News
FDA approves ‘breakthrough’ spiral tampon
The Sequel tampon was approved by the FDA for use as a medical device

The US Food and Drug Administration (FDA) has approved a new design of tampon in a move that could shake up the period care market.
The tampon, developed by California-based start-up Sequel, has diagonal grooves that spiral down the product to allow it to absorb more fluid and offer a more reliable experience.
Developed by athletes and Stanford engineers – Greta Meyer and Amanda Calabrese, the tampon was inspired by the founders’ lived experience in sport.
Its prototype was invented during a class project in 2018 with the aim of raising the standards for women’s period products.
As a part of the FDA clearance process, Sequel performed testing and documentation of the safety and efficacy of the product. It said this validated its confidence in the design of the tampon.
Meyer, co-founder and CEO of Sequel, said: “FDA clearance has been a long process for us, and we know that this is one of the largest barriers to entry for new products in this category.
“However, we understand the importance of these devices being held to the highest standards of safety and quality. We are proud of the work our team has done to reach this milestone for Sequel.”
Claudia Kotchka, Sequel advisor and former vice president of design, innovation and strategy at Procter & Gamble, added: “From the beginning, I’ve been impressed with Sequel’s mission to raise the standard of women’s health and wellness, and with this first product, they’ve brought meaningful innovation to a category ready for change.”
Approval from the FDA marks a critical step in enabling Sequel bring its tampon to market and “reinvigorate” the period care industry.
The company has been granted 11 patents in the US and globally with seven additional patents pending internationally.
The news comes on the heels of significant momentum for the start-up. In December 2021, Sequel secured US$5m in seed funding and opened a new San Francisco headquarters.
Diagnosis
Being female not a universal stroke risk factor for patients with AF, study finds

Female sex may not raise stroke risk across all atrial fibrillation (AF) patients, with higher risk mainly seen in women aged 75 and older, a study suggests.
Researchers said stroke prevention for women with the condition should be more personalised, especially for patients under 75.
Dr Amitabh C Pandey, director of cardiovascular translational research at Tulane University School of Medicine, said: “For years, female sex has been included as a risk factor along with other factors such as high blood pressure and diabetes, meaning women were more likely to be prescribed anticoagulants.
“Our study shows younger women may not have as much added stroke risk as previously thought, while older women, particularly those over 75, appear to have a higher risk that deserves close attention.”
The new Tulane University study challenges a long-standing assumption in heart care that being female automatically increases stroke risk for patients with atrial fibrillation.
Atrial fibrillation, often called AF, is a common heart rhythm disorder that causes the heart to beat irregularly.
It is associated with a higher risk of stroke and is often treated with anticoagulants, also known as blood thinners.
The study found that stroke risk did not increase equally across all female patients with AF.
Instead, researchers said being female may act more as a risk modifier, with increased stroke risk seen primarily among women aged 75 and older or those with a greater burden of other health conditions.
Clinicians often use a scoring system to decide whether people with AF should be prescribed blood thinners.
The system gives points for factors including age, heart failure, diabetes, previous stroke, vascular disease and high blood pressure.
Women also receive one point for sex alone.
Researchers said this can mean women with AF become eligible for blood thinners earlier or more often than men with otherwise similar risk profiles.
While blood thinners can help prevent clot-related strokes, they can also increase the risk of bruising, prolonged bleeding, gastrointestinal bleeding and other serious complications.
The researchers analysed approximately 950,000 patients with AF using TriNetX, a large anonymised electronic health record database.
They compared stroke outcomes between male and female patients across three age groups: younger than 65, 65 to 74, and 75 and older.
Male and female patients were matched based on age, other health problems and whether they had been prescribed anticoagulation medicine.
Among patients younger than 75, the study found no significant difference in one-year stroke risk between men and women.
However, among patients aged 75 and older, women had a modest but statistically significant increase in stroke risk compared with men.
In patients aged 75 and older with no additional risk factors beyond age, women had about one additional stroke per 629 patients compared with their male counterparts.
The findings support growing interest in a newer AF risk score, known as CHA2DS2-VA, which removes sex as a standalone risk factor.
However, researchers said more studies are needed and medical guidance remains inconsistent.
Han Feng, assistant professor at Tulane University School of Medicine, said: “This general approach came from women being underrepresented in AFib trials and studies comprising only about one-third of study populations.
“Our study shows not all women with AFib have the same risk profile, and these decisions should be individualised.
Pandey said: “These findings highlight the need for modern tools and approaches that can personalise risk profiles to individuals.
“The goal is not to undertreat patients who need stroke prevention, but to better identify who is most likely to benefit from anticoagulation and who may be exposed to unnecessary risk.”
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