly change the picture.
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For as much as we might love fitness wearables that are just utterly packed with sensors, manufacturers of these devices need to be very careful about whether all that data they’re gathering ends up classifying them as a “medical device” in the eyes of the FDA — and correspondingly, opening them up to that much more scrutiny. Last summer, we learned that the FDA was not happy about how WHOOP’s MG (Medical Grade) wearable was attempting to offer blood pressure analysis. Now, 10 months later, the government has finally worked things out with WHOOP.
according to the data Bloomberg, the FDA formally gave WHOOP the go-ahead for continuing to offer its blood pressure tool earlier this week. While the agency first warned the company about its concerns last August, WHOOP immediately pushed back, and never actually ended up disabling blood pressure support.
Ever since then, the two have reportedly been in negotiation over the agency’s concerns. Like many other wearables, WHOOP’s band isn’t able to measure blood pressure directly. Instead, users need to initially take measurements with a proper, inflatable blood pressure cuff. Once the app has this baseline, it attempts to extrapolate blood pressure changes based on measurements it actually can perform with its sensors.
In order to make the FDA happy, WHOOP is removing labeling in the app that flagged blood pressure as either normal or elevated, and switching to language that frames the tool’s purpose as providing wellness insights, rather than doing any kind of medical diagnosis.
That may sound like splitting hairs, but we’re sure that WHOOP users are happy to learn that this whole saga is no longer hanging over them, with the threat that blood pressure tracking might ultimately be removed entirely. The WHOOP MG is the company’s higher-end offering, available only as part of its “Life” plan, starting at $359 a year.
Now we’re just curious if the open source WHOOP alternative app Goose might ever build out a blood pressure estimation system of its own, offering this data without such a financial burden.
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