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Round up: FDA clearance for AI-powered embryo assessment tool

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Femtech World explores the latest developments in the world of technology and women’s health.

30-minute non-invasive test to revolutionise endometriosis detection

A new diagnostic tool for endometriosis will now be available in Canada.

EndoDiagnosis will be the sole distributor in Canada for the ENDOSURE Tier 1 diagnostic test for the condition, which cuts down the average diagnosis time from over eight years to just 30 minutes.

In the past, diagnosing endometriosis required invasive laparoscopic surgery. This often meant that patients endured years of pain and a lower quality of life without a proper diagnosis.

The ENDOSURE test offers a non-invasive option, boasting 99 per cent accuracy in detecting all stages of the disease in less than an hour. This bypasses the need for surgical procedures.

The ENDOSURE Tier 1 test is designed for women of any age and provides results on the spot without the need for referrals or lab work.

Its non-invasive nature not only spares patients from unnecessary surgical procedures but also enables healthcare professionals to concentrate on therapeutic strategies to manage the disease, preserving both quality of life and fertility.

EndoDiagnosis offers training and certification for healthcare providers, professional medical education, and awareness programmes, along with a provider directory to help patients find testing centres.

AutoIVF awarded NIH SBIR grant to advance OvaReady

Fertility technology company AutoIVF has been awarded a Phase IIB Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH).

The award is supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development.

The NIH grant will support commercialisation of AutoIVF’s flagship platform, OvaReady, an automated desktop system intended to streamline the egg identification and preparation process for in vitro fertilization (IVF).

The platform is being developed to support the decentralization of egg retrieval, with the goal of expanding access to fertility care beyond traditional IVF lab settings.

The device is currently in development

“The NIH’s sustained support over the past five years – from early feasibility to commercialization- reinforces the scientific merit and clinical potential of our approach,” said Emre Ozkumur, vice president of R&D at AutoIVF.

“We’re proud to be driving innovations intended to improve care for patients undergoing infertility treatment or fertility preservation.”

“Being selected through the NIH’s highly competitive review process shows the real potential the technology has to improve outcomes for patients, doctors, and the broader fertility field,” said co-founders Drs. Thomas Toth, Michael Alper, and Alan Penzias.

“With decades of experience as IVF physicians, we see OvaReady as a game changer – making it easier and more efficient to identify and prepare eggs for IVF and fertility preservation.”

FDA clearance for AI-powered embryo assessment tool

Reproductive care company Fairtility has confirmed that its CHLOE platform has achieved U.S. Food and Drug Administration (FDA) 510(k) clearance for one of its AI-powered embryo assessment tools, CHLOE Blast.

The clearance makes it the first and only FDA-cleared machine learning AI-powered clinical decision support software for embryo assessment.

The embryo assessment function of CHLOE analyses time-lapse embryo images to enable more objective and consistent evaluations.

Using clinical evidence, the CHLOE suite is designed to enhance the standard of care by improving workflow efficiency and bringing transparency to the IVF patient’s journey.

CHLOE supports embryologists with consistent embryo and oocyte assessments, helps doctors communicate more clearly with patients, provides management with data-driven visibility and empowers patients with greater transparency and engagement.

“This FDA clearance is more than a regulatory milestone,” said Moti Shniberg, founder of Nacre Capital, an investor in Fairtility.

“It reflects Fairtility’s leadership in bringing AI into reproductive medicine and marks the beginning of a new era of standardization, transparency, and improved outcomes for patients and clinics alike.”

PCOS fertility programme to offer tech-enabled coaching

Bellwether Wellness and Zone Labs have announced the launch of PCOSynergy, the first fertility programme for women with Polycystic Ovary Syndrome (PCOS) to unite biomarker technology with the proven science of metabolic engineering.

PCOSynergy shifts the focus from waiting for answers to taking proactive steps women can control today: improving metabolic health, reducing inflammation, and building confidence through structured coaching and tech-enabled tracking.

The programme features weekly video learning and tech-enabled biomarker tracking, group coaching and community support, and personalised one-on-one onboarding and data-informed monthly guidance.

This feature underscores that PCOSynergy provides ongoing individualised coaching, not just initial onboarding.

The platform also introduces a first-of-its-kind coaching-based promise: If participants in the extended programme do not achieve pregnancy, their tuition fees will be refunded.

“This is a game-changing moment for women with PCOS,” explains Christine Updegraff, CEO of Bellwether Wellness.

