News
Innovative menstrual cup secures FDA clearance

The US menstrual care brand Sunny has received FDA clearance for its reusable menstrual cup.
Sunny’s innovation, a reusable period cup that comes with a tampon-style applicator, has become the only menstrual cup and applicator to receive FDA 510(k) clearance.
The product is made of medical-grade silicone, as well as other reusable medical-grade materials.
The Class II Medical Device removes the barriers keeping tampon users from switching to a more sustainable period care option that is free of potentially harmful materials.
“I’m incredibly proud of our team that earned this 510k Clearance,” Cindy Belardo, co-founder and CEO of Sunny, told Femtech World.
“We know it’s a major win for female health. I hope that in seeing our journey, we validate the urgency for attention to the femtech space.”
Drew Jarvis, co-founder and CMO of Sunny, who first began innovating in period care after trying a menstrual cup in high school, said: “Menstrual cups have historically been exempt from the 510(k) process due to substantial equivalence.
“Because we invented the very first menstrual cup applicator, we had to reprove that substantial equivalence so, we had to go through the 510(k) process, which speaks to the innovative nature of our device.”
The Sunny Cup + Applicator inserts like a tampon, holds two to five times the amount of tampons and can be used for up to 12 hours at a time.
Since their launch in 2022, Sunny has sold 20,000 units, raised US$2.5m, and secured US$850k in pre-sale orders.
Looking ahead, the next big goal for Sunny is to establish a sustainable manufacturing process to keep up with the demand and orders.
To receive the Femtech World newsletter, sign up here.
Diagnosis
AI may help accelerate breast cancer diagnosis for high-risk women – study
Fertility
Infertility may be risk factor for early menopause, study suggests
News
Endometriosis documentary profiles stars including Marilyn Monroe and Amy Schumer

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.
Menopause1 week agoPerimenopause misinformation ‘putting women at risk’
News4 weeks agoNIH Grant terminations disproportionately impact minority scientists, research finds
Wellness4 weeks agoWUKA brings Period-Positive Pool Party to London Aquatics Centre to keep girls swimming through puberty
Insight3 weeks agoPCOS renamed after decade-long campaign to end ‘cyst’ misconception
Events4 weeks agoWHIS 2026 unveils agenda and first speakers for the leading women’s health summit
Menopause4 weeks agoCBT shows promise for menopause insomnia and hot flashes
Hormonal health2 weeks agoNHS urged to update website following renaming of PCOS
News6 days agoThree menopause innovators shortlisted for Femtech World Award
















1 Comment