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UK government to tackle ethnic and other biases in medical devices

Significant action is being taken to overcome potential disparities in the performance of medical devices, ministers have said

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The UK government has announced action to tackle potential bias in the design and use of medical devices after an independent review raised concerns over AI devices and pulse oximeters used in the NHS.

The Department of Health and Social Care commissioned senior health experts to identify potential biases in these devices and recommend how to tackle them.

The government said it fully accepted the report’s conclusions and made a series of commitments, including making sure that pulse oximeter devices used in the NHS can be used safely across a range of skin tones, and removing racial bias from data sets used in clinical studies.

Minister of State, Andrew Stephenson, said: “I am hugely grateful to Professor Dame Margaret Whitehead for carrying out this important review.

“Making sure the healthcare system works for everyone, regardless of ethnicity, is paramount to our values as a nation. It supports our wider work to create a fairer and simpler NHS.”

Ministers agreed that unless appropriate action is taken, ethnic and other unfair biases can occur throughout the medical device life cycle, from research, development and testing, to approval, deployment and post-market monitoring, as well as in the use of devices once deployed.

They said “significant action” is already being taken to overcome potential disparities in the performance of medical devices. This includes:

  • the Medicines and Healthcare products Regulatory Agency (MHRA) now requests that approval applications for new medical devices describe how they will address bias
  • NHS guidance has been updated to highlight potential limitations of pulse oximeter devices on patients with darker skin tone
  • the National Institute for Health and Care Research (NIHR) is currently accepting funding applications for research into smarter oximeters

The government appointed Professor Dame Margaret Whitehead, professor of public health at the University of Liverpool, to lead the review.

The review followed concerns that pulse oximeters – widely used during the pandemic to monitor blood oxygen levels – were not as accurate for patients with darker skin tones, which could have led to delays in treatment if dangerously low oxygen levels in patients with darker skin tone were missed.

However, it found no evidence from studies in the NHS of this differential performance affecting care.

The medical devices review focused on three areas – optical devices such as pulse oximeters, AI-enabled devices and polygenic risk scores (PRS) in genomics.

Professor Dame Margaret Whitehead, chair of the review, said: “The advance of AI in medical devices could bring great benefits, but it could also bring harm through inherent bias against certain groups in the population, notably women, people from ethnic minorities and disadvantaged socio-economic groups.

“Our review reveals how existing biases and injustices in society can unwittingly be incorporated at every stage of the lifecycle of AI-enabled medical devices, and then magnified in algorithm development and machine learning.

“Our recommendations therefore call for system-wide action, requiring full government support. The UK would take the lead internationally if it incorporated equity in AI-enabled medical devices into its global AI safety initiatives.”

The review, Whitehead said, also recommended ways of developing “bias-free” medical devices in the future and to improve standards globally.

Dr June Raine, MHRA chief executive, said: “MHRA acknowledges that inequities can exist within medical devices and we therefore welcome the publication of Dame Whitehead’s independent review.

“We are highly committed to ensuring equitable access to safe, effective and high-quality medical devices for all individuals, and the recommendations set out in this report will support and strengthen the impact of our ongoing work in this area.

“We are committed to working collaboratively with government, regulatory bodies, healthcare professionals and stakeholders to address these issues effectively.

Professor Bola Owolabi, NHS England’s director of healthcare inequalities, added: “Ensuring all patients get equitable access to high-quality healthcare remains crucial to reducing health inequalities and a priority for the NHS.

“I welcome the report’s findings and the NHS will work alongside government and MHRA to implement them and ensure NHS staff have the resources and training they need to tackle racial bias.”

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Canadian insurer launches partnership to support women’s health

Members of the Canadian insurer Medavie Blue Cross will have access to a dedicated women’s health platform

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Angela Johnson, co-founder and CEO of sanoLiving

The Canadian insurer Medavie Blue Cross (MBC) has partnered with the virtual health platform sanoLiving to support women on their menopause journey.

Currently, more than 10 million Canadian women are navigating menopause, often with little support and misinformation about treatments.

With sanoMidLife, sanoLiving’s online menopause platform, Medavie Blue Cross members will have access to a national women’s health platform tailored to provide care and services for women going through the menopause.

The service includes personalised assessments, access to clinicians, treatments, educational content, peer support and AI assistance.

“Many women lack support for their menopause transition due to the misunderstandings of what is ‘normal’ and misinformation about treatments,” said Angela Johnson, co-founder and CEO of sanoLiving.

“Women are seeking solutions that allow them to thrive during midlife. We are thrilled about our alliance with Medavie Blue Cross, and our shared commitment to providing access to care that empowers women.”

Anita Swamy, senior vice president operations at Medavie Blue Cross, added: “We’ve heard first-hand from our members about the need for more menopause-related services.

“Our partnership with sanoLiving creates an innovative way to increase access to care for our members as we continue to focus on the support women need to navigate their benefits and provide forward-thinking options to support their health.”

Studies report one in 10 women exit the workforce due to unmanaged symptoms. Early onset of menopause and symptoms before age 45 can elevate the risk of health issues like heart disease, diabetes, dementia and osteoporosis.

With this new service, Medavie Blue Cross and sanoLiving are aiming to open up the conversation around menopause, reduce stigma and work towards giving women the access to the care they need.

