Plus: New research links ISM2 to preeclampsia, DNB launches women's health fund, and menopause is under-documented in EHRs.
The FDA granted Breakthrough Therapy Designation to certolizumab pegol for preventing adverse pregnancy outcomes in women with antiphospholipid syndrome, accelerating a critical treatment path for clinicians. This regulatory advance coincides with a new international standard from ISO providing workplace guidance for menstruation and menopause, creating a new framework for employers. Concurrently, a study of nearly 396,000 women reveals menopause is documented in only 7% of electronic health records, highlighting a significant data gap for healthcare providers. Five takes inside, plus a quick-hits roundup.
VIA FutureFemHealth
DNB, a mainstream Norwegian bank, launched a dedicated women's health fund. This week, iPremom raised €15 million in a seed round, GonGlobal secured A$1.2 million, and SiccaNova raised ¥1.25 billion (approximately US$8.1 million) for femtech solutions. Tensive secured up to €20 million from the European Investment Bank for breast reconstruction technology, while Pulsenmore completed European registration for its at-home IVF ultrasound system. These investments and market expansions indicate continued growth and innovation across fertility, chronic conditions, and general women's health.
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— The Luteal Editorial Team
VIA PR Newswire Health
On September 7, 2026, the International Organization for Standardization (ISO) launched ISO 45010 – Occupational health and safety management — Menstruation and menopause in the workplace — Guidance. This new standard is the world's first International Standard to provide guidance for menstruation and menopause in the workplace. This creates a new framework for employers regarding women's hormonal health.
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— The Luteal Editorial Team
VIA Contemporary OB/GYN
FDA granted Breakthrough Therapy Designation to certolizumab pegol for preventing adverse pregnancy outcomes. This designation impacts women with antiphospholipid syndrome.
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— The Luteal Editorial Team
VIA Nature Medicine
Lower maternal serum levels of isthmin 2 (ISM2) in early pregnancy predict preeclampsia and fetal growth restriction (FGR). ISM2 is essential for trophoblast invasion; impaired invasion of the uterus by trophoblasts links to both conditions. Preeclampsia and FGR cause fetal morbidity and mortality globally. This research indicates a potential biomarker for early detection.
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— The Luteal Editorial Team
VIA FemTech World
A study of nearly 396,000 women found menopause documented in only about 7% of electronic health records. Researchers identified approximately 193,000 menopause observations in survey data compared to around 28,000 diagnoses in EHR data. This means menopause appeared almost seven times more often in participant surveys than in EHRs. For femtech operators, clinicians, and investors, this highlights a significant gap in current health data and potential for solutions to capture menopause status.
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— The Luteal Editorial Team