Fertility in Focus
At-home cervical cancer screening device demonstrates comparable performance to clinic-based testing in major US trial
A self-collection device for cervical cancer screening has shown equivalent effectiveness to traditional clinic-based testing, according to new research that could help address screening gaps affecting women’s health outcomes.
The SELF-CERV trial, which validated the Teal Wand device across 16 medical sites in the United States, found that self-collected samples detected precancer 96 per cent of the time with comparable performance to clinician-collected samples.
The study was led by researchers at the University of Colorado School of Medicine.
Christine Conageski is associate professor of obstetrics and gynaecology and principal investigator for the trial.
Conageski said: “Studies have shown that half of new diagnoses of cervical cancer are those that were not screened in the preceding five years.
“That tells us that cervical cancer has really become a disease of access: access to the vaccine for prevention, access to cervical cancer screening, and follow up management of the first abnormal screen.”
The US Food and Drug Administration approved the Teal Wand in early May following completion of the trial, which involved more than 600 participants who received mailed kits with instructions for easy sample collection and return to laboratories.
Researchers estimate that a quarter of women are not up to date on their cervical cancer screening, commonly known as a pap smear.
Current US guidelines recommend screening every three years for women aged 21 to 29 years and every five years for women aged 30 to 65 years.
Conageski, who is also a physician at the CU Cancer Center, said: “We’ve not seen the number of cervical cancer cases in the US budge in the better part of five years, and it’s because screenings are not reaching those who are at greatest risk.”
The trial revealed significant barriers to clinic-based testing, with 32 per cent of participants reporting delays due to time constraints, 32 per cent citing discomfort with examinations, and 32 per cent noting financial issues as reasons for delay.
The at-home device appeared to address many of these concerns, with 86 per cent of participants saying they would be more likely to stay up to date with screening if they could complete it at home. Over 90 per cent said they preferred the self-collection method.
Conageski said: “With the Teal Wand, it took 90 per cent of patients less than five minutes to complete the sample collection and 60 per cent of patients less than two minutes, so it’s a quick and easy process.
“You can fit this into your schedule, whenever that may be, and avoid having to schedule an appointment,”
Cervical cancer is typically linked to certain types of human papillomavirus (HPV), which is transmitted through sexual contact.
“While many people are infected with HPV, only a small percentage develop cervical cancer, making early screening crucial for detection and intervention.
Conageski said: “If we can make screening more accessible to those that we’re not currently reaching, that is ultimately going to drive cervical cancer rates down, because cervical cancer is an almost 100 per cent preventable cancer,”
The researchers suggest that widespread implementation could benefit both patients and healthcare systems, allowing physicians to focus on other aspects of patient care during visits whilst maintaining confidence in screening reliability.
Femtech World explores the latest business developments in the world of women’s health.
NHS platform Evaro partners with period tracking app Clue in UK-first integration
Evaro, the NHS-licensed embedded healthcare platform, has announced a first-of-its-kind partnership with the period tracking app Clue.
The partnership will provide seamless access to NHS-funded contraception directly through Clue’s app.
This marks the first time a major cycle-tracking platform has integrated prescription healthcare services in the UK, creating a critical solution as the country grapples with an emergency contraception crisis.
2023 data shows the UK had the highest global search volume for emergency contraception and nearly half of UK women face contraception access barriers, with one in 20 patients having to wait at least four weeks to see a GP.
The partnership launches as women’s health takes center stage in the government’s NHS modernisation agenda, with digital medicine transformation identified as a key priority.
The integration brings together Clue’s UK user base with Evaro’s healthcare delivery platform.
Users can transition directly from tracking their cycle in Clue to ordering contraception through Evaro’s embedded pharmacy infrastructure – accessing free NHS-funded contraception with free delivery nationwide.
The service demonstrates how asynchronous healthcare – where consultations happen online at the patient’s convenience rather than requiring real-time appointments – can solve the UK’s healthcare accessibility challenge.
The partnership pioneers embedded healthcare – where consumer brands become healthcare access points by integrating Evaro’s full-stack solution with a single line of code.
The service is available immediately to Clue users in the UK.
