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Smart baby monitoring device receives FDA clearance

The device provides a real-time display of the baby’s heart rate and oxygen saturation level

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A smart baby monitoring device that uses pulse oximetry technology to provide medical-grade infant monitoring has received clearance from the US Food and Drug Administration (FDA).

BabySat, the first medical pulse oximetry sock for infants aims to help parents monitor their babies at home, while under the supervision of a physician.

Available through prescription, the device, developed by the US company Owlet, uses pulse oximetry technology to provide a real-time display of the baby’s heart rate and oxygen saturation level (SpO2) and alerts parents when these readings fall outside of prescribed ranges.

This would in turn enable caregivers to feel confident in providing at-home care and help reduce the strain on medical resources, the developer says.

Innovation in the baby care space matters because some of the largest issues facing caregivers and healthcare providers have yet to be solved.

There are roughly 92 million infant care visits covering a child’s first four years of life, significantly straining the availability of hospital beds and quality of care.

“Our mission is to provide caregivers with the right information at the right time to make informed decisions about their baby’s health,” said Kurt Workman, Owlet co-founder and CEO.

“Today, parents whose babies need additional monitoring are sent home with traditional solutions that can be restrictive and more cumbersome for parents.

“BabySat pushes forward the modernisation of hospital-grade technology for at-home use, and underscores our commitment to transforming baby care solutions.”

In 2021, Owlet pulled its Smart Sock from the market after the FDA issued a warning letter condemning the unregulated device’s use in alerting parents when their babies’ heart rates or blood oxygen levels left predetermined healthy ranges.

Owlet had warned customers that its monitoring system was a consumer product and was not designed to “diagnose, cure, treat, alleviate or prevent any disease or health condition or investigate, replace or modify anatomy or any physiological process,” but the FDA suggested that the alerts could still lead parents and healthcare providers to infer that a baby was experiencing desaturation or bradycardia, and so the devices had to be reviewed by the regulator.

Now, BabySat, the new version of the product, has earned the agency’s clearance.

The device will be available in the US later this year.

Hormonal health

Type 2 diabetes rising among young women, experts warn

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Type 2 diabetes is rising among women in their 20s in England, with experts warning of a worrying increase since the Covid pandemic.

The rise has largely occurred since the pandemic and is closely linked to increasing obesity levels, according to an analysis of NHS data from 2011 to 2024.

The condition is serious and can lead to severe complications, including heart attacks and strokes.

Diabetes UK said it tends to be more aggressive when it develops at a younger age, raising the risk of serious complications and shorter lives.

The charity said early diagnosis is vital for people at risk to help prevent long-term organ damage.

The condition can sometimes be put into remission through healthy eating and maintaining a healthy weight, without relying on glucose-lowering medicines.

Researchers said newer obesity treatments, including GLP-1 injections and pills, may also help alongside healthy eating advice.

About 90 per cent of the six million people living with diabetes in the UK have type 2 rather than type 1, or insulin-dependent, diabetes.

The risk increases with age, and older adults still account for the largest proportion of new diagnoses.

However, NHS England estimates suggest that 12,000 people under 30 are now living with the condition, with women making up more of the younger cases.

Common symptoms include feeling very tired, urinating more often than usual and feeling thirsty all the time.

Researchers at Imperial College London analysed NHS data from the English National Diabetes Audit to examine trends over time.

The figures showed that cases are falling slightly among older adults, who still account for the largest share of new diagnoses.

However, diagnoses are increasing rapidly among people under 40, with some of the sharpest rises among women aged 20 to 29.

Body mass index at diagnosis has also been rising more quickly among younger adults than in older age groups, pointing to obesity as a likely factor.

Body mass index, or BMI, is a measure of obesity based on a person’s height and weight.

Separate NHS data for England shows obesity rates have worsened since the pandemic, with nearly one in three people now affected.

The largest increases over time have been among younger adults.

Between 2019 and 2025, new obesity cases rose by 16 per cent among people aged 20 to 29 and by almost 20 per cent among those aged 30 to 39.

Rates fell among adults aged 60 to 79 over the same period.

Lead researcher Dr Shivani Misra said: “We think that the earlier onset of severe obesity in young people is increasing their type 2 diabetes risk in early life and pulling down their age at diagnosis.

“This is really worrying given the poor health outcomes from early-onset type 2 diabetes.”

Misra said much of the discussion about rising rates among younger people had focused on ethnic minority groups, which have traditionally been considered at higher risk.

However, the new data suggests the trend extends well beyond those communities.

She added: “We now see that incidence is also increasing in white populations too, showing that this public health challenge is broadening across the generations.”

Diabetes UK said better follow-up care is also needed for mums-to-be diagnosed with gestational diabetes during pregnancy because it raises the risk of developing type 2 diabetes after childbirth.

Some studies have suggested that the risk of developing the condition may also increase after being ill with Covid, although the evidence remains inconclusive.

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Wellness

AstraZeneca drug approved for breast cancer in EU

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AstraZeneca’s breast cancer drug Etcamah has been approved in the EU as part of a combination treatment for advanced disease.

The European Commission acted on a positive opinion from the Committee for Medicinal Products for Human Use, the Cambridge, England-based drug maker said.

