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Wearable Contraceptive Seeks for FDA Approval

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Female healthcare technology
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Female health technology or Femtech is a growing market with the aim to improve women’s health and quality of life. Birth control is a major area of interest in Femtech. As the traditional birth controls embark on their digital journey, healthcare technology like fertility and period tracking apps are gaining popularity.

There are Clue, Dot, Glow, Spot On, and many more. Nevertheless, Natural Cycles is the first and only US Food and Administration Agency (FDA) approved digital birth control. It is certified in the European Union (EU) as well.

Back in March 2020, this fertility awareness app has added new features to track Covid-19 symptoms. And now, the company is planning to hop on the wearable technology bandwagon. It has filed a premarket notification to FDA regarding the integration of its contraceptive app with wearables such as the Oura Ring.

What makes this healthcare technology different from the rhythm method?

The rhythm method works by manually calculating your ovulation dates based on your menstrual history. On the other hand, Natural Cycles uses basal body temperature (BBT) data to track your fertility.

This is because our body temperature will slightly increase during ovulation due to hormone fluctuations.

Paired with a proprietary algorithm that can learn your menstrual pattern, it can predict your fertile window in advance. This algorithm makes Natural Cycles a customized birth control method with a lower margin of error. It can thus save you all the calculations or charting which are both time and labour-intensive.

Merging with another healthcare technology- wearables

The existing app requires users to take their body temperature orally every morning and input the reading into the app. They will then know their daily fertility statuses in the form of red (fertile days) and green (non-fertile days).

All these BBT readings and past cycles will be in the company database. There is nothing complicated about using this app. But it is human nature to be forgetful at times.

Hence, this leads to the idea of pairing Natural Cycles with another healthcare technology – wearables such as the Oura Ring. Oura ring is a wedding-band-like personal fitness tracking device.

“We listened to our users, and they said, you know it would be great if there will be something they could wear and measure the temperature during the night so they don’t have to remember in the morning,” says Elina Berglund, co-founder and CEO of Natural Cycles. Right now, only 25% of Natural Cycles existing users can access this new feature through a beta program.

Fertility awareness app

Natural Cycles

The challenges

Like most healthcare technologies, challenges always exist. Wearables help users to get more accurate and constant BBT readings since the readings are taken continuously.

But whether these wearables are taking high-quality temperature measurements, it is still unclear. The company has yet to publish the data of a study done on the Oura Ring’s temperature readings.

Furthermore, pairing Natural Cycles with wearables does not make it a more comprehensive fertility awareness approach.

On the other hand, partnering with third-party wearables means there will be another set of the privacy policy. Users might get confused about their own privacy rights and where their data will be going.

The backslash against Natural Cycles

Natural Cycles claims to be 98% effective under perfect use and 93% effective under typical use. Stress-free, hormone-free, and non-invasive are the key selling points of this first certified digital contraceptive to date. However, controversies around its reliability and effectiveness remain unsolved. Natural Cycles was blamed for unwanted pregnancies in 2018.

An article came out in The Guardian a few months later, questioning the effectiveness of Natural Cycles. It seems like the shiny promises of this digital contraceptive might not work for everyone. For those with irregular menstruation cycle or sleep schedules, it is rather hard for the algorithm to do the prediction.

An unmet need for non-hormonal contraceptives

As more women are turning to non-hormonal contraceptives, experts expect future innovations in digital contraceptives with more high-quality research. As healthcare technology expands, perhaps one day we can trust our fertility awareness apps more. But do bear in mind that no form of birth control is fully effective.

 

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