Urinary incontinence

Bridging Healthcare Gaps: The Wonder Woman Collective Unveils a New Vision for Women's Health

Retrieved on: 
Vendredi, mai 3, 2024
PCOS, Health equity, Urinary incontinence, Wonder, Infertility, Health, McKinsey & Company, Partnership, Human, Research, Pelvic floor dysfunction, Pelvic floor, Grammatical mood, Hypothyroidism, IVF, Entrepreneurship, Mental health, Patient, Work, Mother, Diagnosis, Migraine, Menopause, Quality of life, Nursing

With a shared commitment to innovation and excellence, this is the start of a foundation where future companies can join and redefine the standard of care in women's health. "With this initiative, we forge a new path in healthcare - one where comprehensive care, innovation, and patient-centricity are not just ideals, but realities. This is where the future of women's health begins." said Elizabeth Burstein, Co-Founder and CEO of Neura Health. Tina Keshani, Founder and CEO of Seven Starling adds "Women deserve specialized and tailored healthcare solutions to address their unique needs -- and no one company can do it all. "

Key Points: 
  • Five leading women's health companies, Paloma Health, Neura Health, LEVY Health, Seven Starling and Origin, have joined forces to announce The Wonder Woman Collective.
  • This strategic partnership addresses critical gaps in women's healthcare, focusing on improving healthcare outcomes, promoting health equity, reducing costs, and enhancing women's health.
  • "Addressing the Women's Health Gap is not just an option but a critical necessity.
  • "Through The Wonder Woman Collective, we are unifying diagnostic expertise and specialized care, enhancing the patient's journey and offering timely, comprehensive solutions," said Caroline Mitterdorfer, Co-Founder and CEO of LEVY Health.

Implantable Tibial Nerve Stimulation added as Treatment Option within AUA/SUFU 2024 OAB Guideline

Retrieved on: 
Jeudi, mai 2, 2024
Leg, FDA, Physician, Society, Patient, Diagnosis, Urinary incontinence, American Urological Association, Health, OAB, Treatment, AUA, Fascia, SUFU, Guideline, Quality of life, PMA, Female, Nursing

The eCoin® ITNS device is the only fully implantable FDA PMA approved device for treating urge urinary incontinence (UUI), the primary symptom of OAB.

Key Points: 
  • The eCoin® ITNS device is the only fully implantable FDA PMA approved device for treating urge urinary incontinence (UUI), the primary symptom of OAB.
  • This highlights the significant need for evolutionary treatment options to address the growing burden of a largely underserved OAB population.
  • "Valencia Technologies is humbled and honored to have the opportunity to take a lead role in the implantable tibial nerve stimulation space."
  • The eCoin® device contains a primary-cell battery that once activated, automatically delivers intermittent stimulation to the tibial nerve to reduce UUI symptoms.

AUA/SUFU Guideline on the Treatment of Overactive Bladder Allows Access to ReviTM System Earlier in Treatment Journey

Retrieved on: 
Lundi, avril 29, 2024
FDA, Commercial software, Society, Risk, Urinary incontinence, Food, De novo, American Urological Association, Paruresis, Pharmacotherapy, MMHC, Guideline, OAB, Deficit spending, Prescription, Patient, Neuromodulation, Physician, AUA, Ankle, Diagnosis, SUFU, Anticholinergic, Female

The revised guidelines are a major affirmation of the importance of Revi as a therapy for patients with UUI.

Key Points: 
  • The revised guidelines are a major affirmation of the importance of Revi as a therapy for patients with UUI.
  • First, the guidelines were updated to include iTNM as an acceptable minimally invasive therapy.
  • "We are delighted to witness the transformation of the new OAB treatment guideline by the AUA/SUFU.
  • This guideline represents a significant turning point in physicians' approach to OAB management," commented Dan Lemaitre, Chief Executive Officer of BlueWind Medical.

Affluent Medical : 2023 financial results and update on clinical activities under development.

Retrieved on: 
Vendredi, mai 3, 2024
Medtech, FDA, Risk, De novo, Death, Mitral regurgitation, Doctor of Philosophy, Wound healing, Mitral valve annuloplasty, Boston Scientific, Ticker, Wealth, Urinary incontinence, Woman, Christophe, Food, Neurostimulation, Myocardial infarction, Aix-en-Provence, DSM-IV codes, LCEA, Mitral valve, TAVI, Minerva, Certification, Heart, Quality assurance, System, Anatomy, Exercise, NYHA, Dry, Marketing, Clinical trial, American College, Development director, MD, Endocarditis, Medtronic, Patient, Tricuspid valve, Acquisition, Medical device

Affluent Medical : 2023 financial results and update on clinical activities under development.

