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.