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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

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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

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Axonics Receives FDA Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System

Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced that the U.S. Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The newly approved Axonics R20 neurostimulator is labeled for a functional life in the body of at least 20 years and reduces how frequently a patient needs to recharge their implanted device to just once every 6 to 10 months for only one hour.  Read more.

Source: BusinessWire, January 31, 2023

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Axonics® Receives FDA Approval for Recharge-Free Sacral Neuromodulation System

Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced that the U.S. Food and Drug Administration (FDA) has approved its newly developed, long-lived, recharge-free sacral neuromodulation (SNM) implantable neurostimulator (INS).  Read more.

Source: Business Wire, March 7, 2022

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Valencia Technologies Announces FDA Approval of eCoin® Therapy to Treat Urinary Urge Incontinence

Valencia Technologies Corporation, a privately held company, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its eCoin® leadless tibial neurostimulator for the treatment of urinary urge incontinence (UUI), which affects over 60% of patients who suffer from Overactive Bladder (OAB). FDA approval was supported by the efficacy and favorable safety profile demonstrated in the eCoin® pivotal trial. The company also announced the publication of these results in the Journal of Urology®, the official journal of the American Urological Association. Read more.

Source: PRNewswire, March 2, 2022

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Medtronic Receives FDA Approval for InterStim X™ System

Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it received approval from the U.S. Food and Drug Administration (FDA) for InterStim X™ ― the next generation of the InterStim™ portfolio’s recharge-free device – and it is available immediately. InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation (SNM) therapy. Now the only SNM system backed by 90+ clinical studies, 1,000+ clinical articles, 350,000 patients treated and 25 years of experience, also offers patients a decade or more of treatment with either the new recharge-free InterStim X device, or the rechargeable InterStim™ Micro device. Both devices are used in the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention. Read more.

Source: PRNewswire, February 22, 2022

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Caldera Medical Announces FDA Clearance for New Desara® TVez for Stress Urinary Incontinence

Caldera Medical, a medical device company that develops best-in-class surgical products for the treatment of Stress Urinary Incontinence, Pelvic Organ Prolapse, and Polyps announced the launch of Desara® TVez, an expansion to their Desara® Family of products.  Caldera Medical, a medical device company that develops best-in-class surgical products for the treatment of Stress Urinary Incontinence, Pelvic Organ Prolapse, and Polyps announced the launch of Desara® TVez, an expansion to their Desara® Family of products. Read more.

Source: Business Wire, December 2, 2021

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Urovant Sciences Announces U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB)

Urovant Sciences, Inc (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg GEMTESA® (vibegron), a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. Read more.

Source: BioSpace, December 23, 2020

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Vibegron Update Shared as FDA Weighs Approval in OAB

The FDA is considering an application for vibegron for the treatment of patients with OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency. Vibegron continued to demonstrate improved clinical outcomes versus tolterodine in patients with overactive bladder (OAB), according to findings from an extension study of the phase 3 EMPOWUR trial presented during the 2020 International Continence Society (ICS) online meeting. The extension results showed that at week 52, 61% of patients receiving vibegron had a 75% or higher reduction in urge urinary incontinence (UUI) episodes compared with 54.5% of patients who received tolterodine. Additionally, 40.8% versus 34.2% of patients, respectively, had a 100% reduction in UUI episodes and experienced no incontinence episodes over a 7-day diary.  Read more. 

Source: Urology Times, November 20, 2020

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FDA Approves New Devices for Bladder and Bowel Control Conditions

The FDA has approved the InterStim Micro neurostimulator and InterStim SureScan MRI leads for the treatment of patients with bladder and bowel control conditions, according to Medtronic plc, the manufacturer of the devices.  InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering sacral neuromodulation (SNM) therapy. SNM sends “electrical impulses to the sacral nerves located in the lower back to improve bladder and bowel control. Read more.

Source: Urology Times, August 6, 2020