Together with Zone Labs, we’re delivering the tools, nutritional science, and compassionate support women need to move forward with clarity and confidence.

Approval for companion diagnostic test to identify HER2-ultralow breast cancer

Roche has received CE IVDR approval for two label expansions for its VENTANA HER2 Rabbit Monoclonal Primary Antibody RxDx* assay.

HER2 is a receptor protein expressed in a variety of cancers and serves as a predictive biomarker to help determine if a patient will respond to HER2-targeted therapy.

The VENTANA HER2 test is the first and only companion diagnostic approved to identify patients with HR-positive metastatic breast cancer that are HER2-ultralow.

These patients may be eligible for treatment with ENHERTU (trastuzumab deruxtecan), a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.

In addition, this test is now the first and only companion diagnostic to aid in the assessment of HER2-positive status to identify biliary tract cancer patients with an immunohistochemistry score of 3+ who are eligible for treatment with Jazz Pharmaceuticals’ ZIIHERA.

The VENTANA HER2 test was used in the DESTINY-Breast06 trial, which demonstrated a significant improvement in progression-free survival with ENHERTU compared to standard of care chemotherapy in patients with HER2-low and HER2-ultralow metastatic breast cancer.

The assay delivers timely, clear and reliable results, driving diagnostic certainty and enabling therapeutic decisions that can lead to better outcomes for patients.

The test is used in combination with the fully automated VENTANA BenchMark slide staining instrument.

Mental health

Pilates may improve heart and metabolic health in sedentary women, study finds

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A four-week Pilates programme may improve heart, metabolic and stress measures in previously sedentary women, a small study suggests.

Pilates is a mind-body form of exercise that has been linked to better fitness, balance, posture, muscular endurance, mental wellbeing and quality of life in different groups.

Built around breathing, concentration, control, precision, centring and flow, Pilates is already used in physiotherapy, rehabilitation and preventive health. The new study looked at whether a structured four-week programme could affect cardiovascular, metabolic, body and stress-related measures in sedentary adult women.

The longitudinal study included 30 sedentary women split into two age groups, 30 to 40 and 50 to 60.

All participants completed a standardised, supervised Pilates programme lasting four weeks, with three sessions a week lasting 50 to 60 minutes.

Researchers measured resting heart rate, systolic and diastolic blood pressure, body mass index, abdominal circumference, fasting blood glucose and serum cortisol at the start and end of the programme.

Systolic and diastolic blood pressure are the top and bottom readings in a blood pressure test. Cortisol is a hormone linked to the body’s stress response.

The four-week Pilates programme was linked to improvements in cardiovascular, metabolic, body and neuroendocrine measures, although not every change reached statistical significance within each age group.

In the younger group, significant reductions were seen in heart rate, blood pressure, body mass index and fasting blood glucose after the intervention.

The reduction in blood pressure after the programme was significantly greater in the older group than in the younger group.

Older participants also showed a greater reduction in glucose and cortisol levels after the intervention than younger participants.

Analysis also found significant links between cardiovascular, metabolic and neuroendocrine changes.

In the younger group, this was particularly seen between heart rate and blood pressure responses.

In the older group, it was particularly seen between changes in body mass index and fasting glucose.

The findings suggest Pilates could be a useful multidimensional exercise approach for cardiometabolic health and stress regulation in previously sedentary women.

The researchers said the larger reduction in blood pressure seen in the older group may reflect a higher cardiometabolic burden at the start, leaving more room for improvement after the programme.

The greater reduction in fasting glucose and cortisol in older participants may similarly suggest that people with higher baseline metabolic and neuroendocrine dysfunction could benefit more from structured exercise such as Pilates.

Although Pilates is known to improve body composition through energy use, neuromuscular activation and support for healthier habits, the researchers said the fall in body mass index over four weeks is unlikely to be explained by Pilates alone.

They noted that participants were also told to avoid alcohol, sugar-containing products and sugar-sweetened drinks during the intervention, which may have contributed to the change.

In the younger group, the link between heart rate and blood pressure suggested coordinated cardiovascular responses after Pilates.

The researchers also found that cortisol appeared to be linked to blood pressure and body mass index, suggesting stress-related changes may be tied to cardiovascular and body regulation after the intervention.

In the older group, the link between body mass index and fasting glucose highlighted the relationship between body fat and metabolic regulation.

A positive link between blood pressure and body mass index in this group also suggested that improvements in vascular regulation may be associated with reductions in body mass.

