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Flo Health denies claims it unlawfully shared app users’ data with Meta

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Europe’s first femtech ‘unicorn’ has denied claims that it unlawfully shared users’ personal data with the social media platform Meta.

The period-tracking app Flo Health is facing a possible multi-million dollar data privacy lawsuit in the US, accused of unlawfully sharing app users’ personal data with Meta for targeted advertising.

The case, which is taking place in San Francisco, began on Monday, 21 July and involves five named claimants who say they did not permit personal data, including the dates and lengths of the periods, to be shared with the social media platform, Sifted reports.

Flo Health denies all of the claims made against it, and Meta, which is also on trial, denies receiving any sensitive data from the company. 

Flo Health is considered to be Europe’s first FemTech unicorn after raising $230 million (£155.7m) in Series C investment in July 2024. 

Founded in 2015, the app now has over 75 million active users, according to the company’s LinkedIn page, allowing people to track period and ovulation cycles, monitor symptoms and access personalised health insights and educational content on topics such as pregnancy and perimenopause. 

Claimants say that Flo integrated tracking tools, including Meta’s software development kits, which automatically transmitted sensitive personal data as users engaged with the app, according to reports from Law360.

They are seeking $1,000 in statutory damages under California’s medical privacy law for 13 million Flo users who downloaded and registered on the app between late 2016 and early 2019, meaning the company could face up to $13bn in potential damages.

Claims brought against Google for the same as part of the same case were settled earlier in July 2025 for an undisclosed sum.

In a statement to Femtech World, a spokesperson for Flo said: “Flo is committed to protecting the privacy of its users, and any allegation otherwise has no merit. We are building a better future for women, and are steadfast in our commitment to protecting your privacy and data.”

Calls for stricter regulation in femtech 

In 2021, users of the app filed a lawsuit against Flo, Google and Meta following a settlement between Flo and the Federal Trade Commission after allegations that the company shared health information with third-party advertising companies without permission.

Flo denies these claims and says it agreed to settle the matter to “avoid the time and cost associated with litigation”.

A report from Cambridge’s Minderoo Centre for Technology and Democracy, published last month, called for stricter regulation and governance of femtech apps, highlighting how menstrual cycle tracking tools are a “gold mine” for consumer profiling.

In the report, lead author Dr Stefanie Felsberger argues that the financial worth of this data is “vastly underestimated” by users who supply profit-driven companies with highly intimate details in a market lacking in regulation, leaving them at risk of data and privacy breaches. 

However, in a LinkedIn post from 12 June, Sue Khan, vice president of privacy and data protection officer at Flo, responded to the report stating: “We have never – and will never – monetise or sell user data. We do not see personal data as a commodity, and categorically reject the notion that women’s health data should be treated as a goldmine for advertising.”

Potential impacts for the wider sector 

Stephanie Caird, life sciences partner at UK law firm Mills & Reeve, told Femtech World that while data and privacy laws differ significantly between jurisdictions, the case against Flo may well lead to calls for stricter regulation of femtech apps, with potentially wide-reaching implications for the whole sector. 

“We suspect that the case might fuel calls for stronger regulation of cycle tracking and other femtech apps,” Caird says.

“We would note that the data privacy regime in the US differs from the UK and Europe, particularly as different states have slightly different rules on personal data, and there is an overarching federal law relating to protected health information [Health Insurance Portability and Accountability Act].

“Even so, if there is a decision that the sharing of data by Flo was improper, the effects could be felt here in the UK, as user trust and confidence in the security of their personal data and how this is being used may be undermined. This could lead to nervousness from users impacting the wider femtech sector, which could further reduce engagement with and investment in an already underfunded eco-system.”

Caird adds: “It is worth noting that there are already a variety of frameworks in place in the UK which, when taken together, should be providing a sufficiently robust framework to protect users’ data.”

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Premature menopause is a high blood pressure risk, study finds

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Premature menopause is linked to a higher risk of developing high blood pressure, according to a study of more than 107,000 women.

The risk was highest among women who reached menopause between the ages of 25 and 35.

Researchers said the findings support earlier cardiovascular screening for women who reach menopause before the age of 40.

Dr Stephanie Faubion, medical director for The Menopause Society, said: “The results of this study highlight the potential adverse long-term health outcomes associated with premature menopause, and in particular, the need to regularly screen for cardiovascular risk factors such as hypertension.

