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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.

Mental health

Cosmetic procedures may become addictive for some women, researchers say

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Cosmetic procedures may become addiction-like for some women, with low body esteem and problematic social media use linked to higher risk, new research suggests.

A study of 1,614 women aged 25 to 71 found that one in five who had undergone treatments met the threshold for moderate to severe risk of addictive cosmetic procedure use.

Low body esteem and problematic social media use emerged as the strongest risk factors.

Researchers from the Hebrew University of Jerusalem and the Israel Center for Addiction and Mental Health examined what they described as addictive cosmetic procedure use, or ACPU, among Jewish Israeli women.

ACPU refers to repeated cosmetic treatment behaviour that may resemble addiction, including feeling unable to stop, continuing despite negative effects or craving further procedures.

The study was led by Vera Skvirsky alongside Uri Lifshin, Dvora Shmulewitz and Mario Mikulincer, from the department of psychology at the Hebrew University of Jerusalem and the Israel Center for Addiction and Mental Health.

The researchers surveyed women from the general population rather than focusing only on patients at cosmetic clinics.

Among women who had undergone cosmetic procedures, 20 per cent met the threshold for moderate to severe lifetime risk, while more than 15 per cent reported symptoms within the previous year.

Across the full sample, nearly nine per cent of women showed moderate to severe signs of problematic cosmetic procedure use.

The researchers adapted questions based on mental health criteria used to assess substance-related disorders.

Participants were asked whether they had tried unsuccessfully to stop having cosmetic procedures, felt compelled to continue despite negative consequences or experienced cravings linked to treatment.

Previous research has linked cosmetic procedures with body-image concerns and body dysmorphic disorder.

Body dysmorphic disorder is a mental health condition in which a person becomes highly distressed by perceived flaws in their appearance, often flaws that others may not notice.

The new study examined whether repeated cosmetic procedures may, in some cases, resemble a behavioural addiction.

Women with lower body esteem were more likely to report addiction-like patterns, particularly when this was combined with high levels of problematic social media use.

Participants who reported problematic or excessive social media behaviour appeared especially vulnerable when they also felt dissatisfied with their appearance.

The researchers also found smaller links between addictive cosmetic procedure use and lower feminist attitudes, lower attachment security and more negative attitudes towards ageing.

However, those links were less consistent when several factors were analysed together.

The findings come amid a sharp global rise in cosmetic procedures, with international estimates cited by the researchers suggesting interventions increased by around 40 per cent between 2019 and 2023.

The researchers stressed that the study does not suggest cosmetic procedures are inherently harmful.

Instead, they said repeated engagement may, for some people, take on characteristics similar to behavioural addictions already recognised in mental health research.

The researchers said: “Cosmetic procedures have become deeply normalised in many societies, and for many people they may be a positive experience.

“But our findings suggest that for a meaningful minority, the behaviour may begin to resemble other compulsive patterns we see in addiction research, especially when low body esteem and problematic social media use are involved.”

The study was cross-sectional, meaning it captured a single point in time and cannot prove cause and effect.

Researchers said it remains unclear whether problematic social media use contributes to addiction-like cosmetic procedure behaviour, whether treatments influence body image and online engagement, or whether other psychological factors drive both.

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New pregnancy treatment shows promise for at-risk twins

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A high-powered ultrasound treatment could help identical twins affected by a rare and serious condition during early pregnancy, an initial study suggests.

Twin-to-twin transfusion syndrome, or TTTS, causes uneven blood flow between identical twins who share a placenta.

The imbalance can leave one baby dangerously small and the other too large, putting both babies’ survival at risk.

 

Brioney Garrett’s daughters were in danger before doctors used the world-first treatment to seal the blood vessels causing the problem without an operation.

Nancy and Margo were born healthy and, now aged four, are due to start school.

Researchers from Queen Charlotte’s and Chelsea Hospital tested the non-invasive procedure in 10 women from the UK and elsewhere in Europe after scans detected TTTS during early pregnancy.

Five women needed further treatment, while 12 of the 20 babies survived following the procedure.

The researchers described having a treatment that did not require a needle or telescope to be inserted into the mother’s abdomen as “extremely exciting”.

However, they said larger studies involving more pregnant women were needed before the procedure could be offered more widely.

Garrett described her daughters as “my miracle twins”.

She said: “We were in a very dire situation and I don’t forget that.

“It stays with me always how things could have been. Every day I still count my blessings.”

