Le Lézard
Classified in: Health, Science and technology
Subjects: WOM, FDA

FDA Releases Final Classification for Natural Cycles, the First and Only Birth Control App in the U.S.

NEW YORK, March 7, 2019 /PRNewswire/ -- The FDA (The Food and Drug Administration) has issued a final order to classify Natural Cycles as a Class II device. The FDA is a federal agency in the United States (US) that is responsible for protecting and promoting public health. In August 2018, Natural Cycles' application for De Novo classification as a Class II medical device was granted by the FDA, making Natural Cycles the first app cleared in the US as a form of birth control.

Following the 2018 clearance, Natural Cycles' classification as a Class II medical device has been in effect since the initial approval. The final order is the last part of the approval process that establishes the required special controls and officially codifies the new regulation for this type of technology. Since the initial FDA approval, Natural Cycles has been operating under these special controls.

"We are pleased that the FDA recognizes that digital health technologies can empower consumers to make better-informed decisions about their own health. As the first and only app to be cleared in the US as a form of birth control, this approval is setting the framework and guidance for future developments in this area," said Raoul Scherwitzl, PhD, CEO and co-founder, Natural Cycles. "We welcome the FDA's decision to encourage innovation while ensuring the safety and efficacy of digital health products, including mobile medical apps. Our mission at Natural Cycles is to pioneer women's health with research and passion, and this final milestone marks a very important step in that journey."

For further information, please refer to the official FDA statement.

About Natural Cycles

Natural Cycles was founded in June 2013 by former CERN physicist, Dr Elina Berglund and her husband Dr Raoul Scherwitzl, who also has a background in physics. Natural Cycles is an effective, natural method of contraception that is delivered in the form of an app. It uses a smart algorithm that is sensitive to subtle patterns in a woman's cycle to determine daily fertility, based on basal body temperature and period data. Natural Cycles is 93% effective with typical use1,  which means that 7 women out of 100 get pregnant during 1 year of use. Natural Cycles is the only app of its kind to be available in Europe and the US for use as a contraceptive. The app can also be used to help plan a pregnancy when the time is right. Natural Cycles' mission is to pioneer women's health with research and passion, by empowering every woman with the knowledge she needs to be in charge of her health. Natural Cycles is headquartered in Sweden and has operations in the United States, Germany, Switzerland and the United Kingdom.

Read more at: www.naturalcycles.com


1. Berglund Scherwitzl E, Lundberg O, Kopp Kallner H, Gemzell Danielsson K, Trussell J, Scherwitzl R. Perfect-use and typical-use Pearl Index of a contraceptive mobile app. Contraception. 2017;96(6):420-425.


SOURCE Natural Cycles

These press releases may also interest you

at 06:00
Ceribell, Inc announced the launch of Clarity, a new 24/7 bedside EEG monitoring and alerting technology, at the American Epileptology Society Annual Meeting.  Ceribell's Rapid Response EEG system made bedside EEG possible for critically ill patients...

at 06:00
Intelligent.com, a trusted resource for online degree rankings and higher education planning, has announced the Top 25 Doctorate in Psychology Degree Programs for 2020. The comprehensive research guide is based on an assessment of 148 accredited...

at 03:00
On one end of the humility spectrum, there's the braggers. It doesn't matter if all they've done is fry an egg without burning it - the entire world must know of their accomplishments. Next, there's the humble-braggers. They think they're being...

at 02:40
Janssen Biotech, Inc., a Janssen Pharmaceutical Company of Johnson & Johnson, announced today that it has entered a definitive agreement to acquire all rights to the investigational compound bermekimab from XBiotech Inc. Bermekimab is an...

6 déc 2019
BrainCo's prosthetic hand won Time Magazine's Top 100 Inventions of the Year. The prosthetic hand represents an advancement in assistive technology, providing amputees with an intuitively controlled prosthetic at a lower cost. ...

6 déc 2019
Helix BioPharma Corp. ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, today announced the voting results of the Company's annual and special meeting of...

News published on 7 march 2019 at 12:19 and distributed by: