Bellabeat seeks FDA approval for Ivy fitness tracker

Women's health wearable wants regulatory approval
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Bellabeat has announced that it’s applied its Ivy tracker approved by the FDA as a medical grade device.

The Bellabeat Ivy is a fitness tracker for women, designed specifically to monitor female health. It’s uniquely designed as a piece of jewelry, just like Bellabeat’s usual trackers, and looks like any bracelet.

The Bellabeat Ivy’s focus is on using the sensors to track metrics such as menstrual cycle, fertility, postpartum depression, menopause symptoms – as well as general wellness and activity.

The device uses a heart rate monitor, which keeps tabs on resting heart rate, respiratory rate and cardiac coherence. It also produced a Readiness Score, as is the fashion at the moment, with Fitbit, Garmin, Whoop and Oura all doing the same.

WareableBellabeat seeks FDA approval for Ivy fitness tracker

And with FDA approval, Bellabeat is hoping that the Ivy will, be used in medical settings – to help doctors and medical professionals monitor female patients.

Bellabeat is still in the very early stages of its approval process – and is gathering the data needed for its FDA application.

Many companies have become unstuck looking for FDA approval – most notably Withings, which waited years for approval for its Withings ScanWatch and Withings Move ECG in the US. That was eventually granted, but required large scale studies to be undertaken, which can take years.

And that fact hasn’t escaped Bellabeat. Urška Sršen, co-founder of Bellabeat said:

“We understand that the approval and certification process for medical devices in the United States can take up five years and are taking care with our trials to ensure that there are no foreseeable delays.”

However, Bellabeat is clearly looking to move out of simple consumer tracking and stake its claim as a leader in women’s wellness and health tracking – and with so few competitors – it’s got a great chance.


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James Stables

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James is the co-founder of Wareable, and he has been a technology journalist for 15 years.

He started his career at Future Publishing, James became the features editor of T3 Magazine and T3.com and was a regular contributor to TechRadar – before leaving Future Publishing to found Wareable in 2014.

James has been at the helm of Wareable since 2014 and has become one of the leading experts in wearable technologies globally. He has reviewed, tested, and covered pretty much every wearable on the market, and is passionate about the evolving industry, and wearables helping people achieve healthier and happier lives.


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