Key Points: 
  • Affluent Medical : 2023 financial results and update on clinical activities under development.
  • Affluent Medical estimates that KaliosTM would avoid repeat surgery for 30-40% of patients within five years of their operation.
  • In September 2023, the Company presented interim data on 20 patients treated in five clinical centers in Europe after one year of implantation.
  • In July 2023, Affluent Medical announced the appointments of Christophe de Vregille as Chief Financial Officer and Benjamin Renault as Development Director.

Zydus launches Mirabegron Extended-Release Tablets in the US

Retrieved on: 
Lundi, avril 22, 2024
Biotechnology, General Health, Pharmaceutical, Health, Zydus Lifesciences, USP, Patient, Overactive bladder, USFDA, Mirabegron, Urinary incontinence, OAB, Generic drug

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) announces the launch of Mirabegron Extended-Release Tablets, 25 mg in the US market.

Key Points: 
  • Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) announces the launch of Mirabegron Extended-Release Tablets, 25 mg in the US market.
  • The company had earlier received final approval from the United States Food and Drug Administration (USFDA) to market Mirabegron Extended-Release Tablets USP 25 mg and 50 mg (USRLD: Myrbetriq® Extended-Release Tablets).
  • Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market and is prepared to launch Mirabegron Extended-Release Tablets, 50mg imminently.
  • Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.

Axena Health receives two additional positive insurance coverage decisions for Leva

Retrieved on: 
Jeudi, avril 11, 2024
Medical Devices, Women, FDA, Health Technology, Health Insurance, Biotechnology, Health, Consumer, Pharmaceutical, UI, Urinary incontinence, Woman, BCBS, Food, Cigna, The Institute, Leva, MD, Highmark, Life, Pelvic floor, Female, Pelvic organ prolapse, Privacy, Incontinence, Overactive bladder, Storey, MBA, FACOG, Food and Drug Administration, HCPCS, Nursing

Both positive coverage decisions became effective on April 1, 2024.

Key Points: 
  • Both positive coverage decisions became effective on April 1, 2024.
  • “Axena Health is focused on providing evidence-based solutions through both formal clinical trials with world-class academic institutions and published real-world evidence.
  • “Two more positive coverage decisions for the Leva System means more women can access effective, first-line treatment for UI.
  • Highmark BCBS and BCBS of ND have joined Cigna in demonstrating their clear commitment to women’s health.

75% OF WOMEN AGES 18-59 EXPERIENCED MULTIPLE PELVIC HEALTH ISSUES IN THE PAST YEAR ACCORDING TO A NEW STUDY BY ORIGIN AND IPSOS

Retrieved on: 
Mercredi, avril 17, 2024
Pelvis, News, Woman, Urinary incontinence, Constipation, Ipsos, Depression, Pelvic floor, Origin, PFD, Pelvic floor dysfunction, Gen, Mental health, Patient, Pelvic pain, Movement, Anxiety, Prevalence, Birth control

LOS ANGELES, April 17, 2024 /PRNewswire/ -- Origin, the leading nationwide provider of pelvic floor and women's health physical therapy, today released the "2024 Origin Pelvic Health Study," conducted by market research firm Ipsos and made possible by funding organized by Rise Together Ventures.

Key Points: 
  • LOS ANGELES, April 17, 2024 /PRNewswire/ -- Origin, the leading nationwide provider of pelvic floor and women's health physical therapy, today released the "2024 Origin Pelvic Health Study," conducted by market research firm Ipsos and made possible by funding organized by Rise Together Ventures .
  • The study reveals a hidden pelvic health crisis among women ages 18-59, not just for Gen X women, but also a shockingly high number of Millennials as young as 27.
  • Reported symptoms include bladder and bowel issues, sexual dysfunction, and pelvic pain.
  • At Origin, 9 out of 10 of patients report an improvement in pelvic floor symptoms.

