Insight
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.
Insight
Peers call on UK government to review fertility and surrogacy laws

Peers have called for law reform after two House of Lords debates on fertility treatment, surrogacy, embryo research and declining birthrates.
The first debate was put forward by crossbench peer Baroness Ruth Deech, who previously chaired the UK’s fertility regulator, the Human Fertilisation and Embryology Authority.
She discussed proposals from the HFEA to reform the Human Fertilisation and Embryology Act, along with proposals from the Scottish Law Commission and the Law Commission of England and Wales to reform the Surrogacy Arrangements Act.
She called for parliamentary scrutiny of possible changes to regulatory powers, consent rules, donor information and future scientific developments.
Baroness Deech said: “Parliament should plan by setting up a Select Committee to examine the HFEA’s proposals to expand regulatory powers, simplify consent rules, modernise donor information provisions and create a flexible framework for future scientific developments.”
Former fertility professionals were among those contributing to the debate.
Professor Lord Robert Winston, a Labour peer who founded the IVF service at Hammersmith Hospital in London, said: “Infertility is not a disease; it is actually a symptom of something wrong.”
Professor Baroness Geeta Nargund, a Labour peer, current HFEA member and former medical director of CREATE Fertility, disagreed.
She said: “Infertility is a disease, as stated by the World Health Organisation.”
Liberal Democrat peer Baroness Caroline Pidgeon highlighted regional differences in access to NHS-funded fertility treatment.
She cited figures from the Progress Educational Trust’s NHS Fertility Funding Tracker showing that only two of England’s 42 integrated care boards comply with the recently updated fertility guideline published by the National Institute for Health and Care Excellence.
Integrated care boards are local NHS organisations responsible for planning and funding healthcare services in their areas.
Baroness Pidgeon said many boards were offering only a partial IVF cycle rather than a full cycle as defined by NICE.
A full IVF cycle generally includes ovarian stimulation, egg collection and the transfer of all suitable fresh and frozen embryos created during treatment.
Crossbench peer Professor Baroness Clare Gerada, a former president of the Royal College of General Practitioners, said: “The proportion of NHS-funded IVF cycles has fallen to just under 30 per cent, the lowest level since 2008.”
She added that, in relation to IVF, “the NHS system has collapsed”.
Liberal Democrat peer Lord Monroe Palmer said it was “very ironic that it is difficult for many patients to access publicly funded fertility treatment in the very country where IVF was originally pioneered”.
Conservative peer Edward Howard, Earl of Effingham, also raised concerns about the NICE fertility guideline.
He said: “Access remains highly variable across England, because ICBs are not required to implement that guidance.”
He described the situation as “a clear gap between guidance and enforceable entitlement”.
Baroness Deech called for “automatic record sharing between clinics and the NHS central records system”.
Baroness Nargund supported this and linked the ambition to the Single Patient Record in the government’s Ten-Year Health Plan for England and the Health Bill currently before Parliament.
Baroness Pidgeon said such ambitions were at odds with the exceptional degree of medical secrecy that currently applies to IVF.
She also pointed to “a clear desire for the HFEA to be able to permit patients to give generic consent for the use of their embryos in research”.
Patients cannot currently give broad consent for unspecified future research involving their embryos.
Responding for the government, Labour peer Baroness Judith Blake said “immediate legislative reform” was not possible because “the legislative programme for this Parliamentary session is very full”.
Baroness Deech replied: “It might well take some years, but the Government really needs to set up that Select Committee and do the legislative scrutiny right now.”
A second debate on related issues followed immediately afterwards.
Baroness Nargund asked the government “what assessment they have made of the UK’s declining birthrates in an ageing population”.
She also said: “We still have a postcode lottery for IVF provision, with nearly 70 per cent of ICBs funding only one cycle of treatment.”
Responding for the government, Labour peer Lord Philip Wilson said: “The Government are committed to improving fair and equitable access to fertility services, recognising the significant emotional and health impacts of infertility.”
News
Why proven women’s health innovations still can’t find a home

By the Health Innovation Exchange
For more than a decade, femtech’s scale gap has been treated as a funding problem. What if that diagnosis is incomplete?
Despite growing attention, women founders still receive just 2 per cent of global venture funding, and years of advocacy have failed to shift the needle.
This persistence is no longer just a concern; it signals a deeper structural failure.
This is not just a funding gap. It is a system failure.
As Pradeep Kakkitill, founder and CEO of the Health Innovation Exchange (HIEx), argues, the sector continues to operate on a flawed assumption.
The belief that better support to founders alone will unlock scale overlooks the deeper structural constraints that determine whether the innovation is adopted at all.