“Use of hormone therapy is also routinely recommended in women with premature menopause at least until the natural age of menopause unless contraindications exist.”

Hormonal changes during menopause are known to affect women’s wider health, while earlier menopause has previously been linked to coronary heart disease and stroke.

Coronary heart disease develops when the blood vessels supplying the heart become narrowed or blocked.

However, previous evidence directly linking the timing of menopause to high blood pressure has been mixed.

High blood pressure, also known as hypertension, puts extra strain on the heart and blood vessels and can increase the risk of heart disease and stroke.

Researchers said it can be difficult to separate the direct effects of hormonal changes from factors that often accompany menopause, including weight gain, metabolic changes and other cardiovascular risks.

Metabolic changes affect how the body processes and uses energy, including sugar and fat.

The study analysed data from 107,836 postmenopausal women who joined the UK Biobank between 2006 and 2010. They were followed for a median of almost 15 years.

Researchers divided the women into three groups based on their age at menopause: after 45, between 40 and 45, or before 40.

They also examined whether menopause occurred naturally or followed surgery.

During the follow-up period, 18,508 women, or 17.2 per cent, were diagnosed with high blood pressure.

The proportion increased as the age at menopause fell. Hypertension developed in 16.6 per cent of women who experienced menopause after 45, compared with 18.8 per cent of those who reached menopause between 40 and 45.

Among women who experienced menopause before 40, 22.6 per cent developed the condition.

After taking account of more than 50 factors, including weight, lifestyle habits, family history and laboratory results, premature menopause remained linked to a 12.3 per cent higher risk of hypertension than menopause after age 45.

Further analysis suggested the risk peaked among women who reached menopause between the ages of 25 and 35.

The researchers said this may mean that the cardiovascular risk associated with premature menopause is concentrated among a younger group than the conventional under-40 definition suggests.

Surgical menopause was initially linked to higher rates of hypertension, but the association was no longer significant after other risk factors were taken into account.

The authors said clinicians should consider age at menopause as a distinct cardiovascular risk factor, particularly for women who experience it before 40.

They also called for earlier detection and management of hypertension, alongside individual discussions about hormone therapy.

Hormone therapy replaces hormones that decline during menopause and may be recommended for some women, depending on their individual health and medical history.

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Natural Cycles receives sixth FDA clearance for fertility algorithm

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Natural Cycles has received its sixth FDA clearance for an updated fertility algorithm designed to personalise digital contraception.

The regulator cleared the company’s next-generation NC° Fertility Algorithm, which combines statistical modelling with machine learning to predict fertile and non-fertile days.

Natural Cycles said the algorithm was trained on tens of millions of real-world fertility data points and adapts to individual cycle patterns.

“People don’t just want effective birth control; they want a method that fits naturally into their lives,” said Dr Elina Berglund Scherwitzl, chief executive and co-founder of Natural Cycles.

“One of the unique advantages of a software-based contraceptive is that it can continue to evolve.

“As our scientific understanding of fertility grows and we continue to learn from more than a decade of real-world data, we can responsibly refine the technology through rigorous research, clinical validation, and FDA review.

“This latest clearance is the result of that work, helping us give many users more flexibility while maintaining the effectiveness they rely on.”

Evidence supporting the FDA clearance showed that the updated system maintained the app’s established safety and effectiveness while giving many users more Green Days.

Green Days are those on which the app confirms that pregnancy protection is not needed.

The birth control app remains 98 per cent effective when used as intended and 93 per cent effective with typical use, according to the company.

Natural Cycles said these rates place it in the same effectiveness category as the combined oral contraceptive pill.

Typical use includes mistakes or inconsistent use, while intended use means following the method correctly.

Digital contraception uses technology and physiological data, such as body temperature, to provide personalised fertility predictions.

Natural Cycles said its updated algorithm can identify fertile and non-fertile days more precisely than traditional fertility awareness methods, which may classify larger parts of the cycle as potentially fertile.

The changes provide more Green Days while maintaining effectiveness, improve performance for people with irregular cycles and better handle lower-quality temperature or biomarker data, the company said.

A biomarker is a measurable biological signal, such as body temperature, that provides information about processes taking place in the body.