The decision followed positive results from the Serena-6 phase III trial, which showed a 56 per cent reduction in the risk of disease progression in advanced oestrogen receptor-positive breast cancer.

A phase III trial is a large, late-stage study used to assess a treatment’s safety and effectiveness before wider regulatory approval.

Oestrogen receptor-positive breast cancer is a form of the disease that can grow in response to the hormone oestrogen.

Etcamah, whose generic name is camizestrant, was tested in combination with a cyclin-dependent kinase 4/6 inhibitor.

Known as CDK4/6 inhibitors, these medicines block proteins that help cancer cells grow and divide.

AstraZeneca said the Etcamah combination has also been approved in Japan, the UAE and Saudi Arabia based on the Serena-6 trial results.

The company said breast cancer remains the leading cause of cancer death among women in Europe, with more than 140,000 deaths and more than 540,000 patients diagnosed in 2024.

AstraZeneca shares were down 0.6 per cent at 12,628 pence in London on Thursday.

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Entrepreneur

From Hologic to Ark Surgical: Why Joseph LaBruzzo is betting on the future of women’s surgical innovation

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After more than two decades leading organisations at some of the world’s most respected medical device companies, including Hologic, SenoRx Breast Care, and BTL Industries, Joseph B. LaBruzzo is embarking on a new chapter as President & CEO of U.S. Operations and Board Member at Ark Surgical.

We sat down with Joseph to discuss what drew him to Ark Surgical, why he believes women’s surgical innovation is entering a transformative era, and what it takes to bring meaningful technologies from concept to standard of care.

You have held leadership positions at some of the biggest names in MedTech. What attracted you to Ark Surgical?

Throughout my career, I’ve been fortunate to work with organisations that developed technologies capable of changing the standard of care.

What attracted me to Ark Surgical is the opportunity to help address a meaningful unmet need in gynecologic surgery with an innovation that has the potential to improve patient outcomes while preserving the benefits of minimally invasive surgery.

Opportunities like that don’t come along very often.

FemTech World recently highlighted that many women remain unaware of gynecologic cancers and that unexpected diagnoses continue to have a profound impact on patients and families.

How has your own experience shaped the way you think about innovation in women’s health?

Earlier in my career, I witnessed many women receive life-changing cancer diagnoses.

Those experiences stayed with me and reinforced my belief that if there’s an opportunity to reduce risk through better innovation, it’s one worth pursuing.

That’s one of the reasons I was drawn to Ark Surgical.

The vast majority of minimally invasive gynecologic procedures are performed for conditions believed to be benign. Unfortunately, in rare cases, pathology later reveals an unexpected malignancy.

LapBox was designed with a proprietary dual-wall tissue containment system to help facilitate contained specimen retrieval and minimise the risk of tissue spillage during laparoscopic procedures.

I believe innovations like this can help surgeons manage the unexpected while preserving the many benefits of minimally invasive surgery for women.

Women’s health has gained significant momentum in recent years, yet surgical innovation often receives less attention than diagnostics or therapeutics. Why do you think that is?

Women’s health has historically been underfunded and underserved across many areas of medicine, and surgery is no exception.

While we’ve seen tremendous advances in diagnostics and pharmaceuticals, there are still important opportunities to improve the surgical experience for both physicians and patients.

Innovation that enhances safety, efficiency, and outcomes has the potential to make a lasting impact.

What excites you most about LapBox?

LapBox addresses a very real challenge that gynecologic surgeons face during minimally invasive procedures.

It was thoughtfully designed to integrate seamlessly into the surgical workflow while providing an added layer of confidence when tissue retrieval is required.

I believe technologies that solve real clinical challenges in a practical way have the greatest potential to become part of the standard of care.

What do you see as the biggest unmet needs in minimally invasive gynecologic surgery today?

The future of surgery isn’t simply about making procedures less invasive. It’s about making them smarter and safer.

Surgeons need technologies that integrate seamlessly into their workflow while helping them navigate increasingly complex clinical situations.

Every advancement that helps reduce risk while preserving the benefits of minimally invasive surgery has the potential to improve outcomes for both physicians and patients.

That’s where I believe the greatest opportunities for innovation exist.

As you take on this new role, what are your priorities over the next 12 months?

Our focus over the next 12 months is to build a strong foundation for growth. That means expanding physician partnerships, driving early clinical adoption, growing our team, and ensuring that more surgeons have access to technologies like LapBox.

At the same time, we’re focused on building strategic relationships with investors, healthcare systems, and industry partners that support our long-term vision.

What advice would you give entrepreneurs building the next generation of women’s health companies?

Start with a real clinical problem and never lose sight of the patient.

Great technology alone isn’t enough. You also need strong clinical evidence, physician advocates, and a clear market strategy. The companies that succeed are the ones that bring all of those pieces together while remaining focused on improving patient care.

About Joseph B. LaBruzzo

As President & CEO of U.S. Operations and Board Member, Joseph LaBruzzo is leading Ark Surgical’s U.S. growth strategy, physician partnerships, strategic investment initiatives, and organisational expansion, supporting the company’s mission to advance safer minimally invasive gynecologic surgery through innovative technologies.

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