Medical Device

Medical Device Company Caldera Medical Acquires Atlantic Therapeutics; Adds SUI Treatment INNOVO to Portfolio

Caldera Medical, a Los Angeles-based medical device company has announced the completion of its acquisition of Atlantic Therapeutics, an Ireland-based medical device provider specializing in non-invasive pelvic floor strengthening and nerve-stimulating solutions. Caldera Medical specializes in products for the treatment of Stress Urinary Incontinence, Pelvic Organ Prolapse, Polyps, and Fibroids. The company is committed to improving the quality of life for women…

Brunel University Student Develops New Discreet Cooling Device to Control Menopausal Hot Flashes

The management of menopausal symptoms, particularly hot flashes, has taken a significant step forward with the introduction of the Zera Cooling Crescent. Developed by Aphra Hallam, a 22-year-old Industrial Design and Technology student at Brunel University London, this innovative device offers discreet and effective relief for women experiencing this common discomfort. Historically, menopause has been a topic of limited discussion and understanding,…

Nesa Medtech’s Fibroid Mapping Reviewer Application Gains FDA Approval

Indian femtech company Nesa Medtech has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Fibroid Mapping Reviewer Application (FMRA). The Software as a Medical Device (SaMD) creates a 3D model of the uterus from ultrasound images, helping physicians diagnose and plan treatments for patients with symptomatic uterine fibroids. Uterine fibroids, also known as leiomyomas, are non-cancerous growths…

Women-Led Vertex Ventures HC Launches $200M Fund III to Back Life Sciences and Medtech Companies

Vertex Ventures HC, a global healthcare investment firm led by women, has announced the launch of its third and largest fund of $200M, Fund III. The primary objective of Fund III is to back life sciences and medical technology companies focused on driving advancements in healthcare anad enhancing patient outcomes. “As technology continues to reshape industries and science continues to advance, VVHC…

Ceek Women’s Health Launches Nella, A New Single-Use Vaginal Speculum Designed for Patient Comfort

Founded in 2018 by Fahti Khosrowshahi following her personal experiences with infertility treatments, Ceek Women’s Health aims to revolutionize gynecological care. Recognizing the need for more modern, patient-friendly tools in this sector, Khosrowshahi’s company is dedicated to developing innovative solutions that elevate the standard of care women receive. With the launch of the Nella Single-Use Vaginal Speculum the company is not taking…

BD Receives FDA Clearance for Its High-Throughput Diagnostic Test for Infectious Vaginitis

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’s Device Could Offer a New, Nonhormonal Treatment Option for Post-Menopausal Women with Vaginal Atrophy

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’ FemCath, an Intrauterine Device for Selective Tubal Evaluation, Is Now Commercially Available

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…