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US start-up raises US$2.32m to address pelvic health concerns

The Flyte intravaginal device aims to treat stress urinary incontinence and strengthen pelvic floor muscles

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The US women’s health start-up Pelvital has raised US$2.32m in funding to address “unanswered” pelvic health issues.

Minnesota-based Pelvital aims to restore pelvic health with its first product Flyte, an FDA-cleared intravaginal treatment for stress urinary incontinence (SUI) and weakened pelvic floor muscles.

The device, originally developed by physicians from the Arctic University of Norway, uses mechanotherapy, a treatment modality that when paired with an active pelvic floor contraction stimulates tissue regeneration and the creation of neuromuscular memory.

The company will use the funding to speed up the commercialisation of Flyte and raise awareness of pelvic health issues.

“Completing this round is an important step in continuing Pelvital’s unwavering dedication to provide women with innovative solutions for pelvic health, including the treatment of SUI,” said Lydia Zeller, president and CEO of Pelvital.

“This funding will play a crucial role in accelerating our commercialisation of Flyte with a strong emphasis on expanding payor coverage and enhancing clinical education and clinician awareness.”

With this final close, Zeller said, Pelvital would welcome new investors including Pier 70 Ventures, Life Science Angels, Tech Coast Angels Orange County, and Blue Pacific Fund.

Preetha Ram, managing partner at Pier 70 Ventures, would join the Pelvital board of directors.

“Joining Pelvital’s board alongside this investment round is truly an honour,” Ram shared.

“Pier 70 and I are thrilled to be part of this transformational opportunity, as Pelvital’s mission aligns beautifully with our dedication to support disruptive technologies that shake up the status quo in healthcare.

“Pelvital’s pioneering work is shaping a future where women’s health receives the attention and innovation it deserves with novel medical devices like Flyte.”

Oscar Moralez, founder and managing partner of Boomerang Ventures who led the investment round, said: “We are thrilled for the successful completion of this round as we aim to tackle the most pressing healthcare challenges.

“Our participation aims to address the chronic underfunding in women’s healthcare. Investing in Flyte, a truly groundbreaking treatment, addresses underserved pelvic health issues like SUI and contributes to raising vital awareness.”

Two published clinical trials have validated Flyte’s safety, efficacy and durability of treatment effect for women with SUI.

Most recently Pelvital published a paper in Therapeutic Advances in Urology, showing that 71 per cent of study participants achieved dry or near dry conditions as evidenced by a reduction in 24-hour pad weight after using Flyte for between two and 12 weeks.

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Cleveland Clinic launches new women’s health and research center

The programme aims to address women’s unique health needs during midlife and beyond

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From left: Cleveland Clinic CEO and president Dr Tom Mihaljevic, Maria Shriver and Dr Beri Ridgeway / Source: clevelandclinic.org

Cleveland Clinic has launched its new Women’s Comprehensive Health and Research Center, an initiative dedicated to helping women during midlife.

The center, which will focus on access, connectivity, education and research and innovation, aims to empower women to navigate their health journey with confidence and clarity.

Maria Shriver, founder of The Women’s Alzheimer’s Movement Prevention and Research Center at Cleveland Clinic, will serve as chief visionary and strategic advisor.

“I’ve always believed our nation needed a first-class comprehensive women’s health center, and now we have one,” said Shriver.

“Over the past several years, I’ve been honoured to work alongside so many talented and passionate doctors at Cleveland Clinic to bring this vision to life. This is a place for women at every stage of life where they will feel seen, will get the research they need, and the care they deserve, from their brains to their bones.

“I am thrilled that today the WAM Prevention and Research Center expands, as it deserves to.”

Dr Tom Mihaljevic, Cleveland Clinic CEO and president, said: “Maria’s unwavering commitment to raising awareness and driving meaningful change aligns perfectly with the mission of our new center.

“Her passion for advancing the quality of care for women is remarkable and will help us transform how we deliver care for women today and into the future.”

The population of women in midlife and in need of healthcare continues to grow. According to US Census Bureau 2020 data, more than 63 million women in the US are 50 years of age or older, and approximately 6,000 women enter menopause each day.

In addition, the Centers for Disease Control and Prevention reports 80 per cent of women aged 55 and older have at least one chronic condition, such as arthritis, asthma, cancer, cardiovascular disease, chronic obstructive pulmonary disease and diabetes, which strengthens the need for more comprehensive medical care for women in this stage of life.

The new Women’s Comprehensive Health and Research Center will bring together specialty care in various areas, including behavioural health, breast health, cardiovascular care, center for infant and maternal health, endocrinology, menopause, osteoporosis and metabolic bone density, wellness and disease prevention.

Through initiatives focused on streamlining appointment processes, enhancing outreach programmes and prioritising health equity, the center will seek to ensure that all women can readily access the care they need.

“Midlife is an important milestone and a time to empower women to address health issues and focus on future health,” said Dr Beri Ridgeway, chief of staff at Cleveland Clinic.

“Taking a holistic approach, including menopausal and hormonal health, reproductive health, mental health, chronic conditions and preventive care, is critical to optimise health outcomes.

“Our priority is to help women in this stage of life make educated decisions about their health and have access to the services they need to thrive, while also feeling seen, heard and supported.”

The center, Ridgeway said, will offer support groups and resources to help address health disparities, reach diverse communities and bridge gaps in health literacy.

The institution’s ultimate mission, she explained, is to advance research and innovation specific to women during midlife.

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