Connect with us

News

Ark Surgical secures FDA clearance for LapBox POWER

Published

on

Ark Surgical, a women’s health-focused medical device company, has received FDA 510(k) clearance for LapBox POWER, a breakthrough tissue containment system (TCS) for use with power morcellators in minimally invasive gynecologic surgery.

This expanded indication builds on the company’s 2023 clearance for manual morcellation, making LapBox the first and only FDA-cleared dual-wall containment system for both manual and power tissue extraction.

Designed in collaboration with leading OB/GYNs, LapBox features an intuitive “bag-in-a-bag” structure that provides a spill-proof barrier – helping to prevent the spread of undiagnosed cancer, endometrial cells, and other potentially harmful tissues during laparoscopic procedures.

The TCS system integrates seamlessly into surgical workflows without adding complexity or time.

Stav Tori is CEO of Ark Surgical.

Tori said: “This new clearance validates what surgeons have already come to appreciate about LapBox – a reliable, intuitive system that raises the bar for safety without complicating the procedure.

“We are proud to deliver the only tissue containment solution cleared for both manual and power morcellation.”

Morcellation is a widely used technique in gynecologic surgery to remove large tissue masses like fibroids or the uterus through small incisions.

Yet uncontained morcellation carries risks, including spreading undiagnosed malignancies or endometrial cells that may worsen conditions like endometriosis or chronic pelvic pain.

In response, the FDA issued multiple safety communications beginning in 2014 and has since urged surgeons to use FDA-cleared containment systems.

With over 2.5 million gynecologic procedures performed annually worldwide and the laparoscopic GYN market projected to reach $61 billion by 2034, the need for effective, surgeon-friendly solutions has never been greater.

LapBox aims to tackle the problem, supporting safer, smarter surgeries that benefit both patients and providers.

News

Femtech World Awards 2026: Winners revealed

Published

on

We are excited to reveal the winners of the third annual Femtech World Awards.

The winners were announced at a virtual event this afternoon attended by shortlisted companies, along with sponsors and judges.

The event welcomed guests from the UK, Europe, Asia, Africa and North America.

Thank you to all 174 entries, as well as the sponsors for making the event possible.

See you in 2027!

Femtech World Awards 2026 Winners

Winner:

Shortlisted:

IVI RMA x Juno Genetics

Natural Cycles

Winner:

Highly commended:

U-Ploid

Shortlisted:

Hello Inside

Winner:

WISE HF, led by Prof. Mary Ryder

Highly commended:

Cardiac College for Women

Shortlisted:

Hyvelle Ferguson-Davis

CognitiveCare

Winner:

Highly commended:

Youterus

Shortlisted:

ŌURA

Winner:

Shortlisted:

LeanShield by ParrotPal Group

Perigen

Winner:

Shortlisted:

Body Moody

Looop

Winner:

Shortlisted:

Owning Your Menopause

Womeno

Winner:

Shortlisted:

The Blue Box

Celbrea

Winner:

Shortlisted:

HealCycle

Mor

Winner:

Shortlisted:

HRC Fertility

Mira

Continue Reading

Motherhood

Expectations about sleep affect postpartum sleep quality, study finds

Published

on

Pregnant women’s expectations about postpartum sleep may predict sleep quality after birth, outweighing prior sleep and psychiatric history, a study suggests.

The findings suggest attitudes and beliefs about sleep during pregnancy could be a modifiable risk factor for postpartum sleep concerns.

They also indicate that, among women expecting the poorest sleep, higher postpartum anxiety may further worsen sleep quality.

Sammy Dhaliwal, lead author is clinical health psychologist and research fellow in the department of obstetrics and gynaecology at the Perelman School of Medicine at the University of Pennsylvania.

Dhaliwal said: “Most pregnant women in our sample anticipated poor postpartum sleep before it occurred, and it was striking that those expectations predicted worse sleep outcomes even after accounting for factors such as prior sleep disorders, psychiatric history, and number of previous births.

“This suggests that attitudes and beliefs about sleep during pregnancy may represent a modifiable target for early intervention before postpartum sleep problems emerge.”

Sleep disturbance affects an estimated 60 to 80 per cent of postpartum women and is linked to a higher risk of depression and anxiety.

Researchers said it is often regarded as an expected part of life after childbirth rather than a health issue that may be addressed earlier.

