Bellabeat seeks FDA approval for Ivy fitness tracker

Women's health wearable wants regulatory approval
Bellabeat wants to become a medical company
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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.


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.