Hormonal health
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.
Manchester City has launched a female athlete health platform covering menstrual, pelvic and breast health, as well as nutrition.
The Her City website is designed for the club’s women’s first-team players, coaches, support staff, academy players and parents.
Manchester City says the platform is the first of its kind in the Women’s Super League and was developed over two years.
The project was led by director of performance services Emma Deakin, physical performance scientist Rosie Anderson and PhD student and first-team nutritionist Sarah Malone.
It grew out of PhD research into menstrual, pelvic and breast health and nutrition, with the team seeking to turn that work into an online educational resource.
The website divides the four areas into separate sections and provides peer-reviewed information that the club says has been critically analysed by experts.
Content will continue to be reviewed and updated as further evidence emerges.
Resources include posters, visual explainers, audio materials and downloadable educational content, with information tailored to different groups including players and parents.
The platform aims to improve knowledge, develop critical analysis skills and strengthen communication within football and at home.
It also includes material to help users assess misinformation they encounter on social media or elsewhere.
A confidential contact form allows users to raise concerns or ask questions directly of experts at Manchester City.
Parents of academy players can also access the platform, with resources intended to help them support their children during a key phase of their development.
Manchester City said its longer-term aim is to make the platform available to all women working across City Football Group.
Michigan State University researchers are launching a novel project to transform how medications are developed and prescribed for women.
A US$4.6m award will fund computer models designed to predict how hormonal changes affect the way medicines move through and act in women’s bodies.
The funding is the first instalment of an award worth up to US$12.8m over three years, supporting work intended to account for hormonal changes throughout women’s lives.
Researchers plan to examine factors including menstrual cycles, pregnancy, contraceptive use, menopause and hormone replacement therapy, which can affect responses to medicines.
Teresa K. Woodruff, lead investigator on the project, said: “Because female hormone levels are constantly shifting, precision medicine allows us to map out these complex interactions.
“This NIH-backed initiative will create the first computationally driven clinical tool designed to guide medical care across every stage of a woman’s life.”
The project is led by researchers at Michigan State University and funded by the National Institutes of Health, with collaborators from Rutgers, Emory, Tulane, the University of Colorado Anschutz, the University of Michigan and the University of Utah.
Thirteen researchers will develop computational models to predict how changes in female hormones influence the way medicines move through and act within the body.
The work is part of the NIH Computational Modeling of Hormone Homeostasis Initiative, which is awarding US$21m nationally to support research into sex-specific hormonal biology.
The team plans to use artificial intelligence to digitise and organise more than 40 years of hormone research data in a publicly accessible database.
Researchers will also develop a standard computer model of a 28-day menstrual cycle, alongside models of how hormones regulate organs and tissues involved in processing nutrients, including the liver, muscle and fat.
Real-world patient data will then be used to expand the models to represent groups including women going through menopause or taking birth control, as well as women with conditions such as diabetes and obesity.
The project will also use three-dimensional human tissue models and lab-grown organoids, including liver, muscle and ovarian tissue, to test and refine the computer predictions.
Researchers plan to examine medicines including metformin, insulin and GLP-1 drugs, with the aim of developing tools that could help clinicians tailor doses and avoid harmful side effects.
Qiang Zhang, associate professor at Emory University, said: “Empowered by AI, novel assays and legacy human data, we will develop mechanistically based computational models of female physiology that can make translational, quantitative predictions for women’s responses to metabolic therapies.”
The researchers said the work could help address differences in how women respond to treatments for metabolic conditions including obesity, type 2 diabetes, cholesterol imbalances and thyroid disorders.
Nanette Santoro, professor at the University of Colorado Anschutz and president of the Endocrine Society, said: “Women experience large shifts in reproductive hormones at several points in their lifespan: puberty, pregnancy and menopause.
“During reproductive years, women also undergo profound day-to-day changes in reproductive hormone levels, giving them a markedly different endocrine backdrop than men.
“Using state-of-the-art computational technology to examine how these changes interact with commonly used medications is a critical pathway toward supporting life-course women’s health.”
The project team said its computer models and data will be made freely available to researchers and healthcare professionals when the work is completed.
Gail’s has unveiled a menopause action plan offering new workplace support to thousands of staff ahead of legal reforms due in 2027.
The high street bakery chain will offer new benefits including 24/7 digital GP access and a new employee assistance programme, according to The Times.
It will also explore new online training for staff, including specific training for management.
Gail’s people director Miranda Burgum told The Times: “All we’re trying to do is talk freely and for it not to be a forbidden subject. It’s helping our managers and teams understand that this isn’t a taboo.”
“We’re going to develop the education with our managers, so it will be threaded through all our policies
“It will look at induction training, it will look at the types of people we need to make sure that we make reasonable adjustments for.
“And if somebody needs some sort of risk assessment, we’re going to be looking at [that].”
The move comes ahead of reforms due to be introduced in spring 2027 under the Employment Rights Act.
UK employers with 250 or more employees will be legally required to publish and update official menopause action plans.
The plans are intended to support employers to take effective action to improve workplace gender equality and support employees experiencing menopause.
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