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Natural Cycles gets FDA clearance to integrate birth control app with Apple Watch data

Users who own an Apple Watch Series 8, 9, Ultra, or Ultra 2 will be able to import their temperature data from their watch

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The fertility-tracking app Natural Cycles has received clearance from the US Food and Drug Administration (FDA) for its use of wrist temperature data from Apple Watch.

The Natural Cycles app is used to help women plan or prevent a pregnancy “naturally”. There are six days each cycle a woman can become pregnant and the app, its developers say, uses an algorithm that analyses daily hormone-driven temperature changes to confirm if the user is fertile that day or not.

To receive their daily fertility status, users can manually take their body temperature or sync temperature data from a wearable device.

With the latest Apple Watch integration, Natural Cycles says users who own an Apple Watch Series 8, 9, Ultra, or Ultra 2 will be able to import their temperature data straight from their device.

Dr Elina Berglund Scherwitzl, Natural Cycles co-founder and CEO, said: “Immediately following the addition of temperature-sensing capabilities to Apple Watch Series 8 and Apple Watch Ultra, our users began asking for this integration so our team began clinical evaluations to validate the quality of the wrist temperature data to determine whether we could deliver Natural Cycles birth control using data from Apple Watch.

“We were thrilled with the results, submitted them to the FDA, and with this clearance are excited to give our users the ability to seamlessly measure using a device many already own and love.

“At a time when birth control accessibility has never been more important, we’re excited to give millions of women who already own a supported Apple Watch access to deeper fertility insights.”

In September 2022, Apple introduced temperature-sensing capabilities to Apple Watch with the release of Apple Watch Series 8 and Apple Watch Ultra.

The smart watch uses the temperature-sensing capabilities to enable users to receive retrospective ovulation estimates and period predictions. However, Apple’s cycle tracking experience is not intended to be used as a form of birth control.

Natural Cycles is currently the only app that has been cleared by the FDA to be used and marketed as birth control.

It received clearance to be marketed as birth control in 2018 through the FDA’s de novo premarket review pathway and was certified in the European Union in 2017. In the UK, however, the NHS does not recommend the app as a birth control method.

While Natural Cycles claims a typical use effectiveness rate of 93 per cent and a perfect use effectiveness of 98 per cent, some argue that the body’s basal temperature must be taken carefully for the algorithm to be correct, and for the app’s result to be effective.

Jana Abelovska, a superintendent pharmacist at Click Pharmacy, encourages users to use the app alongside condoms for extra protection.

“If users miss a temperature reading close to their predicted fertility window, barrier contraception, such as condoms, should be used to avoid accidental pregnancy,” Abelovska told the Independent.

Pregnancy

FDA clears “innovative” maternal and foetal monitoring device

The device measures the electrical activity of the body and extracts maternal and foetal heart rate via cloud-based processing

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The US FDA has granted clearance to a maternal and foetal monitoring device capable of measuring the electrical activity of the body.

The product, developed by the California-based maternal health company Bloomlife, is a prescription-based wearable device that aims to help healthcare providers measure maternal and foetal heart rate.

The device measures the electrical activity of the body and extracts maternal and foetal heart rate via cloud-based processing.

“Our pioneering consumer pregnancy tracker proved that women want access to more information during a pivotal time of her life,” said Eric Dy, co-founder and CEO of Bloomlife.

“The FDA clearance of Bloomlife MFM-Pro marks an important milestone by cementing our transition from consumer to medical markets.”

Earlier this year the WHO published its latest Trends in Maternal Mortality 2000 to 2020, which showed globally that in 2020 a woman died every two minutes due to pregnancy or childbirth complications. These trends are not limited to the developing world.

Before, during and after childbirth, women in the US are dying at a higher rate from pregnancy-related causes than in any other developed nation.

Increasing rates of high risk pregnancies demand greater clinical support, while decades long shortages of maternal health providers create barriers to care affecting urban and rural communities alike.

Bloomlife says it believes there is a role for technology to play in addressing this global maternal health crisis. The company aims to use technology to shift care from clinical settings to the home to deliver low-cost, “evidence-based” care.

“Covid revealed a significant amount of maternal care can be done outside of clinical settings. However, there remains a need to augment basic telehealth appointments with objective physiological data,” Dy explained.

“Utilisation of connected care solutions can not only increase the quality of virtual appointments, but allow us to build a more efficient, equitable and scalable means of screening and managing the health of mum and baby.”

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AI technology could detect pregnancy-related heart disease

A digital stethoscope has been shown to identify twice as many cases of peripartum cardiomyopathy as compared to regular care

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An AI-enabled digital stethoscope could detect pregnancy-related heart disease, new research has shown.

The study, conducted by Mayo Clinic, has found that an AI-enabled digital stethoscope could improve the diagnosis of peripartum cardiomyopathy, a potentially life-threatening and treatable condition that weakens the heart muscle of women during pregnancy or in the months after giving birth.

Researchers used the AI-enabled digital stethoscope that captures electrocardiogram (EKG) data and heart sounds to identify twice as many cases of peripartum cardiomyopathy as compared to regular care.

