Cardiovascular conditions lead pregnancy-related deaths, and CA$5M targets women's heart/brain health gaps. Plus: The anna perimenopause app launches across 39 markets.
Heidi Overton's years of loyalty to President Trump helped her become his pick to lead the U.S. Food and Drug Administration, but Senator Bill Cassidy signals he may not vote for her confirmation, impacting regulatory stability for drugmakers. Persistent supply constraints for transdermal estrogen patches continue as 70% of FDA-approved medications lack human pregnancy data, challenging patient care and research. This highlights ongoing gaps in medication safety research for pregnant and lactating individuals and for women's health overall. Five takes inside, plus a quick-hits roundup.
VIA STAT News
Last November, severe supply constraints for transdermal estrogen patches began after the FDA removed strong safety warnings from hormone replacement therapy, triggering a surge in prescriptions. Drugmakers face manufacturing challenges for these complex patches, leading to shortages. Separately, Heidi Overton's potential nomination to lead the FDA faces Senate confirmation issues, with Senator Bill Cassidy signaling he may not vote for her. Limited manufacturing capacity for estrogen patches means many women are switching brands and dosages, impacting patient care.
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— The Luteal Editorial Team
VIA FemTech Insider
Heart & Stroke and Brain Canada committed CA$5 million over five years to the RENEW Network, the third recipient of the Research Network of Excellence in Women’s Heart and/or Brain Health program. Dr. Jodi Edwards leads the RENEW Network. This network aims to address key care gaps in women’s heart and brain health. This funding supports critical research for femtech innovators targeting cardiovascular and neurological health in women.
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— The Luteal Editorial Team
VIA FemTech World
The anna perimenopause app launched across 39 markets in the UK and Europe. The app costs £13.99 a month or £99.99 a year in the UK, using existing wearable data like sleep and heart rate to provide lifestyle recommendations. Developed with an advising clinician, the app’s recommendations draw on over 300 published studies. This launch demonstrates a new approach for femtech operators in integrating consumer health data for perimenopause support without external investment.
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— The Luteal Editorial Team
VIA Contemporary OB/GYN
A 20-year PMSS analysis identifies cardiovascular conditions as the leading cause of pregnancy-related death. This research highlights critical areas for intervention in maternal health, providing direction for femtech operators, clinicians, and investors targeting maternal mortality reduction.
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— The Luteal Editorial Team
VIA Society for Women's Health Research
An estimated 90% of women take at least one prescription drug during pregnancy, yet 70% of FDA-approved medications lack human pregnancy data, and 98% have insufficient data for infant risk. Research inclusive of pregnant and lactating populations continues to lag. A narcolepsy and pregnancy study, published in 2025, found 69% of respondents used medication preconception and 39-46% during pregnancy, with 40% reporting worsened symptoms postpartum and 50% during breastfeeding. This data underscores persistent gaps in medication safety research for pregnant and lactating individuals, impacting patient care.
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— The Luteal Editorial Team