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Latest Research, Industry, Medical and Scientific News

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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

product approval introduction

BlueWind Medical’s Revi™ System Secures U.S. FDA De Novo Classification Grant for the Treatment of Urgency Incontinence

BlueWind Medical, Ltd. today announced that the US Food and Drug Administration (FDA) granted a De Novo marketing request for the Revi System, a transformative tibial neuromodulation therapy for the treatment of the symptoms of urgency incontinence alone or in combination with urinary urgency. Physicians should follow clinical guidelines as applicable and should use their discretion to determine if Revi can be used before patients fail or not tolerate more conservative therapy. The De Novo grant is for men and women with urge urinary incontinence (UUI) and was based on results from the OASIS pivotal trial, in which Revi demonstrated statistically significant improvement in the reduction of symptoms of UUI compared to baseline and a favorable safety profile. Read more.

Source: PRNewswire, August 17, 2023

nursing home patients

Incontinence Management: A Crisis In Plain Sight

I find often when trying to help providers improve their quality and operational performance metrics, most of the time they are overlooking or ignoring a major foundational concept. Two-thirds of the clinical pathways or critical elements that CMS has sent forth often involve the incontinence ecosystem (See Figure 1). Incontinence, as stated in some of my previous articles, needs to be taken seriously when trying to improve overall quality. Read more.

Source: McKnight’s Long Term Care News, August 9, 2023

Bacteria

Vaginal Estrogen Effective Against Recurrent UTIs

According to a recent study published in the American Journal of Obstetrics & Gynecology, vaginal estrogen is effective in preventing recurrent urinary tract infections (UTIs) in women with hypoestrogenism. Over 60% of women are impacted by UTIs in their lives, costing over $2 billion per year in the United States. Breakthrough infections even while on active antibiotic suppression are reported in 70% to 80% of recurrent UTI cases. Read more.

Source: Contemporary OB/GYN, August 10, 2023

Drug-coated Balloon Gets FDA Clearance for Treating Enlarged Prostate

Benign prostatic hyperplasia — or BPH, more commonly known as an enlarged prostate — is common among older men. As many as 30% of those aged 80 or more years have severe enough symptoms — including urinary incontinence — to require treatment.  One nonsurgical solution, balloon dilation, can be used to widen the urinary tract and has been around for several decades, but an innovative version of this tool recently received federal clearance and now is being used commercially. Read more.

Source: McKnight’s Senior Living, August 7, 2023

children pediatric classroom

New Muscle Therapy Gets Fast-Track Boost

To help bring therapies for rare muscle diseases in children to market sooner, the Berlin-based start-up MyoPax, a spin-off from the Max Delbrück Center and Charité – Universitätsmedizin Berlin, has now received a boost from the U.S. Food and Drug Administration (FDA). The company has been granted the FDA’s orphan drug designation (ODD) and rare pediatric disease designation (RPDD), both of which offer multiple regulatory and financial advantages – including fast-track approval status and, eventually, market exclusivity. Read more.

Source: Eurekalert, July 26, 2023