Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
Clinical Study Results of the BlueWind System for Patients with Overactive Bladder Featured at the 2023 AUA Annual Meeting
BlueWind Medical, Ltd., the developer of a transformative implantable tibial neuromodulation therapy for Overactive Bladder (OAB), today announced results from the OASIS pivotal trial evaluating the safety and efficacy of the BlueWind System in the treatment of OAB. The results were featured in the late-breaking session (LBA01-05) at the American Urological Association (AUA) 2023 Annual Meeting in Chicago on Sunday, April 30th. Read more.
Source: PRNewswire, May 1, 2023
AUA, SUFU Release an Amendment to the Female Stress Urinary Incontinence Guideline
Today, the American Urological Association (AUA), in partnership with the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU), released the 2023 clinical practice guideline amendment for the surgical treatment of female stress urinary incontinence (SUI). SUI is a common problem experienced by many women. About 1 in 3 women suffer from SUI at some point in their lives, and the chance of having urinary incontinence increases with age. The updated guideline has 24 recommendations that provide a clinical framework for the assessment and treatment of SUI in women. Read more and access the new guideline.
Source: PRNewswire, April 25, 2023
Axonics Acquires Tech to Expedite Placement of Implantable Leads in Sacral Neuromod
Axonics (Nasdaq:AXNX) today announced it acquired lead placement technology from Radian to speed up the placement of implantable leads for sacral neuromodulation. Axonics acquired the assets of Radian from Intermed Labs for an undisclosed amount. The company expects the product to receive FDA clearance and be available on a commercial basis in mid-2024. Read more.
Soure: MassDevice.com, April 24, 2023
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
Touching Film for TENA Goes Behind Closed Doors to Show the Reality of Family Carers
Around one in ten people already look after a loved one [1], yet new research conducted by Essity owned incontinence brand TENA reveals that only 50% of people who provided extended family care considered themselves a ‘carer’. This lack of perception is largely down to those doing the care not acknowledging themselves as ‘carers’ and, as a result, they feel more alone and unaware of the support available. The research, conducted with Ketchum, is part of TENA’s new global campaign #NoLoveLikeIt, which sees the brand also partnering with Carers UK. Committed to providing care for both caregiver and receiver, TENA delved deep into qualitative and quantitative research to understand the realities of caring, which will become a reality for most of us at some point, as populations age and more care is provided in home by families. Read more.
Source: lbbonline, April 12, 2023
Avation Medical Announces US FDA 510(k) Clearance for The Vivally® System
Avation Medical, Inc., the innovator in patient-friendly, closed-loop neuromodulation options to treat life-altering medical conditions, today announced that its Vivally System received US Food and Drug Administration (FDA) 510(k) clearance. Vivally is a non-invasive, bladder control therapy device and mobile application to treat patients with the conditions of urinary urgency and urge urinary incontinence (UUI) caused by overactive bladder (OAB) syndrome, without the need for surgery, drugs, or needle-electrodes. The Vivally System is the only closed-loop, non-invasive neuromodulation system for bladder control cleared for sale in the United States. Closed-loop control objectively confirms activation of the tibial nerve and continuously adjusts therapy parameters to ensure optimal output throughout the session. Read more.
Source: PRNewswire, April 11, 2023
Florida Faces Medicaid Class Action Lawsuit
A judge has cleared the way for a class-action lawsuit alleging that Florida’s Medicaid program has violated federal laws by denying coverage for incontinence supplies for adults with disabilities. U.S. District Judge Marcia Morales Howard issued a 37-page decision granting a request by attorneys for two women and the organization Disability Rights Florida to handle the case as a class action. While it is not clear how many people the case could affect, the decision cited one estimate that at least 480 Medicaid beneficiaries a year turn 21 and lose coverage for incontinence supplies that they received as children. Read more.
Source: CBS Miami, April 10, 2023