News
FDA approves menstrual blood diagnostic device in Thailand
The developers say the device could provide an alternative diagnostic test to the Pap smear

The US biotech company Qvin has announced FDA approval in Thailand for its menstrual blood diagnostic device.
Qvin has developed its Q-Pad technology to provide women with accessible and “non-invasive” diagnostic testing for prevention and early detection.
The company aims to eliminates common barriers to traditional laboratory testing, which can be difficult due to lack of access to care, cultural shame, religious beliefs or financial means.
Thailand, where the device was recently approved, has a population of 30 million women ages 15 years and older who are at risk of developing cervical cancer.
However, the FDA approval is hoped to allow thousands of women to have access to menstrual blood testing and test for HR-HPV.
Q-Pad, a menstrual pad used twice during menstruation, includes a removable cotton strip which is sent to a laboratory for clinical testing. Users are then sent their lab report results through an app or through their healthcare provider.
According to the developers, the device will provide an alternative diagnostic test to the Pap smear, providing an accessible and non-invasive way to screen for HR-HPV.
“As part of our efforts to help women in Thailand prevent cervical cancer, we believe Qvin’s Q-Pad is one of the most innovative ways to screen for HR-HPV earlier,” said Dr Chairat Panthuraamphorn, managing director and CEO at Samitivej Hospital.
“We believe this is a progressive, modern-day approach to cervical cancer prevention and an excellent alternative to Pap smears in our hospital system.”
Dr Sara Naseri, Qvin CEO and co-founder, said: “Receiving FDA approval in Thailand is exciting and contributes to our vision of a world where women do not die from cancers, like cervical cancer, that are entirely preventable if caught early.”
“Approval not only marks a milestone on our journey to move the study of women forward, but it means we can provide accessible testing to millions of people in Thailand to identify HR-HPV earlier to try and eliminate cervical cancer there and look for more countries to follow.”
Dr Paul D. Blumenthal, Professor of obstetrics and gynaecology at Stanford University, said: “It is well known that regular HPV screenings save lives by leading to detection of cervical pre-cancer, which enables patients and providers to treat it effectively before it turns into cervical cancer, a leading cause of death for women globally.
“I’m thrilled that the Q-Pad has been cleared in Thailand, which has high cervical cancer rates.
“Access to testing means users will be able to take control of their health easily and efficiently.”
The FDA Thailand regulatory clearance was completed in collaboration between Qvin, N Health Laboratories and Bangkok Health Research Center (BHRC).
In addition to regulatory clearance, Bangkok Health Research Center plans to conduct a 1,500-person comparative study on HR-HPV using both Q-Pads and Pap smears.
The data collected will be used to further understand the prevalence of HPV and cervical cancer in Thailand and develop strategies to screen for HR-HPV sooner and save lives.
Insight
From Hologic to Ark Surgical: Why Joseph LaBruzzo is betting on the future of women’s surgical innovation

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.
Pregnancy
Pregnancy complications may increase risk for artery disease, study finds

Pregnancy complications may increase women’s risk of peripheral artery disease later in life, new research suggests.
The study analysed data from more than two million women in Sweden who gave birth to single babies between 1973 and 2015.
Led by Casey Crump, the research examined the long-term risk of peripheral artery disease among women who experienced preterm delivery, pre-eclampsia, gestational diabetes or other adverse pregnancy outcomes.
Crump, professor in the department of family and community medicine at McGovern Medical School at UTHealth Houston, said: “Our prior work has already shown that adverse pregnancy outcomes are associated with long-term risks of heart disease, stroke, and heart failure.
“This study builds on that work by showing that these women have an increased risk of peripheral artery disease, an important but understudied cardiovascular condition.”
Peripheral artery disease is often a precursor to long-term cardiovascular complications, including stroke, ischaemic heart disease and premature death.
The condition affects millions of people worldwide and occurs when narrowed arteries reduce blood flow, most commonly to the legs and feet.
Ischaemic heart disease occurs when the heart does not receive enough blood and oxygen, usually because the arteries have narrowed.
Symptoms of peripheral artery disease can include leg pain, cramps while walking, numbness, cold feet and sores on the feet or legs that are slow to heal.
Crump said women who experience pregnancy complications have an important opportunity after giving birth to make plans with their primary care doctor to monitor long-term risks.
Women who have experienced complicated pregnancies should speak with their doctor about possible future cardiovascular health risks.
Checks for blood pressure, diabetes and cholesterol are important.
While the period after childbirth is an important time for women to monitor their health, Crump said it is never too late to lower the risk of peripheral artery disease.
He said: “Women with a history of adverse pregnancy outcomes who seem to be doing well may still have a higher risk that can emerge later in life.”
Crump also suggested preventive steps such as avoiding smoking, maintaining a healthy weight and following a healthy lifestyle.
He stressed the importance of long-term follow-up care and conversations with healthcare providers to help protect cardiovascular health later in life.
Hormonal health
PMOS could increase heart disease risk, study finds

Women with PMOS may have a fourfold higher risk of heart disease, new research suggests.
PMOS, or polyendocrine metabolic ovarian syndrome, is a complex hormone condition affecting about one in eight women in the UK.
It can affect hair growth, periods, fertility and mood.
US researchers analysed health insurance data collected between 2000 and 2022 from 413,450 women with PMOS aged 18 to 50.
They compared the group with more than two million women who did not have the condition.
The study found that women with PMOS had a fourfold higher risk of heart disease than those without it.
The increased risk remained after researchers accounted for other factors linked to heart disease, including high blood pressure and diabetes.
International PMOS guidelines recommend screening all patients for heart disease risk at diagnosis and providing advice on lifestyle changes.
However, researchers said patient surveys “report delayed diagnosis and substantial dissatisfaction with counselling regarding long-term comorbidities”.
Comorbidities are additional health conditions that occur alongside a main condition.
Researchers added: “Our results emphasise the need for physician education and patient awareness of cardiovascular disease risk to improve implementation of early preventive interventions.”
The team called for further studies following women through menopause, when periods stop.
They also called for research into whether treatments such as GLP-1 drugs or hormonal contraception affect the link between PMOS and heart disease.
GLP-1 drugs are medicines used for conditions including type 2 diabetes and weight management.
The main symptoms of PMOS include irregular periods or long gaps between periods, excessive hair growth or hair loss, weight gain or difficulty losing weight, and difficulty becoming pregnant.
Other symptoms include depression or anxiety, oily skin and acne, tiredness, and thick, dark patches of skin on the neck or armpits, known as acanthosis nigricans.
Until recently, PMOS was known as polycystic ovarian syndrome, or PCOS.
Experts called for the name change after highlighting that misunderstandings about cysts and too much focus on the ovaries were delaying diagnoses.
Earlier this month, the National Institute for Health and Care Excellence said women with PMOS should be seen by health professionals annually to monitor symptoms and manage long-term risks.
NICE said the condition affects between three and four million women in the UK but is “frequently underdiagnosed and inconsistently managed”.
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