Menopause
Osteoporosis screening tool secures FDA breakthrough designation
In the US alone, 50 per cent of women over the age of 50 will experience a fracture caused by osteoporosis
London-based health tech company Naitive Technologies has received breakthrough device designation from the US Food and Drug Administration (FDA) for its osteoporosis screening tool.
OsteoSight aims to address the unmet need for earlier diagnosis of osteoporosis, a condition characterised by a progressive decrease in bone density, which is often diagnosed when a patient suffers a debilitating fragility fracture.
Worldwide, a fragility fracture caused by osteoporosis occurs every three seconds, costing global healthcare systems US$400bn annually.
In the US alone, 50 per cent of women and 25 per cent of men over the age of 50 will experience a fracture caused by osteoporosis.
The Bone Health and Osteoporosis Foundation reports that fragility fractures are responsible for more hospitalisations than stroke, breast cancer, and heart attacks combined. Despite this, it is estimated that up to 75 per cent of those affected remain undiagnosed and untreated.
Menopause significantly speeds bone loss and increases the risk of osteoporosis in women. During the menopausal transition period, the drop of oestrogen, a hormone essential for healthy bones, leads to a rapid decrease in bone density, resulting in osteoporosis.
OsteoSight aims to enhance detection rates by using the signals contained within X-rays that are taken every day, often for unrelated concerns.
By including an estimate of bone density, along with an osteoporosis classification based on World Health Organization (WHO) guidelines, into the radiology report, Naitive says its technology could alert physicians sooner to their patient’s bone health.
“While treatments exist that can help slow the progression of bone loss, the biggest challenge we face is the persistent underdiagnosis of osteoporosis and low bone density,” explained Robert Pignolo, Professor of Medicine, Geriatric Medicine and Gerontology at the Mayo Clinic and member of the scientific advisory board of Naitive Technologies.
“Patients are still being diagnosed after a fracture, instead of during a period of timely intervention. By screening patients who are having routine X-rays, we have a real opportunity to identify early bone loss and osteoporosis and prevent fractures.
“I’m delighted that the FDA has seen OsteoSight’s potential, and I’m excited to see the difference it will make in clinical practice.”
The FDA’s Breakthrough Device Program is intended to provide patients with more timely access to medical devices that have the potential for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
As part of the programme, the FDA will expedite development, assessment, and review of OsteoSight for regulatory clearance.
Will Briggs, founder and CEO of Naitive, said: “We are thrilled that OsteoSight has received Breakthrough Device Designation.
“It’s a key milestone for our technology and validates our strong belief that OsteoSight has the potential to revolutionise the way we find patients at-risk for osteoporosis.
“We look forward to bringing this technology to market and helping improve patient outcomes.”
News
Awards to spotlight leaders in menopause innovation
Femtech World is to celebrate game-changing menopause innovations at its global awards event.
The Femtech World Awards, now in their third year, celebrates the brightest lights in women’s health innovation.
The event celebrates some of the best examples of leadership, innovation and impact in key areas that affect women’s health and wellbeing.
The winner of the Menopause Innovation of the Year award will have shown exceptional innovation in addressing the health, wellbeing and quality-of-life needs of people navigating perimenopause, menopause and beyond.
Consideration will be given to impact, inclusivity accessibility and the ability to break stigma while delivering meaningful solutions.
This award celebrates those leading the way in redefining how menopause is understood and supported across healthcare and society.
The award is sponsored by Cross-Border Impact Ventures (CBIV) – an impact venture capital firm on a mission to revolutionise venture investing in health technology.
CBIV invests in early-growth stage health technology companies commercialising medical devices, diagnostics, therapeutics, and digital health innovations and leveraging cutting-edge technologies like Artificial Intelligence (AI) and Machine Learning (ML).
All innovations CBIV finances are relevant to women’s, children’s, and adolescents’ health and located in North America and Europe, with the ability to scale technologies to emerging markets.
CBIV is driven by the belief that good health should not be restricted by gender, age, race, wealth, or borders and seeks to expand access to their portfolio’s world class technologies inclusively and globally.
Annie Thériault, managing partner, Cross-Border Impact Ventures , said: “Being part of the FemTech World Awards gives us a front-row seat to the most exciting breakthroughs in women’s health.
