FDA clears Natural Cycles as the first digital method of contraception in the US

Natural Cycles became the first and only app to receive FDA clearance as a method of birth control. The app contains an algorithm that calculates the ‘fertile window’ based on basal body temperature (BBT) and menstrual cycle information. It makes the women aware of her ‘fertile days’ to avoid sex or use a barrier method if practicing birth control.

Terri Cornelison, M.D., Ph.D., assistant director for the health of women in the FDA’s Center for Devices and Radiological Health said in a press release, "Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly." 

"But women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device," she added further.

“Natural Cycles can adapt to each woman’s body and, with a high degree of precision and accuracy, determine when she is ovulating,” says Dr. Elina Berglund, a physicist who created the app along with her husband Dr. Raoul Scherwitzl, a postdoctoral researcher.

Natural cycles is just like old times period tracker with some added features. The app requires the women to input her daily basal body temperature recordings and the date of menstruation. LH test result is an optional entry point.

The app’s calendar then labels fertile days as red (when you should abstain or use a condom) and the rest green, when you are “safe.” Using the sensitive thermometer and some mathematics the app claims itself “as good as the pill" at preventing pregnancy.

The app is primarily based on the fact that a woman’s body temperature rises slightly (about 0.4℃) after ovulation and remains slightly elevated throughout the rest of the cycle. The app uses an algorithm that considers body temperature, cycle irregularities, sperm survival, length of menstrual cycle and cycle irregularities. The algorithm learns from previously recorded cycles from the same woman and can provide predictions of her fertility status and upcoming ovulation, LH and menstruation days.

Initially, the app shows a nearly equal number of a green and red day but, as women continue using the app and fed more data, the number of red days is reduced to 8 each month. The app is 99.95% sure before it assigns a day red or green. If in doubt it will go red.

Clinical studies involving 15,570 women found that when used correctly, the failure rate for the app was 1.8%, while with typical use, or women sometimes not using the app correctly, the failure rate was 6.5%. "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 US," said Elina Berglund.

"Our mission at Natural Cycles is to pioneer women's health with research and passion, and this milestone marks a very important step in that journey."

Natural Cycles received CE mark last year for marketing in Europe and has more than 900,000 registered users worldwide.

Anyone can use it, even women with PCOD or irregular cycles, only these women will have more red days on the calendar than green. Natural Cycles is contraindicated in women in whom pregnancy poses a serious risk to mother or fetus or in those who use other forms of contraception that prevent ovulation.  The method also does not prevent STIs.

The Natural Cycles app can be purchased through the Apple store or Google Play on a yearly subscription basis for $79.99 a year (includes oral basal thermometer) or monthly for $9.99 per month. They also offer a free trial period of 1 month.

Here is a video about Natural Cycles app for healthcare professionals. 

Product Page

FDA press release

Ob/Gyn Updated Facebook page

iFertracker- First Overnight Basal Body Temperature tracker to monitor the fertility

iFertracker™ by Raaing Medical is the first overnight fertility monitor that measures the core body temperature continuously throughout the night. It also simultaneously calculates and record the Basal Body Temperature (BBT) to predict the fertile window.

Usually, to measure the BBT a woman must use a special thermometer to record the temperature early morning each day at the same time before she gets out of bed. This task itself is tiresome and unreliable, sometimes a day is missed, or some error might occur.

iFertracker eliminates all this hassle and does all the work while the woman can sleep soundly throughout the night. It comes in beautifully packaged, with two CR2025 batteries (each battery is predicted to last for 45-60 days so the other is kept as spare one), a battery replacement tool, and 150 double-sided, single-use adhesive patches.

Setting up the iFertracker before the woman can start measuring the temperature is a very easy task. The woman has to simply download the free app to an Android or iOS cell phone and input all her menstrual cycle details along with her biometrics.

The device itself is very small and lightweight and has a very sleek, oblong design. It powers on automatically as soon as it comes in contact with body heat and a small blue light starts flashing indicating that Bluetooth capabilities are enabled. After once connected the iFertracker will recognize the user’s cell phone and will connect with it every time the app is opened.

To begin using, the woman places a new, double-sided adhesive patch on the oblong wearable thermometer and adhere it to the armpit. It is advisable to shave the area before putting on the device. The device turns on by itself and collects 20,000 data points in a single night, continuously monitoring the temperature as the user sleeps through the night. These are eventually uploaded to cloud and analyzed by an advanced algorithm to calculate the BBT.

The next morning, she removes the device and goes around with her morning routine. At her convenience, she opens the app on her smartphone and the device sync to it and starts downloading the temperature readings collected overnight.

In an event that internet connectivity is lost, or the user is very busy to open the app, the device has the ability to store data up to 10 days and it syncs with the app as soon as it is opened.

The iFertracker app displays the information collected in the form of graphs that are user-friendly and easy to understand. The graph color codes each phase of the cycle, including Menstruation, Follicular & Luteal phases, Fertile Window, and Ovulation day.

In addition to the display of last night’s BBT, the home screen informs the user about her fertility possibility and days until ovulation. The app also allows the user to input relevant event such as cervical mucus, mood, sexual activity, etc. The accuracy of prediction increase linearly with the duration of use as the tracker collects data over time and harness it to predict the fertility window and day of ovulation.

Besides getting pregnant this information can be used for natural family planning, hormone tracking during pregnancy or return to full fertility after delivery.

