Mobile app created to prevent pregnancy gets FDA approval

16 August, 2018, 21:01 | Author: Veronica Peterson
  • FDA approves 'Natural Cycles' birth control app

The Swedish app, Natural Cycles, which is already certified for contraception in the European Union, requires women to take their temperature daily using a basal body thermometer immediately upon waking up in the morning, and enter the reading into the app.

Using data like daily body temperature and monthly menstrual cycle tracking, the app is said to have a fail rate of almost 2% for "perfect use", and a fail rate of 6% for "typical use", not unlike barrier methods and the pill. It is a mobile-based app that is used in combination with a conventional basal thermometer to identify ovulation and, hence, the fertile window. Natural Cycles is the only app to be cleared by the FDA and CE marked in Europe for use as a contraceptive, and its typical use effectiveness rate of 93% is supported by clinical data. It is based on daily body temperature readings and menstrual cycle information.

Cornelison also stated that "women should know that no form of contraception works perfectly".

"We are aware of a significant number of women in the USA looking for alternative, effective natural methods of birth control", said Juan Acuna, M.D., Associate Professor of OBGYN, Department Chair at Florida International University College of Medicine.

However, officials in Britain and Sweden launched investigations into the app earlier this year after receiving reports that women using it became pregnant.

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The app costs $79.99 per year and includes an oral basal thermometer, according to the website of the company, Natural Cycles Nordic AB. Natural Cycles does not provide protection against sexually transmitted infections.

"Based on the strength of our clinical data, we are delighted that the FDA granted De Novo classification for Natural Cycles and look forward to working together with healthcare professionals to offer a digital form of birth control to women in the United States", said Elina Berglund, PhD, CTO and co-founder, Natural Cycles.

The FDA confirmed the approval of the "contraception" designation for the mobile app "Natural Cycles" last week, which bills itself as providing an "algorithm that accurately detects and predicts ovulation and fertility". This action also creates a new regulatory classification, which means that subsequent devices with the same intended use may go through the FDA's 510 (k) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

But Natural Cycles co-founder Raoul Schewitzl told Business Insider those numbers were expected, because sometimes people don't follow the app's directions exactly.



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