“It’s a powerful way to stay connected to the pulse of innovation and the future of care.”
Find out more about the awards and enter for free here.
Insight
Women’s health could unlock US$100bn by 2030
Addressing women’s health could unlock US$100bn by 2030 in the US alone, a new report has found.
The World Economic Forum has published its Women’s Health Investment Outlook to highlight undercapitalised opportunities in women’s health.
A Boston Consulting Group analysis cited in the report estimates that treating four major conditions that disproportionately affect women could unlock this value by 2030.
The four areas are cardiovascular disease (heart and blood vessel disease), osteoporosis (bone thinning), menopause and Alzheimer’s disease.
These common, high-burden conditions remain underserved.
The report notes that, despite women making up half the global population, women’s healthcare attracts only six per cent of private healthcare investment, and companies focused exclusively on women’s health receive less than one per cent.
Around 90 per cent of current investment is concentrated in reproductive health, maternal care and women-specific cancers.
The authors say the true burden and potential of women’s healthcare have been obscured by fragmented data, historical bias, a lack of women in relevant leadership roles and misaligned incentives.
Half of private investments in women’s health-specific companies are at pre-seed or seed stage, and the sector is gaining momentum.
The report points to acquisitions in pelvic health, diagnostics and rising institutional interest in scalable platforms.
Six areas show strong potential for investment: women’s cancer therapeutics; virtual women’s healthcare and benefits management; remote maternal health monitoring; women-focused mental health platforms; women-first longevity and wellness concierge services; and wearables and platforms for women’s metabolic health.
Given the spa and wellness sector’s majority-female clientele, operators could host selected treatments if they extend their facilities.
Suppliers and innovators can also play a key role in creating and adopting women’s healthcare technologies, with devices to support pelvic health already supplied to high-end health clubs and spas to address continence and pelvic pain.
The report was published in collaboration with Boston Consulting Group, with contributions from the investment community, healthcare professionals and others.
Fertility
Round up: First wearable detects symptoms of perimenopause, and more
Femtech World explores the latest business developments in the world of women’s health.
First wearable detects and decodes the symptoms of perimenopause
AI-driven women’s health company, IdentifyHer, has launched Peri, the world’s first wearable designed to detect and decode symptoms of perimenopause.
“75 per cent of perimenopausal women experience life-disrupting symptoms, yet perimenopause is treated like a mystery or an inevitability that women simply have to power through,” said Heidi Davis, co-founder of IdentifyHer.
“We reject this. Women deserve real data, validation, and support during this profoundly overlooked stage of life
“With Peri, we are pioneering a new era of women’s healthcare; one where women are in control of their health and equipped to manage the symptoms that shape how we feel – physically, mentally and emotionally.”
For most women perimenopause begins in the early to mid-40’s and brings wide-ranging symptoms that are often dismissed by healthcare providers.
Using biosensing technology and AI-driven analytics, Peri is a wearable device that passively tracks physiological signals to identify perimenopause symptoms and delivers personalised insights.
It helps women address perimenopausal challenges like anxiety, hot flashes, sleep disruption, nights sweats and more – issues that could have long-term health implications.
The device profiles these symptoms across the menstrual cycle, examining their interrelationships, and tracking changes over time.
“Heidi and I first launched IdentifyHer with the mission to support women’s long-term health, and immediately recognised that to do this, we need to address the gap in perimenopause symptom data,” said Donal O’Gorman, COO and co-founder of IdentifyHer.
“Our goal with Peri is to demystify perimenopause, but more importantly, to empower and reassure women they are not alone in what they’re feeling and it is possible to take proactive action towards their health.”
Emm raises £6.8m to launch world’s first smart menstrual solution
UK-based biowearable tech company, Emm, has raised £6.8m in an oversubscribed seed funding round, to bring the world’s first smart menstrual cup and connected app to market.
Creating a new category of “smart menstrual care”, Emm will equip users to understand their individual menstrual baseline and track key metrics for personalised insights into their menstrual health.
The funding will support Emm in bringing the product to market and accelerating the pathway to further clinical product development, as the business moves to transform the research, diagnosis and treatment of reproductive and menstrual health conditions.