“We demonstrated for the first time in an obstetric population that AI-guided screening using a digital stethoscope improved the diagnosis of this potentially life-threatening and treatable condition,” explained lead study author Demilade A. Adedinsewo, an assistant professor of medicine in the department of cardiovascular medicine at Mayo Clinic in Jacksonville, Florida.

“This research can change current clinical practice from one that is reactive and symptom-driven to a more proactive approach of identifying pregnancy-related cardiac dysfunction using a simple, low-cost and effective screening tool.

“Earlier diagnosis would facilitate prompt and appropriate management of cardiomyopathy and reduce associated disease and death.”

Peripartum cardiomyopathy is a type of heart failure that can affect women late in pregnancy or after pregnancy. The disease weakens the heart, resulting in a decrease in the amount of blood that is pumped from the heart to other parts of the body.

It is typically diagnosed towards the end of pregnancy or in the months following and may be difficult for health professionals to detect because many of the symptoms are similar to those seen with normal pregnancy, such as shortness of breath and swelling in the feet and legs, according to the American Heart Association.

The rate of peripartum cardiomyopathy is somewhat low in the US, affecting one in every 1,000 to 4,000 pregnancies. However, it is more prevalent in countries like Nigeria, which has the highest reported incidence of peripartum cardiomyopathy worldwide, with it impacting as many as one in 96 pregnancies.

As part of the study, researchers from Mayo Clinic looked at almost 1,200 Nigerian women who were pregnant or had recently had a baby.

Approximately half were evaluated with AI-guided screening using the digital stethoscope and half received usual obstetric care in addition to a clinical EKG. Peripartum cardiomyopathy was detected twice as often among study participants when EKG testing was performed with a digital stethoscope using an AI algorithm, compared to clinical EKG in addition to routine obstetric care.

Overall, four per cent of the pregnant and postpartum women in the intervention arm of the clinical trial had cardiomyopathy compared to two per cent in the control arm, suggesting that half are likely undetected with usual care.

“While we expected AI-guided screening to improve the diagnosis of cardiomyopathy, we did not anticipate the frequency of cardiomyopathy diagnosis would be doubled,” Adedinsewo said.

She added: “Additional large trials enrolling a diverse group of women in other geographic locations are needed to evaluate the impact of AI-guided screening on cardiomyopathy diagnosis as well as its impact on adverse maternal outcomes.”

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From OB/GYN to entrepreneur: the Kenyan doctor rethinking maternal health

Maternal and newborn deaths are still a major public health problem in Kenya

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Dr Lorraine Muluka, OB-GYN and founder of Malaica

Kenya has one of the highest maternal mortality rates in the world. In 2020, the maternal mortality ratio in the East African country was 530 deaths per 100,000 live births – much higher than the global average of 223 maternal deaths per 100,000 live births. The ratio of babies who die in the first month of life is also higher than the global average.

However, as Dr Lorraine Muluka, a Nairobi-based OB-GYN and founder of the health tech start-up Malaica, has found out, most of these deaths can be prevented if women have access to safe and affordable maternal health services.

Here, the consultant-turned-entrepreneur tells us why she thinks innovation will prove to be essential in bridging the health gaps in the Kenyan healthcare system.

Hi Lorraine, could you tell us a bit more about your background?

My name is Dr Lorraine Muluka and I am an OB-GYN. I am also the co-founder and CEO of Malaica, a health tech start-up that focuses on maternal health in Kenya. I hold a master’s degree in medicine in obstetrics and gynaecology from the University of Nairobi and have worked in various private and mission hospitals in Kenya’s maternal healthcare sector.

Over the past decade, I have been involved in several healthcare start-ups, driven by my passion for innovating and improving the Kenyan healthcare system. I have also been practising as a consultant obstetrician at my private practice in Nairobi. In 2021, I decided to fully commit to my vision of improving maternal health in Kenya by co-founding Malaica.

What inspired you to create Malaica?

The birth of Malaica was driven by a shared passion by the co-founders for safe motherhood and an aspiration to transform the narrative of maternal and neonatal mortality ratios in Sub-Saharan Africa.

Personally, as an OB-GYN several times it was very frustrating seeing mothers lose their lives to preventable causes. A need to fix the gaps and delays in maternal healthcare that lead to poor pregnancy outcomes is at the core of Malaica and the inspiration behind its creation.

The delays women experience begin with a woman’s decision to seek care, extend to her access to the appropriate healthcare facility and also the quality of care she receives once there. These gaps result from the various challenges women face which include limited access to quality care, lack of continuous support and high healthcare costs among others.

By recognising and addressing these gaps, Malaica aims to provide a holistic, affordable, and supportive environment for expectant mothers, ultimately improving maternal and neonatal health outcomes.

How would you describe Malaica in a few words?

Malaica provides a dedicated online support team for expectant mothers, making the journey of pregnancy happier, more affordable, and safer. With Malaica by their side, expectant mothers can rely on the invaluable companionship and guidance they need throughout their pregnancy.