Raiing Medical also manufacture iThermonitor ™, the only wearable, wireless, clinically validated, and non-invasive core temperature thermometer.  It is worn similar to iFertracker and can be used in children and adults.

The iFertracker is available on Amazon or directly from Raiing Medical for $109. The adhesive patches are also available separately. 

Product page

Here is a video about how to track your BBT using iFertracker

Ob/Gyn Updated Facebook page

A revolutionary personal fertility sensor that sends you a message- “You are about to ovulate”

A Medical Device Premier Innovation summit was held recently at Minneapolis, MN by MedTech Strategist in association with The Medical Alley Association. About more than 40 start-up and emerging medical companies presented their technologies and devices at the summit.

Among the display was “Priya”, a vaginal temperature sensor that is being developed to wirelessly capture your continuous core temperature to detect the subtle changes that occur PRIOR to ovulation. 

Priya is developed by Prima-Temp, a medical device and technology  company situated in Boulder, CO, USA.

Priya is currently undergoing clinical trials, the intravaginal ring directly sends the temperature data to Priya App on the patients’ smartphone. When the subtle fall in temperature before ovulation is detected, the smartphone alerts the women.

Priya is an intravaginal ring made from medical-grade silicone form-factor and have a wireless continuous temperature sensor inserted within it. It’s dimensions and flexibility are similar to Estring®. Women are using these contraceptive vaginal rings or estrogen containing rings since may years. Prima-Temp just replaced the medications with a very sensitive sensor that measures core body temperature. Currently an algorithm is being tested to detect the DIP in temperature prior to ovulation.

This device has no extra monitor, urine strips or other extra parts that needs to be attached or monitored. The patient only needs to pair the ring with the app on the smartphone and insert the ring in the vagina.

Unlike the Basal Body Temperature (BBT), Priya monitors the internal core temperature continuously, which has been shown to more precise than oral or skin temperature. Based on this continuous core monitoring, the algorithms developed for Priya have been shown to achieve a 99% sensitivity for detection of ovulation, with a 99% percent accuracy in clinical trials.

Women’s body shows a striking diurnal variation and exhibit a pattern that is has been established as highly reliable marker for circadian rhythm. This pattern shows a distinct dip in body temperature 48- hours period prior to ovulation which is detected by the continuous monitoring by the ring sensors.

World’s first app receives approval as a contraceptive in Europe, could it replace the pill?

Natural Cycles app.

Natural Cycles- is world’s first fertility control app that got a clearance in the European Union including U.K placing it alongside pills, IUDs, and condoms. Natural Cycles is a certified and CE marked medical device of class IIb, intended to be used for contraception.

Elina Berglund Scherwitzl

The app was created by Dr. Elina Berglund, 32, a physicist who was part of the team that found the Higgs boson at Cern in Switzerland, and her husband Dr. Raoul Scherwitzl, a postdoctoral researcher.

“Natural Cycles can adapt to each individual woman’s body and, with a high degree of precision and accuracy, determine when she is ovulating,” says Dr. Elina Berglund

Natural cycles is just like old times period tracker with some added features. Using a sensitive thermometer and some mathematics the app claims itself “as good as the pill" at preventing pregnancy.

The app requires the women to input her daily basal body temperature recordings and the date of menstruation. LH test result is an optional entry point.

The safe and unsafe days 

The app’s calendar then labels fertile days as red (when you should abstain or use a condom) and the rest green, when you’re “safe”.

The app is primarily based on the fact that a woman’s body temperature rises slightly (about 0.4℃)after ovulation and remains slightly elevated throughout the rest of the cycle. The app uses an algorithm that takes into account body temperature, cycle irregularities, sperm survival, length of menstrual cycle and cycle irregularities.  The algorithm learns from previously recorded cycles from the same woman and can provide predictions of her fertility status and upcoming ovulation, LH and menstruation days.

Initially, the app shows a nearly equal number of the green and red days but, as women continue using the app and fed more data, the number of red days are reduced to 8 each month. The app is 99.95% sure before it assigns a day red or green. If in doubt it will go red.

It can be used by anyone, even women with PCOD or irregular cycles, only these women will have more red days on the calendar than green.

efficacy of the app 

A recent clinical study published in the peer-reviewed European Journal of Contraception and Reproductive Health Care recruited 4000 women between ages 18-45 to use this app.[1] The study results showed that for every 100 women who used the app, 7 women got pregnant each year (7% failure rate). CDC statistics quote the failure rate for the pill is around 9%, for injectable contraceptive it’s 6%; for an IUD, it's 0.2% - 0.8%.

Kristina Gemzell Danielsson, from Swedish medical institute Karolinska Institutet. “The efficacy is far below that of intrauterine contraception or implants, but similar to that of the pill when used in real life. The pill which will celebrate its 56 birthdays in March 2017 was a breakthrough that liberated women and changed the way we look at sex.  

Could the app replace pill that has ruled for 56 years.

Natural cycles can help women to plan a pregnancy as well. It is especially useful for women with irregular cycles and PCOD. In fact, it has already helped 5000 Swedish women to conceive under the # HappyPregnant project. Elina Berglund has already launched a similar project in U.K.

The app is currently used by nearly 100,000 users in 161 countries, paying £6.99 per month.

Natural Cycles was first launched in 2014, in Stockholm and across Sweden.

The company aims to expand the team in the UK and internationally and to continue with more clinical studies and data analysis.

The app can be purchased here.

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[1] http://www.tandfonline.com/doi/full/10.3109/13625187.2016.1154143