Barriers That Go Beyond Capital
These insights are not theoretical. Global research reinforces that these challenges are not isolated, highlighting structural, financial and systemic barriers that shape how women-led and under-represented ventures access funding, markets and pathways to scale.
Importantly, these findings are not draw from research alone, but from the lived experiences of women and under-represented founders themselves.
Across HIEx-led interviews and focus group discussions conducted as part of the Reckitt Catalyst Programme, founders repeatedly described the same challenges: fragmented financing, unclear adoption pathways, repeated cycles of proof, and systems that lacked clear routes from validation to procurement and scale.
These experiences suggest that the barriers facing women-led innovation are not simply financial. They are structural.
Many high-potential ventures are not failing because funding is absent.
They are failing because the systems that determine scale, including public procurement, regulation and financing, are not built to move proven solutions beyond pilots into widespread adoption.
This is not a founder problem. It is a system design failure.
Beneath these structural constraints sits a more persistent challenge. Entrenched attitudes shaped by unconscious bias continue to influence decision making.
Across investment and public-sector systems, innovation led by women and underrepresented founders is still frequently perceived as higher risk.
These perceptions shape how opportunities are evaluated, increase the burden of proof placed on founders, and slow decision making. In practice, this results in systematically higher barriers to both funding and adoption.
Systems Unable to Absorb Innovation
Dr. Abas Hassen, lead executive officer for health innovation and quality at Ethiopia’s Ministry of Health, underscores this point.
The primary constraints are not about innovation quality, but about the systems that determine adoption and scale, including procurement, regulation, financing and delivery.
He identifies three persistent challenges: institutional resistance to change, “pilot purgatory” where solutions are repeatedly tested but not integrated into public systems, and a disconnect between what external funders support and what governments can sustain.
Ethiopia’s response reflects a broader shift. Innovation is no longer treated as isolated pilots, but as a structured component of system design.
The country’s system-led innovation model combines regulatory pathways, prioritisation frameworks and structured testing environments to embed innovation directly within the health system.
The implication is clear.
Scaling innovation is not only about accelerating individual ventures alone. It is about strengthening the systems that determine whether innovation is adopted at scale.
The Missing Middle: From Pilot to Procurement
In many low- and middle-income countries, public systems remain the largest market for health and WASH solutions, accounting for the majority of service delivery and procurement.
Yet capital is deployed through models that do not reflect this reality, as scaling depends on public-sector adoption, long procurement cycles and regulatory integration rather than rapid returns.
This creates a misalignment within the financial ecosystem, where capital is structured for faster high returns, while impact depends on long-term system integration.
At its core, the challenge is the absence of clear adoption pathways.
Without structured routes from validation to procurement and system-wide use, even effective solutions struggle to move beyond pilots.
This is the “missing middle”, the gap between early validation and large-scale adoption.
The consequences of this “missing middle” are perhaps best illustrated by the founders trying to navigate it.
Temie Giwa-Tubosun, founder and CEO of LifeBank, describes her decade-old company as an “orphan” within existing financial structures, too commercial for impact investors and too impact driven for venture capital.
Businesses operating within health systems often fall between funding models that were not designed for them.
Thato Schermer, co-founder of Zoie Health, describes a similar challenge.
Even companies with strong revenue and clear demand struggle to secure funding at the right stage, as they are assessed through frameworks that do not reflect the healthcare markets.
Across interviews and focus group discussions, these patterns were consistent.
Founders described fragmented financing, unclear adoption pathways, and repeated cycles of proof, where they are asked to keep proving their solutions without a clear route to scale.
These are not isolated challenges. They reflect how innovation is funded, evaluated and integrated across the system.
The barrier to scale is not a lack of viable solutions. It is about the systems and models that are not designed to support them.
Reducing Risk Through System Design
From an HIEx perspective, a different approach is emerging, one that focuses not on fixing founders, but on designing how systems manage risk and adopt innovation.
Rather than avoiding risk, Ethiopia is working to manage it through structured processes.
The system is “risk-aware, not risk-averse.” It uses innovation sandboxes, structured testing environments within public systems that allow new solutions to be evaluated under controlled conditions.
These mechanisms, generate decision-grade evidence while limiting system-wide exposure, creating clearer pathways from validation to adoption.
When innovations are tested within public systems, they gain institutional legitimacy. This reduces perceived risk for both governments and investors and enables more confident decision making.
From Fragmentation to Coordination
Within this context, initiatives such as Reckitt Catalyst, a multi-partner platform supporting women-led health and WASH innovation to scale, play a critical bridging role.
By connecting entrepreneurs with governments, investors and technical partners, and aligning solutions with national priorities, the programme helps to create clearer pathways from pilot to procurement and scale.
