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

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.
Motherhood
Expectations about sleep affect postpartum sleep quality, study finds

Pregnant women’s expectations about postpartum sleep may predict sleep quality after birth, outweighing prior sleep and psychiatric history, a study suggests.
The findings suggest attitudes and beliefs about sleep during pregnancy could be a modifiable risk factor for postpartum sleep concerns.
They also indicate that, among women expecting the poorest sleep, higher postpartum anxiety may further worsen sleep quality.
Sammy Dhaliwal, lead author is clinical health psychologist and research fellow in the department of obstetrics and gynaecology at the Perelman School of Medicine at the University of Pennsylvania.
Dhaliwal said: “Most pregnant women in our sample anticipated poor postpartum sleep before it occurred, and it was striking that those expectations predicted worse sleep outcomes even after accounting for factors such as prior sleep disorders, psychiatric history, and number of previous births.
“This suggests that attitudes and beliefs about sleep during pregnancy may represent a modifiable target for early intervention before postpartum sleep problems emerge.”
Sleep disturbance affects an estimated 60 to 80 per cent of postpartum women and is linked to a higher risk of depression and anxiety.
Researchers said it is often regarded as an expected part of life after childbirth rather than a health issue that may be addressed earlier.
The study enrolled 432 pregnant women at about 24 weeks of gestation, meaning around 24 weeks into pregnancy.
Participants completed measures of their expectations about postpartum sleep, current sleep quality using the Pittsburgh Sleep Quality Index, and mood using validated depression and anxiety scales.
Assessments were repeated at six, 12 and 24 weeks postpartum.
A subset of 49 women also wore wrist actigraphy devices at six to eight weeks postpartum.
Actigraphy uses a wearable device, similar to a watch, to estimate sleep and wake patterns based on movement.
The results showed that 70 per cent of pregnant women, or 301 of 432 participants, expected poor sleep in the postpartum period.
Researchers found that predicted sleep disruption during pregnancy was a significant predictor of postpartum sleep concerns.
Among first-time pregnant women without prior health concerns, those who expected greater sleep disturbance had significantly more disrupted sleep after birth, measured by both actigraphy and self-report.
Among women who expected the worst sleep quality, higher postpartum anxiety significantly worsened both measured sleep and self-reported sleep, independent of anxiety levels during pregnancy.
Dhaliwal said the findings point to two possible areas for intervention: addressing sleep-related beliefs during pregnancy and treating postpartum anxiety.
Dhaliwal said: “Postpartum sleep disruption is often treated only after problems develop, but our findings suggest there may be an opportunity to intervene earlier during pregnancy.
“Addressing sleep-related beliefs and postpartum anxiety during prenatal and postpartum care may help improve sleep and emotional well-being in new mothers.”
Mental health
Pilates may improve heart and metabolic health in sedentary women, study finds

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

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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