Mirvie Inc. has secured U.S. FDA breakthrough device designation for its pre-eclampsia risk test. The blood test combines machine learning and liquid biopsy technology to provide an RNA profile that predicts pregnancy risks before symptoms occur. It is the first test to be recognized by the FDA for the early identification of pre-eclampsia.
Truscreen Group Ltd. completed its largest clinical trial to date that showed its cervical cancer screening device surpassed liquid-based cytology (LBC) screening in 15,651 women across 64 hospitals in nine provinces in China over three years.
The U.S. FDA has given the green light to a pelvic organ prolapse (POP) repair device developed by Misgav, Israel-based Escala Medical Ltd. The mesh-free, non-surgical repair system is designed to anchor sutures to ligaments of the pelvic floor in an incision-free procedure. Escala, which is a portfolio company of Israeli government franchised incubator Trendlines Group Ltd., believes the device will help the 1 in 5 women in the U.S. affected by POP.
Musculoskeletal (MSK) care company Sword Health Inc. has released a new digital therapy focused on pelvic pain and postpartum recovery. The Bloom sensor tracks and measures the pressure of the pelvic floor, with real-time feedback provided via an app. The technology then combines with clinical guidance from pelvic health specialists to help women create personalized exercise programs.
PARIS – Ziwig SAS has developed the Endotest saliva test, for quickly detecting endometriosis. François Golfier, head of the gynecology-obstetrics department at Angers University Hospital and chairman of the endometriosis committee for the National College of French Gynecologists and Obstetricians, claims this new generation of in vitro diagnostic medical devices is going to be a game-changer “as it finally allows this chronic debilitating disease to be detected sooner and within the space of just a few days.”
The Cooper Companies Inc. plans to acquire the entirety of Cook Medical Inc.’s reproductive health business in this fiscal quarter for $675 million at closing plus $200 million paid in four $50 million annual installments. The acquisition will expand Cooper’s presence in the Asia-Pacific region. The Cook deal will also accelerate Cooper’s labor and delivery medical device efforts by adding 115 people sales, marketing, education and support staff globally.
San Francisco-based startup Mirvie Inc. has released data demonstrating how its RNA platform technology can predict preterm birth. The research, presented at the Society for Maternal-Fetal Medicine 42nd Annual Pregnancy Meeting (SMFM 2022), showed the company’s test predicted the condition months before symptoms occurred and identified biological pathways that drive changes in pregnancy.
Molecular diagnostics could dramatically improve care for one of the most common infections women face, vaginitis. A study by Becton, Dickinson and Co. (BD) found that clinicians miss more than 45% of positive cases and misidentify an additional 12% of negative cases as positives when compared to diagnostic findings.
TORONTO – Hyivy Health Inc. has secured CA$1.1 million (US$888,000) in pre-seed funding to manufacture, test and obtain medical device approval for a women’s pelvic rehabilitation platform and to explore its use for relieving pelvic pain during clinical trials this summer.
With the evidence that sex and gender both significantly affect the course of many diseases and the function of medical devices rapidly mounting, the FDA’s Center for Devices and Radiological Health (CDRH) released its strategic plan to better understand these differences.