What makes Malaica different?

Malaica offers a unique approach to pregnancy support that focuses on the holistic wellbeing of expectant mothers, including physical health, mental wellness, and delivery readiness. Our online platform offers personalised care for each woman at an affordable cost, with a personal nurse midwife assigned to provide support throughout pregnancy.

We provide access to obstetricians/gynaecologists, educational content, and a nurturing online community moderated by supamums for peer support. In Nairobi, we offer both virtual and in-person ANC clinics and birth preparation classes.

What sets us apart is our unwavering empathy, creating a warm and supportive environment for expectant mothers. Malaica adapts to evolving needs, making us the ideal choice for pregnancy support.

Women’s health comes with a lot of stigma. How has this impacted you as a founder?

In all my years of practising medicine, especially in obstetrics and gynaecology, I have noticed that there is a lot of stigma surrounding women’s health, especially during pregnancy. This stigma can take many forms, from societal taboos to misunderstandings about women’s health issues. Sometimes, it’s challenging to remove these barriers and create an open and supportive environment where soon-to-be mothers can access the care and assistance they need.

However, this awareness of the problem has become a powerful motivation for me. It has encouraged me to work even harder to break down these obstacles and create a safe space where women can receive the care and support, they require without being judged. It has reinforced Malaica’s commitment to empathy and understanding, ensuring that we remain a platform that is free from stigma, where mothers-to-be can access the care and guidance they need with dignity and respect.

What obstacles have you encountered on this journey?

As pioneers in the industry, we face a unique set of challenges as a remote company. One of our main challenges is proving to potential clients that our services are genuine and essential. We also strive to provide high-quality care while managing costs, which can be difficult for affordable programs like Malaica’s.

Providing physical services in remote or underserved areas poses a logistical challenge, especially considering the competitiveness of the healthcare and pregnancy support industry. Many other providers are offering similar services, so we must work hard to stand out.

As a tech company, we require ongoing technological investments and cybersecurity measures to maintain a reliable online platform for our subscription program and telehealth services.

Another challenge we face is health education. Educating expectant mothers about the importance of maternal health and the services available to them can be difficult, particularly in areas with limited health literacy.

Finally, ensuring the financial sustainability of the business, especially when offering affordable subscription programs, can be quite challenging. However, social enterprises like Malaica play a vital role in improving maternal health and supporting expectant mothers. Our dedication to our mission can lead to positive outcomes for both the business and the community it serves.

What lessons have you learned?

My journey as the founder of Malaica has taught me several vital lessons. I’ve come to understand that empathy is the cornerstone of effective support for mums-to-be. Recognising the diversity of experiences among our users and tailoring our services accordingly is crucial.

Building a strong community of support through supamums and support groups is powerful. The world of women’s health is ever-evolving, necessitating continuous adaptation and improvement.

Challenging the stigma surrounding women’s health is essential, and affordability should never be compromised. Collaboration with experts enhances the quality of care, and unwavering passion fuels dedication to our mission. These lessons guide our commitment to making pregnancy safe, convenient, and stigma-free for women worldwide.

Where are you with Malaica now?

Malaica has come a long way since its inception. We are now a reliable and easily accessible online platform for pregnancy support services, with a reach across the nation. Our commitment to providing comprehensive care, including access to nurse midwives, specialists like gynaecologists, paediatricians, psychologists, and support groups, has cemented our position as a go-to resource for expecting mothers. We strive to eliminate the stigma surrounding women’s health and continue to evolve and grow.

Malaica’s commitment to affordability and inclusivity ensures that we remain a beacon of support for women worldwide. Although our journey is ongoing, we are proud of the progress we have made.

Where do you see the company in the future?

We are committed to expanding Malaica’s reach and improving the pregnancy journey for expectant mothers in Kenya and beyond. Our ultimate goal is to ensure that even more mothers have access to better support and care throughout their pregnancy.

As a health tech company, we will continue to leverage advanced technology for telehealth services, making our services more accessible and convenient, especially for mothers in remote areas.

We also aim to foster connections among mothers and provide a strong network of emotional support through our expanding community of expectant mothers. Additionally, we are building partnerships with healthcare institutions, NGOs, and government bodies to strengthen our impact on maternal health and reach underserved populations.

Education and advocacy are major challenges in the pregnancy healthcare space, and we will continue to engage in initiatives that raise awareness about maternal health issues and promote healthy pregnancy practices.

Overall, we are optimistic about Malaica’s future as we adapt to the changing healthcare landscape and provide essential support to expectant mothers.

 

Dr Lorraine Muluka holds a master’s degree in medicine with a specialisation in obstetrics and gynaecology. Driven by a passion for improving the Kenyan healthcare system through innovation, Dr Muluka has played significant roles in several healthcare start-ups over the past decade, while also maintaining her role as a consultant obstetrician at her private practice in Nairobi. At the end of 2021, Muluka co-founded the health tech start-up Malaica. She is currently serving as the CEO of the company.

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