Medtech company Becton, Dickinson and Company has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its BD Vaginal Panel on the BD COR System. The comprehensive diagnostic test detects the three most common infectious causes of vaginitis using BD’s molecular diagnostic platform for large laboratories. The BD Vaginal Panel is a microbiome-based polymerase chain reaction (PCR) assay that…
Madorra has developed a non-invasive, home-use therapeutic ultrasound device that can potentially treat vaginal dryness in postmenopausal women with vulvovaginal atrophy (VVA). This condition affects millions of women in the US and is a component of genitourinary syndrome of menopause (GSM). Madorra’s Pilot 1 clinical study, which was published in Menopause, the Journal of the North American Menopause Society (NAMS), showed that…
Femasys, a biomedical company aiming to meet women’s needs worldwide by developing a suite of product candidates that include minimally invasive, in-office technologies for reproductive health, has announced that its product, FemCath, the first FDA-cleared intrauterine catheter for selective tubal evaluation, is now commercially available. FemCath is used in conjunction with Femasys’ FemVue device for an ultrasound-based diagnostic test as part of…
Women’s health focused pharma company Organon has made a $8M strategic investment in Claria Medical, a privately-held company developing an investigational medical device being studied for use during minimally invasive laparoscopic hysterectomy. The agreement also grants Organon the option to acquire Claria Medical in the future. “Hysterectomy is one of the most commonly performed surgeries for women, which is why it is critical…
ASPIVIX, a medical technology company focused on innovations in women’s healthcare and maker of the new generation of non-traumatic cervix stabilizer CAREVIX has raised $5 million in Series A+ funding led by HEMEX. Other participants in the round include existing investors 4FOx ventures and Zürcher Kantonalbank, as well as new investor LaunchPad APAC. ASPIVIX will use this new investment to enter the market in Europe and the…
Hologic, a medtech company primarily focused on improving women’s health is opening a new Innovation Center in Aix-en-Provence, France today . This announcement follows Hologic’s 2019 acquisition of Aix-en-Provence-based SuperSonic Imagine. The new commercial office, training and research and development facility will support Hologic’s ultrasound, interventional and surgical solutions across the continuum of breast health care. Antoine Bara, Hologic France’s General Manager…
Cook Medical has signed a letter of intent with CooperCompanies to sell the entirety of Cook’s Reproductive Health business within the MedSurg division. CooperCompanies, a publicly held healthcare company, is focused on women’s health and fertility solutions, providing innovative products and services for every step in the ART journey. Under the proposed transaction, CooperCompanies will pay $875M comprised of $675M at closing…
Caldera Medical, a medical device company that develops surgical products for the treatment of Stress Urinary Incontinence, Pelvic Organ Prolapse, and Polyps, has announced the launch of Desara TVez. Desera TVez is the newest addition to Caldera Medical’s Desera family of products, that offers surgeons a system that is flexible and easy to use. Commenting on the Desera TVez Launch Caldera Medical CEO…