Results published on potential endometriosis treatment
Biotech company Hope Medicine has announced that the results of a proof-of-concept Phase II clinical trial evaluating HMI-115 (a human monoclonal antibody targeting the prolactin receptor) for the treatment of endometriosis-related pain have been published in The Lancet Obstetrics, Gynaecology, & Women’s Health.
The research, carried out in collaboration with Peking University, Peking Union Medical College Hospital, Shandong University, and other institutions, aimed to evaluate the safety, tolerability, and preliminary efficacy of HMI-115 in premenopausal women with moderate to severe endometriosis-related pain.
Results showed that at the end of the 12-week treatment period, dysmenorrhea NRS scores decreased by 41 per cent, 34 per cent, and 27 per cent in the 240 mg, 120 mg, and 60 mg HMI-115 groups, respectively, compared to the 18 per cent reduction in the placebo group.
Non-menstrual pelvic pain NRS scores also decreased across all HMI-115 dosage groups, with sustained efficacy observed at Week 25.
The company says that percentage reductions of dysmenorrhea and non-menstrual pelvic pain in the 240 mg group was statistically significant compared to placebo.
Additionally, HMI-115 groups showed improvements in the Endometriosis Daily Impact Pain (EDIP) scores and reduced use of NSAID rescue medications.
In terms of safety, the incidence of treatment-emergent adverse events (TEAEs) was 56 per cent, 59 per cent, 75 per cent, and 37 per cent in the 60 mg, 120 mg, 240 mg HMI-115 groups, and placebo group, respectively.
The most common adverse events included injection site itching and rash, dizziness, nausea, nasopharyngitis, and headaches.
No treatment-related deaths or serious adverse events were reported. Unlike existing hormonal therapies, HMI-115 did not cause hypoestrogenic side effects such as hot flashes or depression, and bone mineral density and key sex hormone levels remained stable during treatment.
This study is the first to clinically validate the potential of blocking prolactin receptor signaling to alleviate endometriosis-related pain.
Its non-hormonal mechanism of action avoids interference with ovulation and menstrual cycles, offering a promising new option for patients with fertility intentions.
The research team stated that these findings provide a strong foundation for initiating longer-duration Phase III trials to further evaluate the clinical benefits and risks of HMI-115.
A month of milestones in breast imaging innovation
Koning Health has said that October marked a substantial month for Koning in its mission to expand access to non-compression breast imaging.
The last several weeks saw the continued expansion of Koning’s technology to new and diverse settings across the country, including the official launch of Gnosis Dx, which introduced a mobile breast imaging and diagnostics platform powered by the Koning Vera Breast CT (KBCT) on the West Coast.
Designed to travel directly into communities, the Gnosis trailer is meant to reduce barriers to early detection and address disparities in access in the state of California.
On Manhattan’s Upper East Side, Pink Medical celebrated its grand opening this month with a ribbon-cutting event led by fashion icon Nicole Miller. This New York City location aims to redefine the breast imaging scene in the Big Apple.
Koning’s installation at Mount Sinai Medical Center in Miami brought the Vera system to one of Florida’s most respected medical institutions.
The device will be used both clinically and for research, advancing the understanding of breast CT’s role in precision detection and patient-centered imaging.
Koning continues to expand its international reach as the only breast CT manufacturing company that has received global critical regulatory and quality achievements including Koning’s 3D breast imaging system remains the only FDA-approved breast CT device commercially available for diagnostic use in the US.
The company is also seeing progress advancing in Australia (TGA) and through Europe’s GMED for CE Mark.
-
Features4 weeks agoWomen’s health enters a new era – the trends shaping femtech in 2026
-
Insight3 weeks agoDesigner perfumes recalled over banned chemical posing fertility risk
-
Features4 weeks agoBest menopause apps and products for 2026
-
Insight1 week agoParents sue IVF clinic after delivering someone else’s baby
-
Insight2 weeks agoWomen’s health could unlock US$100bn by 2030
-
Insight4 weeks agoHigher maternal blood pressure increases risk of pregnancy complications, study finds
-
Entrepreneur4 weeks agoXella Health closes US$3.7 million in pre-seed financing
-
Insight4 weeks agoInside the first wave of speakers confirmed for Women’s Health Week USA 2026






