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Women have been ‘left out of medical devices’, say experts amid bias concerns

Women, minority ethnic people and those from deprived communities are at risk of poorer healthcare due to biases within medical tools

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Women, people of colour and those from deprived communities have been “left out of medical devices”, experts have said, amid growing bias concerns.

Specialists have told Femtech World that there is currently no equity in medical devices, an issue which can put people at risk and exacerbate existing health inequalities.

Marissa Fayer, medical device expert and CEO of DeepLook Medical, said: “This has long been a problem in the field of medical devices and all areas of healthcare.

“Women, people of colour, people living in non-urban areas and mostly anyone except a white middle-aged man have been left out of medical devices.”

Minority ethnic people, women and people from deprived communities have been found to be at risk of poorer healthcare because of biases within medical tools and devices.

A review advising the UK government on the health impact of potential bias in medical devices, published this week, raised concerns over AI devices and tools that measure oxygen levels.

The Equity in Medical Devices: Independent Review confirmed concerns pulse oximeters overestimate the amount of oxygen in the blood of people with dark skin, noting that while there was no evidence of this affecting care in the NHS, harm has been found in the US with such biases leading to delayed diagnosis and treatment, as well as worse organ function and death, in Black patients.

Annie Thériault, managing partner at Cross-Border Impact Ventures, said this is unsurprising, since bias is pervasive in the medical field.

“The majority of innovations and surgical tools are meant to be used by larger white males and may be more difficult for a smaller person, such as a woman. Similarly, certain medical devices fit larger bodies and there is often no data on whether a smaller version is as effective on a smaller person.”

Dr Chung Looi, CEO of Ablatus Therapeutics, voiced similar concerns.

She said: “Development of medical devices is a long and expensive process. Women, people of diverse backgrounds, biological profiles and communities with limited resources have historically been overlooked and deprioritised.

“Being inclusive in the design, testing and market reach of medical devices is not only ethical, but also a smart investment to reduce the risk of widening health and wealth disparities, and ensure that benefits of technological advancements can be share by all.”

However, Gloria Kolb, co-founder and CEO of Elidah, said: “I don’t necessarily agree that there are biases in medical devices. The devices are just that – devices that take measurements, output signals, used as tools.

“I would suppose that the potential for biases may be more in diagnostics, as the data the diagnostic is based on may not be universally tested across races. Moreover, the biases come into play in how these tools and devices are being used or offered.”

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Diagnosis

AI may help accelerate breast cancer diagnosis for high-risk women – study

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AI may help speed breast cancer diagnosis for high-risk women after abnormal mammograms, a study suggests.

Women with abnormal mammograms often wait weeks to learn whether they have breast cancer.

Researchers at UC San Francisco and UC Berkeley said an AI-guided workflow could help reduce that wait by quickly identifying those most likely to have the disease. Some women could move from imaging to evaluation, and sometimes biopsy, in a single day.

Dr Maggie Chung, first author of the study, said: “This is a really an exciting time.

“This moves us closer to personalised care, where we can tailor a plan so that each patient gets the right intervention at the right time.”

The study used an open-source AI model called Mirai.

The model was trained on hundreds of thousands of mammograms linked to patients’ cancer outcomes.

A mammogram is an X-ray scan of the breast used to look for signs of cancer. A biopsy involves taking a small tissue sample to test for disease.

The AI tool is designed to detect subtle patterns in screening mammograms and predict a woman’s cancer risk.

Researchers at UC San Francisco and UC Berkeley applied the model to more than 4,100 screening mammograms at Zuckerberg San Francisco General Hospital and Trauma Center.

Mirai identified 525 women, about 12.7 per cent of screened patients, as high risk.

Those patients could receive an interpretation of their mammograms immediately after the scan and have additional diagnostic imaging for suspicious areas on the same day.

Some women who needed biopsies were also able to have them on the same day.

The researchers said Mirai reduced the wait time for diagnostic evaluation from several weeks to about an hour.

For women who were ultimately diagnosed with breast cancer, it reduced the average wait for biopsy from more than two months to fewer than 10 days.

The researchers stressed that Mirai does not replace radiologists or make diagnoses on its own.

Instead, it acts as a triage tool to help physicians identify the patients who can benefit most from accelerated care.

The team analysed more than 114,000 archival mammograms before launching the programme, to ensure the model would capture enough high-risk patients without overloading the clinic with too many expedited evaluations.

The researchers said they hope AI will support a more personalised approach to breast cancer screening tailored to each patient’s breast cancer risk.

Chung said: “Right now, many women follow the same screening schedule but their individual risk can be very different.

“AI risk assessment gives us the chance to identify the women most likely to benefit from expedited care and get them what they need.”

Adam Yala, senior author of the study and a data scientist at UC Berkeley, said: “This is a powerful example of how AI can be a collaborative partner for physicians.

“It shows how we can improve care when we bring clinicians and data scientists together to design these systems.”

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Fertility

Infertility may be risk factor for early menopause, study suggests

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Women with primary infertility may face a higher risk of early menopause and reach it about a year earlier, a study suggests.

The findings suggest women with primary infertility may be more likely to enter menopause before the age of 45.

The increased risk appeared most notable among women with unexplained infertility or a history of endometriosis.

Dr Stephanie Faubion, medical director for The Menopause Society, said: “This study shows that women with primary infertility, specifically those with unexplained infertility or a history of endometriosis, were at risk for early menopause.

“Given that early menopause is linked to adverse long-term health consequences, these women may benefit from counselling that they are at risk of early menopause.

“This will allow them to monitor for early menopause and to seek treatment with hormone therapy, if indicated.”

Early menopause is usually defined as menopause before age 45, while premature menopause is menopause before age 40.

Women who experience menopause earlier may face symptoms for longer and have a higher risk of long-term health problems.

These can include cardiovascular disease, osteoporosis and neurocognitive disorders. Osteoporosis weakens bones, while neurocognitive disorders affect memory, thinking or brain function.

The study, highlighted by The Menopause Society, involved nearly 700 people, roughly half of whom had been diagnosed with primary infertility.

It found that women with a history of primary infertility underwent natural menopause about one year earlier than those without such a history.

Researchers found no association between infertility and premature menopause.

Infertility affects around one in six people globally and can have consequences beyond family planning.

Previous research has linked infertility with higher rates of cancer and cardiovascular disease, although causes vary and may involve genetic, hormonal, in-utero or lifestyle factors.

In-utero factors are influences that occur while a baby is developing in the womb.

Earlier studies looking at links between infertility and early or premature menopause have produced mixed results, with some not accounting for different types of infertility.

The new study suggested that women with unexplained infertility or a history of endometriosis may have an increased risk of early menopause.

Endometriosis is a condition where tissue similar to the lining of the womb grows elsewhere in the body. It can cause pain, heavy periods and fertility problems.

Known risk factors for early or premature menopause include tobacco use, low body mass index, not having given birth and starting periods at a younger age.

Women who have had more childbirths and those with a history of oral contraceptive use have previously been linked to later menopause.

The researchers said women with primary infertility may benefit from additional counselling because of the systemic and long-term health effects of early menopause.

They also said women should be encouraged to seek evaluation and treatment if they experience a new loss of menstrual cycles.

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News

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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