nurse and patient

Pelvital Announces Landmark Study Demonstrating Efficacy of Flyte® Device in Treating Stress Urinary Incontinence

Pelvital, the women’s health MedTech company on a mission to transform the standard of care for urinary incontinence, announced today the publication of its landmark paper “Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women” in the peer-reviewed journal Therapeutic Advances in Urology. The paper presents evidence of the efficacy of Pelvital’s novel, FDA-cleared device, Flyte, for the treatment of stress urinary incontinence (SUI) and weakened pelvic floor muscles, with results comparable to surgical intervention. Read more.

Source: PRNewsire, February 21, 2024

women exercising

JUNOFEM Seeks FDA Approval for Innovative ‘femfit’ Incontinence Device in the US

JUNOFEM, a medical equipment supplier based in Auckland, New Zealand, has taken a significant step toward introducing their innovative ‘femfit’ female incontinence device to the American market by applying for FDA approval. After two years of dedicated work on their 510(k) pre-market submission, JUNOFEM aims to gain access to the US market upon FDA approval.  The femfit® Pelvic Floor Training Tool is a cutting-edge device designed for female pelvic floor muscle exercises. Read more.

Source: UniverseNews Network, December 7, 2023

business buildings

Caldera Medical Acquires Atlantic Therapeutics to Expand Portfolio in Women’s Health

Caldera Medical, a women’s health medical device company that develops and markets best-in-class products for the treatment of Stress Urinary Incontinence, Pelvic Organ Prolapse, Polyps and Fibroids, announced today that it has completed its acquisition of Atlantic Therapeutics, an Ireland based provider of non-invasive pelvic floor strengthening and nerve stimulating solutions for women. The acquisition bolsters Caldera Medical’s expanding portfolio, furthering its mission to improve the quality of life for women! Read more.

Source: Business Wire, September 6, 2023

business buildings

UroMems Granted Safer Technologies Program Designation from FDA for Smart Implant to Treat Stress Urinary Incontinence

UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that they have received Safer Technologies Program (STeP) designation from the U.S. Food and Drug Administration (FDA) for UroActive Smart Continence Therapy. STeP is a collaborative program intended to help reduce the time it takes to develop and obtain marketing authorization for eligible devices. Read more.

Source: PRNewswire, April 20, 2023