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Start-up wins FDA breakthrough designation for at-home cervical cancer screening solution

Teal Health aims to make it easier for women to collect cervical cancer screening samples from home

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The US healthcare start-up Teal Health has received breakthrough device status from the US Food and Drug Administration (FDA) for its at-home cervical cancer screening solution.

The Teal Wand is a device that aims to help women collect their own vaginal sample for cervical cancer screening from their home or health clinic, without the need for an invasive exam.

FDA breakthrough, which was awarded after reviewing Teal Health’s midpoint clinical trial data, will grant the start-up priority status when it submits its final study data for FDA review.

The programme helps patients have more timely access to medical devices that could provide more effective diagnosis or treatment of life-threatening diseases and for their potential to benefit populations impacted by healthcare disparities.

With one in four US women not up-to-date on their cervical cancer screening, Teal Health says this FDA breakthrough designation is particularly significant in that it is aimed to increase access for people who rarely or never screen or who can’t undergo a standard exam with the speculum by having an option to screen themselves at-home or in more convenient locations.

Kara Egan, co-founder and CEO of Teal Health, said: “I am so grateful to the amazing team at Teal, our hardworking PIs and sites, the supportive participants in our study, and the FDA for recognising the importance of Teal’s solution to help close the women’s cervical cancer screening gap in the US.

“The speed of our study shows that if you design for and engage with women to advance women’s health, you’ll be met with resounding enthusiasm from this group that has been overlooked and under researched for far too long.

“This study and breakthrough designation is an important moment for women’s health.”

Late last year, Teal Health followed its initial study with a nationwide clinical trial, titled SELF-CERV, which included 17 leading health organisations and more than 600 participants.

The research was designed to validate the performance of the Teal Wand and compare results against a clinician collected sample with a speculum and brush.

The study, which completed enrolment for its initial FDA indication this month, received an overwhelming response from women, exceeding initial enrolment goals.

Lead SELF-CERV enroler, Clair Kaplan, director of clinical research and principal investigator at Planned Parenthood of Southern New England, said: “The Teal Wand and self-collection really resonated with our patients and they were excited to be a part of the SELF-CERV trial.

“We saw upwards of an 80 per cent enrolment rate, which more than met our expectations. I am honoured to have been part of the efforts to advance cervical cancer screening and create more options for patients to get the care they need.”

Cervical cancer is preventable and is curable 92 per cent of the time. However, it is the second leading cause of cancer death among women aged 20-39 and incidence is increasing among women aged 30-44.

More than half of cervical cancer cases are in people who are not routinely screened, which is in large part due to barriers such as discomfort during the exam, lack of information, time and access.

Studies show that women of all races and socioeconomic levels experience these barriers, with native American, black and Hispanic women resulting in higher under-screened rates.

Self-collection, which has already been adopted in countries such as Australia, is thought to increase access to screening.

Trena Depel, vice president of clinical and regulatory at Teal Health, said: “FDA’s recognition of the Teal Wand as a breakthrough device acknowledges the important public health benefit that self-collection for cervical cancer screening can have on those who are rarely screened or who do not participate in clinician-based screening for cervical cancer.

“The clinical performance of the Teal Wand shows promise that an at-home self-collection device is possible in the near term and Teal looks forward to working closely with FDA to expedite this option to eligible women and people with a cervix.”

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Endometriosis documentary profiles stars including Marilyn Monroe and Amy Schumer

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A non-profit has launched an endometriosis documentary featuring Amy Schumer and Marilyn Monroe as it pushes for changes in how the condition is treated and understood.

The Endometriosis Collective has launched to change how endometriosis is researched, treated and understood, starting with a documentary featuring stories from people including Amy Schumer and Marilyn Monroe.

The feature-length documentary, “End of the Cycle”, will premiere in New York on Tuesday, and The Endometriosis Collective is making the film free to stream online.

Schumer, a comedian, writer and actor, has previously spoken of how endometriosis left her “on the floor in pain, vomiting from the pain, the pain that nobody can see.”

Schumer is one of several celebrities featured in the documentary. Other contributors include dancer Julianne Hough, Olympic medallist Brittany Brown and actors Janel Parrish and Folake Olowofoyeku.

The Endometriosis Collective timed the documentary premiere to coincide with the 100th anniversary of Marilyn Monroe’s birth.

Monroe, who died in 1962, starred in films such as “Some Like It Hot” and “Gentlemen Prefer Blondes.”

According to a biography published in 1985, Monroe’s endometriosis was so severe that it destroyed her marriages, her wish for children, her career and ultimately her life.

The Endometriosis Collective said the documentary shares newly uncovered information about Monroe’s experience with endometriosis.

The non-profit said the information connects Monroe’s story to the experiences of women across generations, highlighting how far awareness, research and care still have to go.

A representative of the Marilyn Monroe Estate said: “By sharing this part of her story through ‘End of the Cycle,’ we hope to honour her legacy in a way that brings visibility to endometriosis, encourages more open dialogue and helps inspire the research needed to create change.”

As part of the premiere, The Endometriosis Collective is holding a panel discussion.

Schumer, Brown and Olowofoyeku, the documentary’s co-directors Sammy Jaye and Soraya Simi, and medical experts are due to be part of the premiere.

AbbVie’s Orilissa and Sumitomo Pharma’s Myfembree are among the approved drugs for endometriosis pain.

Hough, one of the participants in the documentary, starred in an Orilissa campaign in 2017.