The study enrolled 432 pregnant women at about 24 weeks of gestation, meaning around 24 weeks into pregnancy.

Participants completed measures of their expectations about postpartum sleep, current sleep quality using the Pittsburgh Sleep Quality Index, and mood using validated depression and anxiety scales.

Assessments were repeated at six, 12 and 24 weeks postpartum.

A subset of 49 women also wore wrist actigraphy devices at six to eight weeks postpartum.

Actigraphy uses a wearable device, similar to a watch, to estimate sleep and wake patterns based on movement.

The results showed that 70 per cent of pregnant women, or 301 of 432 participants, expected poor sleep in the postpartum period.

Researchers found that predicted sleep disruption during pregnancy was a significant predictor of postpartum sleep concerns.

Among first-time pregnant women without prior health concerns, those who expected greater sleep disturbance had significantly more disrupted sleep after birth, measured by both actigraphy and self-report.

Among women who expected the worst sleep quality, higher postpartum anxiety significantly worsened both measured sleep and self-reported sleep, independent of anxiety levels during pregnancy.

Dhaliwal said the findings point to two possible areas for intervention: addressing sleep-related beliefs during pregnancy and treating postpartum anxiety.

Dhaliwal said: “Postpartum sleep disruption is often treated only after problems develop, but our findings suggest there may be an opportunity to intervene earlier during pregnancy.

“Addressing sleep-related beliefs and postpartum anxiety during prenatal and postpartum care may help improve sleep and emotional well-being in new mothers.”

Continue Reading

Fertility

Weight loss jab shows early promise in improving PMOS fertility

Published

on

A weight loss jab may improve fertility outcomes in women with PMOS, early findings from an ongoing clinical trial suggest.

The proof-of-concept analysis found that injectable semaglutide may offer reproductive benefits while also addressing obesity and metabolic dysfunction.

It is the first report to examine how injectable semaglutide may improve reproductive outcomes in women with PMOS while also addressing obesity and metabolic dysfunction.

The work forms part of the ongoing RESTORE clinical trial.

Melanie Cree, professor at CU Anschutz and first author of the report, said: “Women with PMOS frequently face a frustrating choice between treatments that target reproductive symptoms and those that address metabolic health.

“Our early findings suggest injectable semaglutide may have the potential to improve both, offering a more comprehensive approach to care.

“This medication is incredibly promising when someone responds with 10 per cent weight loss.”

The trial is examining whether semaglutide can restore ovulation and improve reproductive health in adolescents and adults with polyendocrine metabolic ovarian syndrome, known as PMOS.

PMOS, formerly known as polycystic ovary syndrome or PCOS, is a hormone and metabolic condition linked to irregular periods, raised testosterone levels, infertility risk, obesity and increased cardiometabolic disease.

Cardiometabolic disease refers to conditions linked to the heart and metabolism, such as heart disease, high blood pressure and type 2 diabetes.

Existing treatments, including metformin and hormonal contraceptives, often do not fully address reproductive and metabolic complications at the same time.

The analysis focused on participants aged 12 to 35 who lost at least 10 per cent of their body weight during treatment.

Researchers said reproductive improvements appeared earlier than expected, prompting them to report preliminary findings while the wider study continues.

Cree is also a paediatric endocrinologist at Children’s Hospital Colorado.

Endocrinologists are doctors who specialise in hormones and hormone-related conditions.

Cree said: “What makes this work particularly important is that it focuses specifically on women with PMOS receiving injectable semaglutide.

“Although GLP-1 medications have transformed obesity treatment, there remains a significant need for rigorous data examining how these therapies affect fertility and reproductive function in this population.”

The RESTORE study is evaluating semaglutide treatment in girls and women with PMOS and obesity.

Its broader aim is to determine whether weight loss and metabolic improvements can restore ovulation and improve reproductive outcomes.

Ovulation is the release of an egg from the ovary, a key part of the menstrual cycle and fertility.

The authors said the findings are from an early proof-of-concept analysis and that larger, longer-term studies will be needed to confirm whether the reproductive benefits last.

The findings suggest injectable semaglutide may become a treatment option for women with PMOS seeking improvements in both metabolic and reproductive health, if future studies confirm the results.

Continue Reading

Trending

Copyright © 2025 Aspect Health Media Ltd. All Rights Reserved.