But alignment alone is not enough.
As Pradeep Kakkattil notes, the climate movement offers a useful parallel. Climate progress was not driven by evidence alone. It accelerated when investors, governments, and institutions began treating inaction as the greater risk.
Sustained pressure exposed the cost of doing nothing, redefined how risk was assessed and ultimately reshaped capital allocation and policy decisions.
Women’s health and WASH innovation is now at a similar inflection point.
Despite years of evidence and advocacy, outcomes such as women receiving a fraction of global funding persist.
This is not due to a lack of solutions. It is because the systems governing investment, adoption and scale have not been sufficiently challenged.
What is required is not incremental progress.
It is a shift in what the system tolerates – how risk is defined, how capital is allocated, and how accountability is enforced.
A System at an Inflection Point
The implications are clear.
Investors must move beyond rigid funding models and deploy capital aligned to how health systems scale. Governments must build clearer pathways for testing, procurement and adoption.
Ecosystem actors must shift from supporting individual ventures, to enabling system-level integration.
The persistent funding gap is not a result of slow progress; it reflects a system operating exactly as designed. Incremental change will not shift outcomes.
What is required is a fundamental reset of how femtech is financed and scaled: from passive investment to active market-shaping, where capital, policy, and procurement work together to create real pathways to adoption.
Until that shift happens, the sector will continue to produce innovation that the market is not structured to absorb.
Insight
British women among angriest in Europe, health survey reveals

British women are among the angriest in Europe, a global health survey has revealed.
More than 20 per cent of women in Britain said they had experienced feelings of rage for much of the previous day.
British women were also 47 per cent more likely to say they felt angry than a year earlier.
The findings were published in the Hologic Global Women’s Health Index, a yearly league table based on polling of more than 76,000 women and girls aged over 15 worldwide.
Anna O’Sullivan, co-founder of women’s health awareness group CensHERship and founder of the FutureFemHealth news platform, told the Daily Mail: “These figures reflect years of long waiting lists, delayed diagnoses and women’s health being treated as an afterthought.
“We’ve seen a significant increase in awareness and discussion about women’s health over the last few years, but access to care has not kept up with that.
“These findings should be a wake-up call that it’s time for long-term, sustainable investment to ensure women can access timely healthcare, trusted information and earlier diagnosis before conditions become more complex and costly to treat.”
The data suggested anger levels among British women have risen sharply.
Rates across the rest of Europe, however, remained broadly the same.
The survey, which involved more than 140 countries, found three in 10 UK women said they felt sadness, compared with the EU average of 25 per cent.
The data, collected in February 2024 and released this week, also showed that around four in 10 women in both the UK and EU felt worry.
A third of women in the UK reported being in pain, up 10 per cent on the previous year.
Three in 10 women also said they lived with chronic health problems, up seven per cent on the year before.
Chronic health problems are long-term conditions that may need ongoing care or management.
Health experts said women in the UK were increasingly frustrated by the gap between the NHS care they expected and the care they received.
The report took a snapshot of the national mood, with participants asked about the emotions they had experienced “during a lot of the day yesterday”.
The UK placed sixth among 37 European countries for anger.
The highest levels were recorded in Malta, where 26 per cent of women reported feelings of rage, followed by Greece at 25 per cent, the Czech Republic and Albania at 23 per cent, and Spain at 22 per cent.
Ireland ranked at 18 per cent, while Germany, France and Switzerland each reported 17 per cent.
Britain has also slipped in Hologic’s overall global rankings for women’s health.
The UK is now 48th, close to dropping out of the top third of countries worldwide, after ranking 40th out of 142 countries last year.
Taiwan ranked first, followed by Latvia, Japan, Vietnam and Poland. Singapore, Germany and Austria were also among the leading countries.
Tim Simpson, a senior manager at Hologic, said: “Women are telling us they want earlier diagnosis and faster access to care.
“Improving women’s health will take continued commitment from policymakers, the NHS, clinicians and industry working together to deliver the changes women are asking for.”
A separate Hologic survey carried out last month found that almost 70 per cent of women had faced delays seeking NHS care in the past five years.
Two in five said difficulties accessing healthcare had left them feeling frustrated or anxious.
The survey’s findings reinforced official figures showing that Britain has become more anxious since before the pandemic.
The Office for National Statistics said 22.5 per cent of UK adults reported “high anxiety yesterday” between July and September 2024, up from 20.4 per cent in the same period in 2019.
Among women, the figure was 26.3 per cent, compared with 18.5 per cent among men.
A Department of Health and Social Care spokesperson said: “It is unacceptable that the UK continues to lag behind other countries when it comes to women’s health.”
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