Latest Research, Industry, Medical and Scientific News
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
Urology Fellowship Program Celebrated After 20 Years
A two-year urology fellowship training program focused on women’s urologic health and reconstruction, known as Female Pelvic Medicine and Reconstructive Surgery (FPMRS), is celebrating its 20th anniversary and graduating its 20th fellow in June at Vanderbilt University Medical Center. FPMRS fellows, selected one per year after completing a urology residency, spend two years learning to manage adult patients with urinary and pelvic conditions including urinary incontinence, pelvic organ prolapse, voiding dysfunction and neurogenic lower urinary tract dysfunction. Additional aspects of pelvic and urinary reconstruction include surgical repair of urinary fistulas, diverticular disease, urinary diversion and cancer survivorship. FPMRS is a multidisciplinary subspecialty that includes both urologists and gynecologists, all of whom complete the same fellowship-level training regardless of background. Read more.
Source: VUMC Reporter, March 30, 2023