Overall, the findings suggest Pilates-related physiological changes may involve interconnected cardiovascular, body, metabolic and neuroendocrine mechanisms, with different response patterns by age.

The study has important limits. It did not include a non-exercise control group, so it cannot prove Pilates directly caused the changes.

The sample size was also small, which limits how far the findings can be applied more widely.

The authors also noted that cortisol was measured using a single fasting morning sample, which limits conclusions about broader hypothalamic-pituitary-adrenal axis regulation, the system involved in the body’s stress response.

They said larger studies with longer follow-up will be needed to confirm whether Pilates causes these physiological changes over time.

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Diagnosis

Being female not a universal stroke risk factor for patients with AF, study finds

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Female sex may not raise stroke risk across all atrial fibrillation (AF) patients, with higher risk mainly seen in women aged 75 and older, a study suggests.

Researchers said stroke prevention for women with the condition should be more personalised, especially for patients under 75.

Dr Amitabh C Pandey, director of cardiovascular translational research at Tulane University School of Medicine, said: “For years, female sex has been included as a risk factor along with other factors such as high blood pressure and diabetes, meaning women were more likely to be prescribed anticoagulants.

“Our study shows younger women may not have as much added stroke risk as previously thought, while older women, particularly those over 75, appear to have a higher risk that deserves close attention.”

The new Tulane University study challenges a long-standing assumption in heart care that being female automatically increases stroke risk for patients with atrial fibrillation.

Atrial fibrillation, often called AF, is a common heart rhythm disorder that causes the heart to beat irregularly.

It is associated with a higher risk of stroke and is often treated with anticoagulants, also known as blood thinners.

The study found that stroke risk did not increase equally across all female patients with AF.

Instead, researchers said being female may act more as a risk modifier, with increased stroke risk seen primarily among women aged 75 and older or those with a greater burden of other health conditions.

Clinicians often use a scoring system to decide whether people with AF should be prescribed blood thinners.

The system gives points for factors including age, heart failure, diabetes, previous stroke, vascular disease and high blood pressure.

Women also receive one point for sex alone.

Researchers said this can mean women with AF become eligible for blood thinners earlier or more often than men with otherwise similar risk profiles.

While blood thinners can help prevent clot-related strokes, they can also increase the risk of bruising, prolonged bleeding, gastrointestinal bleeding and other serious complications.

The researchers analysed approximately 950,000 patients with AF using TriNetX, a large anonymised electronic health record database.

They compared stroke outcomes between male and female patients across three age groups: younger than 65, 65 to 74, and 75 and older.

Male and female patients were matched based on age, other health problems and whether they had been prescribed anticoagulation medicine.

Among patients younger than 75, the study found no significant difference in one-year stroke risk between men and women.

However, among patients aged 75 and older, women had a modest but statistically significant increase in stroke risk compared with men.

In patients aged 75 and older with no additional risk factors beyond age, women had about one additional stroke per 629 patients compared with their male counterparts.

The findings support growing interest in a newer AF risk score, known as CHA2DS2-VA, which removes sex as a standalone risk factor.

However, researchers said more studies are needed and medical guidance remains inconsistent.

Han Feng, assistant professor at Tulane University School of Medicine, said: “This general approach came from women being underrepresented in AFib trials and studies comprising only about one-third of study populations.

“Our study shows not all women with AFib have the same risk profile, and these decisions should be individualised.

Pandey said: “These findings highlight the need for modern tools and approaches that can personalise risk profiles to individuals.

“The goal is not to undertreat patients who need stroke prevention, but to better identify who is most likely to benefit from anticoagulation and who may be exposed to unnecessary risk.”

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Hormonal health

Iron deficiency in women: The tiredness everyone normalises

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Article produced in association with Spital Clinic

Feeling permanently tired has become so normal for so many women that most of us have stopped questioning it. But one of the most common reasons behind it is also one of the easiest to miss – and one of the most satisfying to fix.

The tiredness that gets explained away

There’s a particular kind of tired that a lot of women simply live with. The mid-afternoon slump that no amount of coffee touches. Needing an early night and still waking up flat. Putting it all down to work, kids, stress, age or hormones – anything except a cause you could actually do something about.

Often, though, that’s exactly what it is: a cause you could do something about. Low iron is one of the most common reasons women feel wiped out, and because it builds so gradually, it rarely announces itself. You don’t wake up one morning feeling different. You just slowly get used to running on less, until “exhausted” starts to feel like your baseline.