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Bridging the metabolic wealth gap: The telehealth platform bypassing insurance to democratise care

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As weight-loss treatments remain locked behind prohibitive paywalls, a new direct-pay initiative is cutting costs in half for low-income patients, and it could provide a new blueprint for health equity.

It is one of the most persistent, frustrating paradoxes in modern healthcare: the medical innovations most capable of addressing widespread chronic conditions are overwhelmingly priced out of reach for the populations most vulnerable to them.

Nowhere is this more evident than in the current landscape of metabolic health and weight management.

As state governments and insurance providers increasingly restrict coverage for advanced weight-loss medications due to skyrocketing costs, a stark dividing line has emerged. Clinical need is no longer the primary factor in who receives treatment. Affordability is.

This financial barrier disproportionately impacts women, who not only face high rates of metabolic conditions but also frequently serve as the primary caregivers in their households.

For a single mother managing childcare, grueling work hours, and the relentlessly rising cost of living, personal well-being is often the first casualty of a tight budget.

These patients are forced into a holding pattern, watching their conditions progress year after year while highly effective, life-changing treatments remain separated from them by a paywall.

Now, a telehealth platform called Amble Health is attempting to dismantle that wall by bypassing the traditional insurance apparatus entirely.

A Structural Shift for Access

Today, Amble Health announced the launch of the Amble Cares Program, a national initiative designed to cut the cost of medical weight-loss treatments in half for low-income Americans.

The programme arrives at a critical inflection point.

Today, roughly one in eight U.S. adults have utilized advanced metabolic medications, according to a recent KFF Health Tracking Poll.

This surge in adoption has driven a fundamental shift in preventative care, but the distribution of that care has been deeply uneven.

Through the Amble Cares Program, eligible patients can access comprehensive medical weight-loss programmes, which may include prescription medications if clinically appropriate, at up to 50 per cent below standard rates.

To ensure the discounts reach the intended demographic, eligibility is determined by an independent, third-party verification partner, based on verified financial need.

The programme explicitly prioritises individuals and families with limited disposable income, including parents and guardians whose financial flexibility is tied up in providing for dependents.

Once verified, patients are connected directly to licensed clinicians to begin treatment immediately, stripping away the friction of waiting periods.

“Healthcare should not be a luxury item,” said Joey Stiver, CEO of Amble Health. At Amble, we believe that a patient’s zip code or income shouldn’t dictate their metabolic health outcomes.

“The Amble Cares Program is our direct response to the cost of living crisis, moving beyond talk of ‘affordability’ to actually delivering it to the people the traditional system has left behind.”

The Direct-Pay Trade-Off

However, this rapid, lower-cost access comes with a significant structural trade-off.

To achieve these price reductions and eliminate the administrative delays, denials, and red tape associated with traditional healthcare, Amble Health operates strictly as a direct-pay platform.

This means participants cannot use outside coverage. The programme does not accept Medicaid, Medicare, commercial insurance, or even HSA/FSA funds.

For some patients, being entirely locked out of utilizing their existing health benefits may present a new kind of hurdle.

But for those who have already found themselves abandoned by traditional coverage networks, facing outright denials, unnavigable prior authorisations, or insurmountable deductibles, the direct-pay model offers a predictable, transparent alternative to a broken system.

Ultimately, the Amble Cares Program is making a bold bet: that the most efficient way to deliver equitable healthcare to disenfranchised populations isn’t to fix the traditional insurance system, but to innovate entirely around it.

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Natural birth pressure harming new mothers’ mental health, research finds

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Pressure to have a natural birth can cause lasting psychological harm when labour does not go to plan, new research shows.

The study found that the messages women receive during pregnancy are directly linked to the shame and self-blame many feel when those expectations are not met.

For the first time, the research provides an explanation for why unmet birth expectations contribute to psychological harm.

Several women involved in the research said they felt they had not given birth “properly”, even when medical intervention had saved their lives.

Rebecca Matthews, lead author and PhD researcher at the University of Reading, said: “These women were not failed by their bodies, they were failed by the messages they were given.

“Birth trauma does not begin with birth. It begins in the ideology sold to women throughout pregnancy.

“For the first time we can explain precisely how, by showing how birth culture creates a moral standard for women that defines what a good mother does and then leaves them to blame themselves when birth does not match that.

“Until we reform the way we prepare women for birth, we will keep seeing the same devastating consequences for mothers and their babies.”

The researchers interviewed 21 first-time mothers in the UK whose births did not go as planned.

From NCT and hypnobirthing classes, to social media to midwives, the researchers heard how women are surrounded by messaging that frames natural, unmedicated vaginal birth as the “gold standard”, not just medically preferable, but as a mark of being a good mother and the first test of maternal worth.

Research shows around half of women report their birth differed significantly from their expectations, and for the women in this study, all of whom experienced exactly that, the psychological consequences were profound.

Women judged themselves against the internalised moral standard that this ideology had created.

The researchers are calling for antenatal education to stop treating one kind of birth as the goal and to present all birth outcomes as equally valid routes to motherhood.

They also call for better postnatal screening for women whose births did not go as expected, specifically targeting the shame, self-blame and identity disruption that this research identifies as mechanisms underlying birth trauma.

The findings align with and extend the conclusions of the Kirkup, Ockenden and Birth Trauma Inquiry reports, all of which documented how the institutional pursuit of “normal birth” contributed to preventable harm.

This research provides the first theoretical explanation of how that ideology generates individual psychological harm and points to antenatal messaging as the primary site of such preventable harm.

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