US$5m to transform and scale menopause education and training worldwide
A US$5m grant from the Steven & Alexandra Cohen Foundation, led by philanthropist and New York Mets Owner Alex Cohen, will support the digital-innovation phase of the Menopause Society’s NextGen Now initiative.
The grant will create a comprehensive digital ecosystem to leverage cutting-edge digital technologies, ensuring seamless access and consistent updates of educational content.
The initiative supports comprehensive training programmes for current and next generation healthcare professionals to improve the care of midlife women.
Through the NextGen Now initiative, The Menopause Society has said it is committed to reaching 25,000 healthcare professionals within the next three years and ultimately improving the lives of millions of women navigating the complexities of menopause.
The donation will further support The Menopause Society’s vision for a digital strategy for NextGen Now, through an integrated digital-learning platform, advanced virtual- and augmented-reality modules, and a dynamic mobile app.
NextGen Now is a multiphase initiative spanning several years and many projects and programmes.
To continue its success, additional support is still needed. This includes funding for research and data collection.
Progyny expands to include pregnancy, postpartum, and menopause
Women’s health company Progyny has launched its pregnancy, postpartum, and menopause programmes for global employers, available starting January 1, 2026.
The company says that the offerings complement the availability of the company’s existing and marketing-leading global fertility and family building offering, providing multi-national employers with a continuum of integrated services.
The platform is purpose-built for global markets, supporting members in their country-specific environment, helping them with expert support through stages of pregnancy, postpartum, menopause, and midlife to optimise health, productivity, and retention.
Employees uniquely have access to personalised consultations and guided programmes with Global Care Advocates, with maternal health, menopause, and mental health expertise; a curated knowledge centre for evidence-based education on symptoms and more; a country-specific navigator support for local care, regulations, policies, and protections; and, a GDPR-compliant platform.
FDA approves first medical device for women with Asherman Syndrome
Uterine health company Womed has announced that the Food and Drug Administration approved the PreMarket Approval (PMA) application of the Womed Leaf for adult women undergoing hysteroscopic surgery for symptomatic moderate to severe intrauterine adhesions, also referred to as Asherman syndrome.
Womed Leaf is the first medical device to be approved for sale in the United States for that indication.
“This is the first FDA approved barrier for these patients and marks a significant improvement for their ultimate desired outcome.”
Intrauterine Adhesions (IUAs), which refer to the pathological binding of the uterine walls, are caused by scarring of the uterus after procedures such as dilation and curettage or fibroid removal, and can occur in 20 per cent to 45 per cent of those procedures.
IUAs are a major cause of infertility, recurrent miscarriages and pain. IUA treatment is plagued with a very high recurrence rate, leaving women unsure and very anxious about their chance to conceive.
Womed Leaf is intended to reduce the reoccurrence and severity of post-surgical adhesion formation inside the uterus. It consists of a soft thin film made from Womed’s innovative polymer, which is inserted like an IUD at the end of an adhesiolysis procedure.
It expands within the cavity, preventing contact between the uterine walls, and is then naturally and painlessly discharged.
The pivotal PREG2 randomised clinical study that enrolled 160 patients with severe or moderate IUA demonstrated that Womed Leaf significantly reduced the severity of intrauterine adhesion after hysteroscopic adhesiolysis compared with no prevention method and that Womed Leaf has an acceptable safety profile.
Prototype production begins on AI-enabled device for Vulvo-Vaginal Candidiasis
Femtech medical device company Zero Candida Technologies has commenced prototype production of ZC-001.
ZC-001 the first AI-enabled therapeutic device integrating blue light therapy, targeted drug delivery, and wireless diagnostics for the personalised treatment of Vulvo-Vaginal Candidiasis (VVC).
The company has initiated production of 50 prototype units, with completion expected by Q1 2026.
The ZC-001 device is designed to offer meaningful advantages for both physicians and patients by providing personalised, at-home treatment with real-time data transmission, reducing the need for frequent doctor visits while enabling individualised care protocols.
“Every design decision was made with patient comfort and usability in mind,” said Dr Asher Holzer, CTO of Zero Candida.
“It’s the foundation for our next phase of validation and defines the technical standards for how ZC-001 will be built and tested.”
Alife Health’s AI-powered embryo selection software has received CE Mark certification under the European Medical Device Regulation (MDR), allowing it to be used in fertility clinics across Europe.