TTTS affects between 10 and 15 per cent of identical twins who share a placenta, representing around 300 to 400 pregnancies in the UK each year.

The uneven blood flow causes excess fluid to build up around the larger recipient baby, while leaving dangerously little fluid around the smaller donor baby.

Treatment usually involves inserting a needle into the womb to drain some of the fluid or using a laser to seal the connecting blood vessels.

Garrett’s procedure took about 20 minutes. She lay flat while a specially designed machine directed high-powered ultrasound waves at small blood vessels in her placenta.

She said: “It was very quick and pretty painless.”

Christoph Lees, head of fetal medicine at Imperial College Healthcare NHS Trust and professor of obstetrics at Imperial College London, described the research as “very promising”.

He said: “If this could work in a fully-fledged study, it could give hope to a lot of women who otherwise might have to have quite invasive treatment.”

Ultrasound is commonly used during medical scans to produce images of the body, but this procedure uses much more focused waves.

Heat generated by the waves can seal blood vessels about 2mm in diameter and located around 5cm to 6cm beneath the skin.

The procedure blocked blood flow in 90 per cent of the vessels treated during the study, with no unwanted side-effects reported.

Twins Trust, which supported the study, said the approach could make a significant difference for families affected by TTTS.

Helen Peck, head of healthcare engagement and research, said: “Any procedure that is non-invasive and can potentially identify TTTS earlier and improve outcomes for our families with this life-threatening condition could be a turning point.”

Scans carried out weeks after Garrett’s procedure showed that blood flow between the babies had been rebalanced, although other problems developed during the pregnancy.

Garrett said Margo, who had too little fluid around her, “was in a much better position” and that “the strain on Nancy’s heart had eased”.

Nancy and Margo were born at nearly 34 weeks, weighing 3lb 7oz and 3lb 3oz respectively.

Garrett said: “They were both healthy, and Margo wasn’t as small as we worried she was going to be.”

The twins are due to start primary school in September.

Garrett said: “They’re funny, smart, energetic little girls that just fit right in with their age group.”

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Breast cancer rising rapidly in Asian American women, study finds

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Breast cancer rates have risen rapidly among Asian American women over the past two decades, with some of the steepest increases among women under 50, new research has revealed.

Rates rose by more than three per cent a year in nearly every Asian American ethnic group studied, much faster than in any other US ethnic group.

The increase was particularly marked among women under 50 and in cases involving advanced-stage disease or certain aggressive subtypes of the cancer.

The study found even larger increases among Chinese and Vietnamese women.

Breast cancer rates among Native Hawaiian women were already among the highest recorded among US women, but rose by about one per cent a year, less than the increases seen in Asian American groups.

The researchers said increased screening was unlikely to explain the trend because screening would be expected to identify more cancers at an earlier stage.

Instead, cancers that had already spread increased at the fastest rate.

Triple-negative breast cancer, considered the most aggressive subtype, rose by more than six per cent a year among Chinese American women between 2017 and 2022.

Scarlett Lin Gomez, senior author and professor of epidemiology and biostatistics at the University of California, San Francisco, said: “These patterns are highly concerning from a disparities standpoint.

“They underscore why it is so important to move beyond treating Asian Americans, Native Hawaiians, and Pacific Islanders as a single population.”

Researchers analysed about 150,000 cases of invasive breast cancer diagnosed between 2000 and 2022 using data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results Programme.

The analysis covered nine Asian American, Native Hawaiian and Pacific Islander populations across 14 states. Together, these states account for about two-thirds of the US population within these groups.

Except for Native Hawaiian women, Asian American women have historically had lower breast cancer rates than non-Hispanic white women.

However, the gap has narrowed rapidly. By 2022, incidence among Asian American women under 50 was comparable with that recorded among white women.

The reasons for the increase among women under 50 remain unclear.

Changes in reproductive patterns, diet and other lifestyle factors may play a part, but researchers said they did not fully explain the findings.

They said previously unidentified risk factors may also be contributing to the rises in some Asian American communities.

Researchers hope two UCSF-based studies, the CRANE breast cancer study and the ASPIRE cohort study, will provide insights into these factors.

Gomez said: “Understanding why breast cancer is increasing so rapidly in these communities is critical.

“At the same time, we need to ensure that women across all Asian American, Native Hawaiian, and Pacific Islander communities have access to culturally appropriate education, screening, and timely follow-up care.”

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