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FDA clears Visby Medical ‘game-changing’ STI test

The test aims to help clinicians accurately test and treat patients in a single visit

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The US testing company Visby Medical has received FDA clearance for its “second generation” sexual health test for women.

The company has announced it received 510(k) clearance and was granted a CLIA waiver from the US FDA for its point of care (POC) test.

The product, which aims to help clinicians accurately test and treat patients in a single visit, is a fast, polymerase chain reaction (PCR) diagnostic test for the detection of sexually transmitted infections (STIs) caused by chlamydia trachomatis, neisseria gonorrhoeae and trichomonas vaginalis in women.

Although many STIs are preventable, there are more than 20 million estimated new cases in the United States each year.

In April 2022, the Centers for Disease Control and Prevention reported that STIs have reached an all-time high for the sixth consecutive year, with a nearly 30 per cent increase in gonorrhoea and chlamydia between 2015 and 2019.

“Providing more customers with access to the Visby platform will enable clinicians to make informed treatment decisions during the span of a single clinic visit,” said Dr Gary Schoolnik, an infectious disease expert and chief medical officer at Visby Medical.

“This will help reduce overtreatment and undertreatment rates, as well as the number of patients who are lost to care.

“By providing a prompt and accurate test result, the use of this test will lower the likelihood that an infected patient will develop pelvic inflammatory disease.

“It will expedite the treatment of that patient’s sexual partner, and it will reduce the spread of STIs overall.”

Mark Medlen, Visby Medical senior vice president of operations, said: “We are excited that the clearance of the second generation sexual health test will enable us to move production to our fully automated lines, allowing us to deliver more tests to eagerly waiting customers.”

Dr Denise Sweeney of Associates in Women’s Healthcare, an OB-GYN practice from Roseville, California, said the test has been “game-changing”.

“My patients come in, self-collect and get answers in the same visit,” she added.

“We’ve simplified our workflow with reduced need to chase down patients for results and pharmacy preferences and we spend less time reviewing lab results. All this has really led to a lot of satisfaction in our office.”

Insight

Topical HRT protects bone density in women with period loss – study

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Transdermal HRT best protects bone density in women with functional hypothalamic amenorrhoea, a condition that stops periods, a review of trials has found.

The meta-analysis pooled randomised clinical trials involving 692 participants and found transdermal hormone replacement therapy and teriparatide increased bone mineral density by between 2 and 13 per cent.

Functional hypothalamic amenorrhoea can follow anorexia or intense exercise. Bone mineral density measures bone strength and the amount of mineral in bone.

Around half of women with the condition have low bone mineral density, compared with about 1 per cent of healthy women, and their fracture risk is up to seven times higher.

The research was conducted by scientists at Imperial College London and Imperial College Healthcare NHS Trust.

Professor Alexander Comninos, senior author of the study and consultant endocrinologist at the trust, said: “Bone density is lost very rapidly in FHA and so addressing bone health early is very important to reduce the lifelong risk of fractures.

“Our study provides much needed comparisons of all the available treatments from all available studies.

“Clearly the best treatment is to restore normal menstrual cycles and therefore oestrogen levels through various psychological, nutritional or exercise interventions – but that is not always possible.

“The foundation for bone health is good calcium and vitamin D intake (through diet and/or supplements) but we have additional treatments that are more effective.”

When FHA is diagnosed, clinicians first try to restore periods through lifestyle measures, including psychological and dietary support, but these can fail. Guidelines then recommend giving oestrogen, though the best form was unclear.

The team reviewed all prior randomised trials comparing therapies, including oral and transdermal oestrogen, and also assessed teriparatide, a prescription bone-building drug used for severe osteoporosis.

They found no significant benefit for oral contraceptive pills or oral hormone therapy.

A recent UK audit reported that about a quarter of women with anorexia-related FHA are prescribed the oral contraceptive pill for bone loss; the study suggests using transdermal therapy instead.

Comninos said: “Our goal is simple: to help women receive the right treatment sooner and to protect their bone health in the long-term.

“We hope this study provides clinicians with better evidence to choose transdermal oestrogen when prescribing oestrogen and so inform future practice guidelines.

“Right now, millions of women with FHA may not be receiving the best treatments for their bone health.”

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Entrepreneur

US startup builds wearable hormone tracker

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Stanford graduates’ startup Clair is building a wearable hormone tracker for women, offering continuous, non-invasive monitoring.

The company, Clair, founded by Jenny Duan and Abhinav Agarwal, aims to build what its founders describe as a research-led, privacy-focused tool to help women see how hormone levels affect daily life.