Natural Cycles also said the system can personalise its predictions more quickly as a user’s menstrual cycle changes over time.

“Years ago, the question was whether digital contraception could work. Today, Natural Cycles has demonstrated robust clinical and real-world evidence that it can,” said Dr Kerry Krauss, senior medical adviser at Natural Cycles.

“The next chapter for digital contraception is making it more personalised and easier to use while maintaining the same high standard of safety.

“This FDA clearance demonstrates how advances in AI and machine learning can improve the user experience while preserving the scientific rigour expected of a regulated medical device.”

Natural Cycles has filed a patent application covering key innovations in the updated algorithm.

The decision follows the FDA’s first De Novo clearance of the company’s birth control app in 2018.

Later clearances allowed the app to integrate with the Oura Ring in 2021 and Apple Watch in 2023.

In 2024, the FDA cleared a Predetermined Change Control Plan, creating a regulatory pathway for future hardware integrations.

Natural Cycles said the plan has since enabled the launch of its NC° Band and other hardware integrations, including a Garmin connection introduced in March 2026.

A further clearance in 2025 allowed the birth control app to be offered both over the counter and by prescription.

The company has also received regulatory authorisations in more than eight markets worldwide, including Europe, Canada, Brazil, Australia, South Korea and Singapore.

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Experimental treatment significantly slows progression of fatal brain disease in women, study finds

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Davunetide may significantly slow the progression of a fatal brain disease in women, according to a new analysis of clinical trial data.

The findings indicate that women and men with progressive supranuclear palsy (PSP) may respond differently to the experimental treatment.

Progressive supranuclear palsy, or PSP, is a rare and fatal neurodegenerative disease.

Researchers at Tel Aviv University led the analysis and said the results reinforce the need for sex-specific approaches to neurodegenerative diseases.

Neurodegenerative diseases are conditions in which nerve cells in the brain or nervous system gradually lose function and die.

The team reanalysed data from a 52-week international clinical trial involving more than 300 people with PSP.

The disease is caused by the abnormal accumulation of tau protein in the brain. Tau is a protein found in nerve cells that builds up abnormally in people with PSP.

There is currently no effective drug treatment for the disease.

The work was led by professor Illana Gozes of the Sagol School of Neuroscience and the Gray Faculty of Medical and Health Sciences at Tel Aviv University.

The research team included current and former students Dr Guy Shapira, Jason Blatt and Liri Guz, together with professor Noam Shomron.

The original clinical trial found that Davunetide was safe but ineffective.

However, the researchers separated female and male participants and re-examined the data using updated assessment measures recommended by the FDA.

Women treated with Davunetide experienced a significant slowing of disease progression, while no similar effect was observed in men.

The treatment helped preserve essential movement and functional abilities, including balance, fine motor skills and everyday tasks such as using cutlery, buttoning clothes and washing the face and hands.

Fine motor skills are the small, precise movements needed for tasks involving the fingers and hands.

Treated women also showed significant improvements in language ability, working memory and overall cognitive function.

Cognitive function covers mental abilities such as memory, attention, language and problem-solving.

The analysis also identified profound molecular differences between women and men.

The relationship between levels of pathological tau in cerebrospinal fluid and clinical symptoms was completely reversed between the sexes.

Cerebrospinal fluid is the clear liquid surrounding the brain and spinal cord. A biomarker is a measurable sign that can indicate disease activity.

For example, language abilities declined significantly as tau pathology increased in women, but not in men.

The researchers said this suggests the disease mechanisms may work differently in women and men, potentially explaining their different responses to treatment.

According to professor Gozes, overlooking biological differences between the sexes may hide a genuine treatment effect.

“Our data show that analysing women and men separately is not merely a statistical exercise, but an essential tool for developing more effective treatments for neurodegenerative brain diseases,” she said.

The researchers believe the findings provide a strong scientific basis for future clinical trials and treatment protocols designed from the outset to account for patients’ sex.

These trials could evaluate Davunetide as a targeted treatment for women with PSP.

They said the approach may also pave the way for more precise treatments for tau-related diseases, including Alzheimer’s disease and other neurodegenerative brain disorders.

The study was supported by ExoNavis Therapeutics, which is developing Davunetide for brain diseases under licence from Ramot, Tel Aviv University’s technology transfer company.

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