Plus: FDA approves norelgestromin and ethinyl estradiol, Johnson & Johnson settles for $5.5B, and Hertility reports reproductive health knowledge gaps.
Natural Cycles received its sixth FDA clearance for an updated AI-powered fertility algorithm, expanding regulatory pathways for algorithm-based contraception and fertility solutions for clinicians. Expanding contraceptive access and options for patients, the FDA also approved the low-dose, once-weekly norelgestromin and ethinyl estradiol transdermal patch. Legal challenges in women's health are evident as Johnson & Johnson faces a $5.5 billion settlement for talcum powder lawsuits concerning 76,000 plaintiffs asserting ovarian cancer, impacting femtech operators and clinicians involved in women's health. Five takes inside, plus a quick-hits roundup.
VIA FemTech Insider
Natural Cycles received its sixth FDA clearance for an updated version of its AI-powered NC° Fertility Algorithm. The company previously secured FDA clearances for its birth control app, integrations with Oura Ring and Apple Watch, and over-the-counter availability. The next-generation algorithm combines statistical modeling with machine learning trained on tens of millions of real-world fertility data points. This demonstrates a continued regulatory pathway for algorithm-based contraception and fertility solutions.
Read the full story →
— The Luteal Editorial Team
VIA Contemporary OB/GYN
The FDA approved norelgestromin and ethinyl estradiol, a low-dose once-weekly contraceptive patch, for contraception. This product will expand contraceptive options for patients and providers.
Read the full story →
— The Luteal Editorial Team
VIA FT Health
Johnson & Johnson will pay $5.5 billion to settle a US talcum powder lawsuit. Approximately 76,000 plaintiffs asserted the drugmaker's products led to ovarian cancer. This event impacts femtech operators and clinicians involved in women's health.
Read the full story →
— The Luteal Editorial Team
VIA NHS England News
Pharmacies supplied almost 305,000 doses of the emergency contraceptive pill between October 2025 and March 2026. Hundreds of thousands of women accessed the morning-after pill at high street pharmacies in the first five months since the NHS made it available free-of-charge. This indicates a significant uptake in publicly funded contraceptive services.
Read the full story →
— The Luteal Editorial Team
VIA FemTech Insider
Hertility's fourth annual Reproductive Report analyzed over 500,000 patient assessments. The report found that 70% of women used a wearable to monitor health and 51% used cycle-tracking tools, yet persistent knowledge gaps regarding menstrual cycles and fertility remain. This indicates a market opportunity for solutions addressing comprehensive reproductive health education and specialist care access for femtech operators.
Read the full story →
— The Luteal Editorial Team