Why women are far more likely to run low

Iron is what your body uses to carry oxygen around in your blood. When levels fall, everything has to work a little harder to do the same job – which is why feeling tired is usually the very first thing you notice.

The reason this affects women so disproportionately is simple: periods. Every cycle carries a small iron cost, and over months and years that quietly adds up. Pregnancy adds to the demand too, when the body’s iron needs rise sharply.

But heavy periods are the big one – left unchecked, they can steadily drain your iron, which is why the NHS treats them as something worth looking into rather than just putting up with.

So if your periods sit on the heavier side, you’re not just dealing with the inconvenience in the moment – you may be slowly draining your iron stores at the same time, month after month.

The reassuring part is that heavy periods can be treated, so it’s worth having them looked at rather than soldiering on.

What low iron actually feels like

Tiredness is the headline, but it’s rarely the only clue. Low iron can show up as feeling breathless going up stairs you used to manage without thinking, a foggy, can’t-quite-focus feeling, looking paler than usual, or noticing your heart racing or thumping for no obvious reason.

Then there are the stranger signs people almost never connect to iron: brittle nails, more hair than usual collecting in the brush, restless legs at night, and – oddly – craving and crunching ice. On their own, each of these is easy to shrug off. Lined up together, they’re very often the same story.

Why it so often slips under the radar

Part of the problem is that none of these symptoms screams “iron.” They’re vague, they overlap with ordinary life, and they arrive slowly enough that you adjust without realising. Most of us are also remarkably good at minimising our own tiredness – we assume everyone feels like this, so there’s nothing to mention.

The result is that low iron can go unaddressed for years, not because it’s hard to find, but because nobody thinks to look. It’s a genuinely common, genuinely treatable issue that quietly chips away at how good you’re allowed to feel.

When “heavy” periods are actually heavy

Here’s the tricky bit: most women have no real benchmark for what counts as heavy, because the only period we ever experience is our own. A useful rule of thumb is needing to change a pad or tampon every hour or two, bleeding that lasts longer than seven days, or passing clots bigger than a 10p coin.

NICE frames it even more usefully: periods count as heavy if they’re getting in the way of your life – physically, emotionally or socially. You don’t have to measure anything. If you’re planning your week around your period, doubling up on protection, or it’s leaving you drained, that’s reason enough to take it seriously.

And the good part is they don’t have to be permanent. If yours have crept up over time, getting them under control is worth it in its own right – and it often tackles the iron problem at its source, rather than topping you up only to lose it again next month.

How you actually find out

You can’t tell your iron levels from how you feel. Plenty of women feel rough with results that look “borderline fine,” and some feel reasonably okay while their reserves are already running low.

The only way to know is a straightforward blood test that checks both your blood count and your ferritin – the marker that reflects how much iron you’ve actually got stored away.

Ferritin is the one that matters here, because it tends to drop first, before a standard anaemia test would flag anything as wrong. That’s exactly why a woman can be told her bloods are “normal” and still feel exhausted: the headline number looks acceptable, but the reserves sitting behind it have been running down for a while.

The good news: it’s very fixable

This is the part worth holding onto. Iron deficiency is one of the more rewarding things to put right. The NHS approach is usually a course of iron tablets over several months to rebuild your stores, paired with a source of vitamin C – even just a glass of orange juice – to help your body absorb them properly.

Alongside that, dealing with whatever’s causing the loss in the first place is what stops you ending up back at square one.

Most women start to notice the difference within a few weeks, often well before their levels are fully restored. The fog lifts, the stairs get easier, and the version of “normal” you’d quietly resigned yourself to turns out not to have been normal at all.

The takeaway

The exhaustion so many women treat as a fixed fact of life frequently isn’t one. Low iron is common, it’s quick to check, and it’s straightforward to put right – but only if someone actually looks for it.

If you’ve been tired for longer than you can remember, especially if your periods are heavy, it’s worth getting your iron checked rather than explaining it away for another year. Speaking to a GP is usually all it takes to get that started – and more often than not, the fix turns out to be far simpler than the months of tiredness would suggest.

Disclaimer: This article is produced for informational purposes only and does not constitute medical advice, diagnosis or treatment. Clinical guidance referenced reflects published NHS and NICE information as at May 2026. Individual circumstances vary; readers are advised to consult a qualified healthcare professional before acting on any information in this article. This piece was produced in association with Spital Clinic, which provided background clinical information for editorial purposes. Hyperlinks to external sources are included for reference only and do not represent an endorsement of any product, service or organisation.

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