Women's Health
The US FDA is updating its menstrual products guidance for the first time since 2005, adding new recommendations for menstrual cups as well as additional testing guidelines. The document also reflects a new awareness of the potential risks of contaminants within menstrual products.
Advocates spanning the spectrum of women’s health met in Manhattan to discuss the gender disparities that remain in healthcare and how public policy can correct them and the enormous ROI investors in women’s health can potentially reap.
Netherlands-based company plans to spend approximately two years on preclinical studies followed by pivotal trials involving 400 to 500 women across 12 hospitals. These large-scale clinical studies are expected to begin around 2028.
Armor Medical’s wrist-worn wearable detected postpartum hemorrhage five times earlier than standard care in earlier studies. After surviving near-fatal hemorrhage herself, co-founder/CEO Kelsey Mayo aims to bring the device to market in 2028.
At the MedTech Conference, the CEOs of Stryker, Hologic and Insulet said during a panel AI is now central to their business strategies, from creating new medical devices to streamlining workflows and administrative tasks. Stryker’s CEO Kevin Lobo plans a business unit focused on AI-enabled tech.
The US FDA has approved Medtronic’s Altaviva, a subcutaneous device implanted near the ankle that offers a new treatment option for adults with urge urinary incontinence.
Device safety advocate Michelle Llamas says the FDA’s device review system leaves women at risk, citing weak oversight of 510(k) clearances, delayed safety warnings, and underrepresentation in trials. Her updated report urges stronger monitoring, transparency, and safeguards.
Medtech Insight spoke with Sanjay Kakkar, Tensive CEO, about the firm’s breast tissue regeneration implant and its surgical benefits, including a reduced operation time of 74 minutes. He anticipates regulatory approval for Regenera in early 2027.
Israeli device firm Fairtility recently obtained US FDA clearance for the CHLOE platform, which uses AI to make embryo assessments performed as part of in vitro fertilization more transparent, efficient and reliable.
Salient's inflammatory bowel disease test, built on the start-up’s Signal platform, is planned to launch in March 2026. The company leverages rich data from existing wellness tests to develop signatures, focusing on conditions that are often misdiagnosed and disproportionately affect women.
An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.
The National Advertising Division (NAD) alerted Agendia to improve disclosure regarding a physician endorsing its MammaPrint test. The physician's ties to Agendia were inadequately revealed in LinkedIn posts.
Daye is launching an at-home reproductive hormone testing service in the UK, utilizing a painless upper arm blood collection method. The product’s UKAS lab accreditation helps build credibility with healthcare providers.
IMMA’s transvaginal at-home ovarian stimulation monitoring system using ultrasound and AI image analysis increases the chances of early IVF success. It won the Biomed Israel 2025 IVD start-up showcase award. Further potential applications could follow, cofounder/CEO Beatrice Chemla said.
The Lioness non-surgical silicon ring implant is designed to put an end to pre-term births, sparing maternal anguish and saving health system costs. PregnanTech won the Biomed Israel 2025 medtech start-up award, and Limor Sandach told In Vivo how a non-digital technology beat off stiff competition.
An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.
Thena Capital, the first UK-based early-stage specialist medtech firm, has made its first investment since closing its £50m fund. Medtech Insight spoke with general partner Pamela Walker Geddes to gain insight into Thena Capital’s investment strategy.
NHS England will offer at-home cervical cancer self-testing kits to people who are overdue for routine screening by six months. The Department of Health and Social Care identified four HPV collection and testing combinations with highest accuracy.
Cecilia Lindgren, Aneira Health’s co-founder and chief science officer, said that the company has “redesigned the diagnostic model.” The subscription-based platform offers clinical-grade and AI diagnostics alongside clinical consultation.
DeepLook Medical recently announced the commercial rollout of DL Precise, an AI-powered imaging platform that enhances breast cancer screening, at major healthcare institutions across the US.