The San Francisco-based company said its Embryo Predict system, which supports embryologists in selecting the best embryo for transfer, can now be marketed across EU countries following MDR approval.
The software uses deep learning – a type of artificial intelligence that mimics how the brain processes information – to help embryologists assess embryos during IVF.
It captures embryo images, generates an AI score and ranks them according to their likelihood of resulting in a clinical pregnancy.
Traditional embryo assessment relies on manual observation of embryo morphology – the study of its shape and structure – which can vary between embryologists.
The AI tool aims to standardise this process by analysing large datasets and detecting subtle patterns beyond what the human eye can identify.
Melissa Teran, CEO of Alife Health, said: “Achieving CE Mark approval is a significant step in our mission to improve patient outcomes and expand access to fertility care.
“With Embryo Predict now available to clinics across Europe, we have moved one step closer to our goal of achieving global impact in reproductive medicine.
“We look forward to partnering with leading IVF centres across Europe to bring the benefits of AI to more patients.”
With MDR clearance secured, Alife plans to roll out Embryo Predict to selected IVF clinics across the EU, building on its existing momentum in the US, where it operates a clinical decision support platform and partners with leading fertility networks.
Alife Health develops AI-driven tools to modernise and personalise IVF.
The company has not disclosed pricing for the European market or timelines for individual country launches.
Dr Marcos Meseguer is global director of embryology research at IVIRMA, who is collaborating with Alife on innovative embryo research sponsored by the European Council.
Meseguer said: “I was impressed not only by Embryo Predict’s precision in scoring embryos, but also by the simplicity of its integration with existing laboratory hardware.
“Alife brings a level of standardisation and objectivity to embryo selection that our field needs.
“By combining human expertise with AI-driven insight we will reduce subjectivity and improve decision-making.”
A Victorian woman undergoing IVF treatment received her own embryo instead of her partner’s, Monash IVF has confirmed—marking the second reported mix-up at the fertility company in recent months.
The error, which occurred in June, was revealed in a statement to the ASX on Tuesday.
Monash IVF said the patient’s embryo was transferred “contrary to the treatment plan”, which had specified the embryo of her partner.
It follows a separate incident announced in April, when a woman at a Queensland clinic gave birth to a child conceived with another couple’s embryo.
Monash IVF said it had extended “sincere apologies” to the latest affected couple and was continuing to support them.
The Victorian health regulator has launched an investigation. The state’s health minister, Mary-Anne Thomas, said the company would be required to cooperate fully.
Thomas said in a statement: “Families should have confidence that the treatment they are receiving is done to the highest standard.”
She later told reporters Monash IVF’s “clinical governance standards are not where they should be”.
She said: “This will be quite devastating for the couple at the heart of this.
“The IVF journey can be long, torturous and very expensive. To not be respected, to not have your treatment plan followed—I can’t even imagine how that couple are feeling right now.”
The first incident was attributed to human error.
Monash IVF appointed senior counsel Fiona McLeod to lead an independent investigation, which has now been extended to cover the second case.
The latest incident has renewed concerns about safety protocols in fertility clinics.
Dr Hilary Bowman-Smart is a bioethicist at the University of South Australia.
Bowman-Smart said: “In reproductive care, trust is everything.
“This mix-up – the second reported incident at Monash IVF – risks shaking confidence not just in one provider, but across the entire fertility sector.”
Dr Evie Kendal, senior lecturer in health promotion at Swinburne University of Technology, said the cases showed how human involvement in reproduction carried risks.
She said: “Previous safeguards are clearly not up to the challenge of protecting clients against such incidents, and urgent ethical and policy guidance is needed to prevent such mistakes from occurring again.”
Monash IVF said it was introducing additional verification processes and patient confirmation steps “over and above normal practice and electronic witness systems” to restore confidence in its procedures.
It noted that while electronic witness systems were being rolled out, there were still circumstances where manual checks were required.
Associate professor Alex Polyakov from the University of Melbourne and medical director at Genea Fertility described the events as “profoundly troubling”, but added they remained “extraordinarily uncommon”.
Monash IVF has notified assisted reproductive technology regulators and its insurers about the incident.
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