Duan and Agarwal met in spring 2025 and began working on Clair shortly after. Over the past six months, they have been developing the technology and refining the company’s mission.

The device is designed to address gaps in women’s healthcare. Women remain underrepresented in medical research and clinical trials, leading to limited data and slower progress in understanding women’s health conditions.

According to Clair advisor and Stanford Medicine professor Brindha Bavan, hormone tracking in reproductive healthcare “improves our understanding of the function of and communication between the brain’s pituitary gland and ovaries or testes.

The pituitary gland is a small organ at the base of the brain that produces hormones regulating many bodily functions. The ovaries and testes are the primary reproductive organs that also produce sex hormones.

Hormonal health affects not only fertility and reproduction but also mental health, metabolism, energy levels and overall wellbeing.

Bavan said hormone tracking can “provide insight into menstrual cycle patterns and can aid with both diagnosing and assessing treatment for [various] conditions.”

“[Clair enables] patients [to] gain insight into their personal hormone fluctuations over different time periods,” Bavan said, “and share this information at healthcare visits to better understand and correlate any medical issues they are facing and avoid repeat blood draws.”

The device, which resembles a bracelet worn on the wrist, will connect to a mobile app, allowing all data processing to occur directly on the user’s phone rather than in external data centres.

“The device connects with an app so all of the processing happens on the app itself, not in a data centre like other devices. This is especially important given the current political climate around data privacy,” Agarwal said.

Clair also plans to pursue FDA approval and position itself as a medically credible device rather than solely a lifestyle product. The company is planning to launch a clinical trial at Stanford Medicine this spring.

Duan’s interest in women’s health and technology began as a Stanford undergraduate. At TreeHacks in 2024, she built apps focused on endometriosis, a condition where tissue similar to the lining of the womb grows outside of it.

She said a course on Philanthropy for Sustainable Development was particularly influential. “It was this class that sparked my interest in building a solution in [the women’s healthcare] space,” Duan said.

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Wellness

IBSA UK launches non-hormonal injectable for menopause symptoms

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IBSA UK has introduced Hyaluxelle, a non-hormonal menopause treatment for vulvo-vaginal atrophy, easing vaginal dryness and pain during intercourse.

Hyaluxelle is given as deep intradermal injections to the vulvar vestibule, the area at the vaginal opening, in two sessions one month apart, followed by clinical reassessment.

IBSA UK is the UK subsidiary of Swiss pharmaceutical company IBSA.

Vulvo-vaginal atrophy is a key feature of genitourinary syndrome of menopause, a long-term condition caused by low oestrogen that affects genital, urinary and sexual health.

At least half of post-menopausal women are affected, yet many do not seek help, often assuming symptoms are part of ageing.

The condition stems from thinning and drying of vaginal and vulval tissues linked to low oestrogen, leading to symptoms such as dryness, discomfort, altered pH and pain during intercourse.

Hyaluxelle combines high and low molecular weight hyaluronic acid, a moisture-retaining substance found naturally in the body.

The company says this creates a lower-viscosity injection at what it describes as the highest concentration available in the UK, supporting tissue hydration, firmness and elasticity.

The formulation is said to rehydrate the vulvar vestibule and create conditions for restoring tissue structure through collagen and elastin production.

Clinical studies indicate Hyaluxelle improves several vulvo-vaginal symptoms, including reductions in discomfort and pain during intercourse.

Studies also report gains in sexual function domains and a positive trend in some aspects of health-related quality of life.

Histological analyses suggest increased epithelial thickness, enhanced tissue regeneration and reduced inflammatory infiltration after the procedure. In studies, the treatment was well tolerated with no reported major complications.

Joanna, a 59-year-old woman living with severe symptoms, described the personal impact of delayed diagnosis.

She said: “I lived for years with pain, UTIs, cystitis and a loss of sensation, but every visit to my GP, even a female GP, was treated as a bladder issue.

“Nobody suggested it might be linked to the menopause or joined the dots, and none of the treatments I was given helped. Without the right information or support, I became desperate for answers.

“The symptoms affected everything, what I wore, how I exercised, how I slept, but the hardest part was the impact on intimacy with my husband.

“I withdrew from our relationship because I was scared sex would hurt, and the loss of closeness was devastating, and I no longer felt like myself.

“Women deserve clear explanations and real options when their symptoms are not getting better.”

IBSA says Hyaluxelle offers clinicians an option for women whose symptoms persist despite first-line therapies, or for those who cannot receive or choose not to receive hormonal treatments.

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