Ava Announces FDA Clearance for Ava Fertility Tracker
Digital healthcare company Ava has announced it has received FDA clearance for its Ava Fertility Tracker, making it the first and only FDA-cleared fertility tracking wearable. Ava’s fertility tracking sensor bracelet and accompanying app, Ava Fertility Tracker, is already the first and only wearable machine learning device to aid women in ovulation prediction and facilitation of conception. The Ava Fertility Tracker has been shown in clinical studies to detect the fertile window in real-time. The most recent results are published in the peer-reviewed Journal of Medical Internet Research and confirm changes to five physiological signals of fertility throughout the menstrual cycle. Ava tracks all five.
How the Ava Fertility Tracker Works
Digital tools like the Ava Fertility Tracker challenge the traditional way of health care. These technologies facilitate innovative methods and modalities to improve health care, enable lifestyle change, and create efficiencies are progressing quickly. Ava’s sensor bracelet collects data 25 times per second while the user is asleep. In the morning, the user syncs the data to the Ava app. As it records the user’s physiological parameters, it also tracks movement with a built-in accelerometer. This information is then analyzed to pinpoint the fertile window in real-time using four different algorithms. The devices also measure sleep quantity (duration) and quality (percentage of combined deep and REM sleep). These algorithms were validated in a clinical trial conducted at the University Hospital Zurich in Switzerland. It showed the following performance when identifying fertile days in real-time:
- Accuracy: 89%
- Sensitivity: 77%
- Specificity: 92%
- The average number of days detected in the fertile window: 5.3
Temperature-based methods of fertility tracking only identify ovulation after the fact, when a woman is no longer fertile. And many temperature-based methods of fertility tracking require that a woman wake up at the same time every morning to take her temperature. As a wearable, Ava collects temperature data – jointly with various other physiological parameters – much more conveniently. And because it measures temperature continuously throughout the night, our data showed that it is more sensitive to detecting post-ovulatory temperature shifts.Maureen Cronin, Ava Chief Medical Officer
Research and FDA Clearance – The Ava Fertility Tracker
The device was successfully certified under the new European Device Regulation (MDR). Now, backed by the FDA clearance of its 501(k) application, Ava can also point to the Ava Fertility Tracker’s efficacy as comparable to time-trusted methods.
Ava’s clinical science team is actively engaged in research related to women’s healthcare across their entire reproductive lifetime. To gain FDA clearance, Ava submitted multiple performance tests, including a prospective clinical trial demonstrating that the Ava Fertility Tracker accurately predicted the day of ovulation. Results indicated that the Ava Fertility Tracker predicted the day of ovulation in a woman’s cycle just as well as urinary LH tests. The research also demonstrated that the Ava Fertility Tracker detected significantly more post-ovulatory temperature shifts than other publicly available temperature-based ovulation detection products.
The FDA clearance validates Ava’s efficacy as comparable or superior to standard products found in every pharmacy. However, Ava offers significant advantages over other fertility tracking methods. Not only is Ava easier and less invasive than having to pee on multiple sticks throughout the month but, we also detect more fertile days in a woman’s cycle, giving her more time (and increased chances) to conceive. For example, LH tests only provide around 24 hours of advance ovulation warning, even though a woman is most fertile the three days preceding ovulation. Ava allows users to take advantage of more of the fertile window.Maureen Cronin, Ava Chief Medical Officer
Ava is interested in clinical and research cooperation in gynecology, obstetrics, and adjacent fields. Striving to make Ava a global leader in the field of women’s health, our scientists are pursuing projects related to:
- Natural birth control / contraception
- Irregular cycles & Polycystic ovary syndrome (PCOS)
- Pregnancy complications
- Reproductive Endocrinology
Ava is a digital health company with offices in Zurich, San Francisco, Belgrade and Makati that advances women’s reproductive health by bringing together artificial intelligence and clinical research. Its fertility tracking sensor bracelet detects the five most fertile days of a woman’s cycle in real-time with 90% accuracy, while also delivering personalized insight about reproductive health and pregnancy. Worn only during sleep, the Ava Fertility Tracker multiple physiological parameters including pulse rate, breathing rate, and skin temperature. Launched in the US in 2016, the Ava bracelet is now sold in 36 countries and has helped around 40,000 women become pregnant. Studies for the clinical use of Ava have been conducted in collaboration with academic partners around the world, including at the University Hospital of Zurich, Switzerland, Columbia University, and Northwestern University’s Feinberg School of Medicine. Ava was voted Best of Baby Tech at CES, named a Women’s Health “Editors’ Choice” product and has been honored as a CB Insights Digital Health 150 company. For more information on Ava, visit www.avawomen.com.