CLS Americas Announces 2nd Order of TRANBERG™ Focal Laser Ablation Accessories Placed by the National Institutes of Health Clinical Center

Retrieved on: 
Mardi, avril 9, 2024
Diagnosis, Temperature, Urology, Prostate cancer, Patient, NIHCC, FLA, NIH, Male, Urinary incontinence, Erectile dysfunction, CLS, Bangladesh Technical Education Board, Medical imaging

LOS ANGELES, April 09, 2024 (GLOBE NEWSWIRE) -- Clinical Laserthermia Systems Americas, Inc. (CLS), a leading provider of office-based, focal laser ablation (FLA) systems for urologists, today announced it has received its second order from the National Institutes of Health Clinical Center (NIHCC) for its TRANBERG™ Thermal Therapy System accessories.

Key Points: 
  • LOS ANGELES, April 09, 2024 (GLOBE NEWSWIRE) -- Clinical Laserthermia Systems Americas, Inc. (CLS), a leading provider of office-based, focal laser ablation (FLA) systems for urologists, today announced it has received its second order from the National Institutes of Health Clinical Center (NIHCC) for its TRANBERG™ Thermal Therapy System accessories.
  • The order falls under the previously announced research collaboration agreement between NIHCC and its parent company, Clinical Laserthermia Systems AB, based in Sweden.
  • “This second order of our TRANBERG Focal Laser Ablation accessories enables our continued collaboration with the NIH to evaluate our TRANBERG laser for image-guided, focal therapies to treat prostate cancer,” said Michael Magnani, President of CLS Americas.
  • It includes a desk-top mobile laser unit, innovative non-cooled laser applicators, tissue temperature probes, and procedure-specific accessories.

CLS Americas Announces ROSE Urology will use TRANBERG Laser to Treat Prostate Cancer Patients with Focal Laser Ablation

Retrieved on: 
Jeudi, mars 28, 2024
Diagnosis, Temperature, Urology, Prostate cancer, Patient, Cancer, Prostate, FLA, Urinary incontinence, Erectile dysfunction, CLS, FDA, Physician, Medical imaging

LOS ANGELES, March 28, 2024 (GLOBE NEWSWIRE) -- Clinical Laserthermia Systems Americas, Inc. (CLS), a leading provider of office-based, focal laser ablation (FLA) systems for urologists, today announced that ROSE Urology, LLC , located in Vero Beach, Florida, will begin using the TRANBERG™ Thermal Therapy System to treat prostate cancer patients.

Key Points: 
  • LOS ANGELES, March 28, 2024 (GLOBE NEWSWIRE) -- Clinical Laserthermia Systems Americas, Inc. (CLS), a leading provider of office-based, focal laser ablation (FLA) systems for urologists, today announced that ROSE Urology, LLC , located in Vero Beach, Florida, will begin using the TRANBERG™ Thermal Therapy System to treat prostate cancer patients.
  • The system is FDA 510(k) cleared for soft tissue ablation in a urology setting.
  • Operating under CLS's Mobile Services Agreement, CLS will provide its FDA 510(k) cleared TRANBERG Laser, consumable accessories, training, and on-site clinical and technical support to ROSE Urology physicians and staff during procedures.
  • Focal laser ablation of prostate tumors has demonstrated high levels of precision and accuracy with low risk of side effects, such as erectile dysfunction and urinary incontinence.

SpineX Closes Recruitment for SCONE™ Clinical Trial

Retrieved on: 
Lundi, avril 8, 2024
Children, Biotechnology, FDA, Health, Neurology, Health Technology, Medical Devices, Research, Consumer, Science, Clinical Trials, Cord, Brain, Cerebral palsy, Multiple sclerosis, SCIP, Patient, Stroke, Clinical trial, Urinary bladder, Trial of the century, Skin, Spinal cord, Heart, Urinary incontinence, Cauda equina syndrome, Neuromodulation, Pharmaceutical industry

SpineX Inc. has closed recruitment for its clinical trial of its proprietary SCONE™ device.

Key Points: 
  • SpineX Inc. has closed recruitment for its clinical trial of its proprietary SCONE™ device.
  • The clinical trial— Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE “CONTINENCE” Clinical Study — began in May 2022.
  • “SCONE has the power to transform the lives of millions of patients with neurogenic bladder,” says Parag Gad, SpineX co-founder & CEO.
  • SpineX anticipates beginning a multi-center pivotal trial for children with Cerebral Palsy in 2024.