• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    MPO's 2023 Medical Device Industry Year in Review

    The Beat Goes On in the Cardiovascular Device Market

    Medical Manufacturers Gain Support from 3D Printing

    The Intelligent Tools Medical Device Manufacturers Already Own

    MPO's 2023 Medtech Supply Chain Survey
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    ResMed Scores Legal Wins in Patent Spat with NYU

    NeuroOne Receives FDA Clearance for Ablation System

    AdvaMed Names GE HealthCare Leader Peter J. Arduini as Chairman

    Hologic Promotes Essex D. Mitchell to COO

    Medtronic, Cosmo Pharmaceuticals Fortify AI-Driven Endoscopy Partnership
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    MPO's 2023 Medical Device Industry Year in Review

    The Beat Goes On in the Cardiovascular Device Market

    Medical Manufacturers Gain Support from 3D Printing

    The Intelligent Tools Medical Device Manufacturers Already Own

    MPO's 2023 Medtech Supply Chain Survey
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    A Peek Into the 2028 MPO Summit

    Retail Healthcare Disruptors and Medical Devices

    Six Developments Your Talent Strategy Should Prepare for in 2024

    The Power and Paradox of Never

    Navigating the Q-Sub Program: How Experienced Lab Partners Can Help Streamline Regulatory Submission
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Poly-Med, Inc.

    Providence Enterprise USA Inc.

    maxon

    Braxton Manufacturing

    Cirtec Medical
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Telemedicine for Neurology: 5 Benefits of Remote Management

    Machining 101: A Review of Machining Components with a Five-Axis System

    MedTech 2024: Top 5 Trends Shaping a Dynamic Industry

    Early Warning: A Q&A with Abbott's CMO of Heart Failure

    2023 in Review: Medtech's Mega-M&A Is MIA
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Poly-Med, Inc.

    Providence Enterprise USA Inc.

    maxon

    Braxton Manufacturing

    Cirtec Medical
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    FDA OKs Pelvital's In-Home Pelvic Floor Muscle Treatment for Stress Urinary Incontinence

    First-of-its-kind, non-invasive, intravaginal home-use device strengthens the pelvic floor muscles.

    FDA OKs Pelvital
    More than 15 million American women suffer from stress urinary incontinence. Flyte is a new, FDA-cleared, clinically proven treatment that women can use from the convenience of home. Image courtesy of Business Wire.
    Business Wire08.21.20
    Pelvital, a medical technology company focused on women’s health, has received U.S. Food and Drug Administration (FDA) clearance for Flyte, a first-of-its-kind, non-invasive, intravaginal home-use device that is intended for strengthening of the pelvic floor muscles, which has been found to help women with stress urinary incontinence.
     
    According to the National Association for Incontinence, stress urinary incontinence (SUI) affects an estimated 16.6 million women in the United States. The condition often occurs because pelvic floor muscles and tissues have been weakened, preventing the urethra from closing adequately to hold urine in the bladder. Pelvital’s Flyte is the only product to use an expanding area of treatment called mechanotherapy (the treatment of disease by physical or mechanical means) to treat pelvic floor muscle weakness, the primary underlying cause of female SUI.
     
    “Proven in physician-led clinical studies, Flyte leverages the natural healing capabilities of skeletal muscle to provide a time-efficient, effective therapy that essentially turbo charges Kegel exercises, the gold standard conservative treatment for SUI. Flyte amplifies the treatment impact of Kegels so women see results much sooner; days to weeks instead of months to years,” said Dale Wahlstrom, Co-Founder and CEO of Pelvital.
     
    “Many women are just coping with SUI. Women with mild, moderate or severe SUI who want to avoid surgery, or a lengthy regimen of Kegel exercises now have a new option to treat their bladder leaks,” said Carrie Vollmer, Vice President of Marketing. “Flyte is an easy-to-use, 5-minute-per-day treatment that is backed by strong clinical evidence.”
     
    Flyte was originally developed by physicians from the Arctic University of Norway and other experts in gynecology, muscle rehabilitation and urinary incontinence treatments. Two clinical trials studied the safety and effectiveness of Flyte in Norway and the United States. Between the two studies, more than 200 patients were treated using Flyte; most patients were dry or near dry after 2 – 12 weeks of treatment.
    Related Searches
    • Neurological
    Related Knowledge Center
    • Neurological
    Suggested For You
    Breakthrough Device Designation Granted for New Neuromodulation Platform Breakthrough Device Designation Granted for New Neuromodulation Platform
    First CellFX Procedure Performed in Canada First CellFX Procedure Performed in Canada
    RedDress’ ActiGraft System Receives New FDA Clearance RedDress’ ActiGraft System Receives New FDA Clearance
    Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings
    Precision Coating Merges with N2 Biomedical Precision Coating Merges with N2 Biomedical
    FDA Approves Abbott FDA Approves Abbott's Portico with FlexNav TAVR System
    Medical Devices Market to Top $671.49 Billion by 2027 Medical Devices Market to Top $671.49 Billion by 2027
    Improved Outcomes Proven With Insulet’s Omnipod 5 System Improved Outcomes Proven With Insulet’s Omnipod 5 System
    Molli Surgical Molli Surgical's Breast Tumor Marker
    The Benefits of Computer Vision Technology for Healthcare Applications The Benefits of Computer Vision Technology for Healthcare Applications
    Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe
    Vertigo Treatment Receives FDA Breakthrough Device Designation Vertigo Treatment Receives FDA Breakthrough Device Designation
    RapidAI Launches Rapid Workflow for Pulmonary Embolism RapidAI Launches Rapid Workflow for Pulmonary Embolism
    Quanta Raises $245 Million in Series D Funding Round Quanta Raises $245 Million in Series D Funding Round
    Glytec Appoints Nausheen Moulana as Chief Technology Officer Glytec Appoints Nausheen Moulana as Chief Technology Officer

    Related Breaking News

    • Breakthrough Device Designation Granted for New Neuromodulation Platform

      Breakthrough Device Designation Granted for New Neuromodulation Platform

      In a pilot study treating refractory epilepsy with Neuroelectrics’ Starstim platform, patients experienced a 44 percent median reduction in seizure frequency.
      Business Wire 09.22.21

    • First CellFX Procedure Performed in Canada

      First CellFX Procedure Performed in Canada

      Pulse Biosciences expands its controlled launch of the CellFX System into the country.
      Business Wire 09.22.21

    • RedDress’ ActiGraft System Receives New FDA Clearance

      RedDress’ ActiGraft System Receives New FDA Clearance

      ActiGraft Ver.02 System is intended for the safe and rapid POC preparation of an in-vitro blood clot.
      Globe Newswire 09.22.21


    • Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings

      Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings

      The two deals will strengthen Heraeus' healthcare and medtech portfolio.
      Heraeus 09.22.21

    • Surgical
      Precision Coating Merges with N2 Biomedical

      Precision Coating Merges with N2 Biomedical

      Expands its medical coatings platform.
      Ampersand Capital Partners 09.20.21

    Loading, Please Wait..

    Breaking News
    • ResMed Scores Legal Wins in Patent Spat with NYU
    • NeuroOne Receives FDA Clearance for Ablation System
    • AdvaMed Names GE HealthCare Leader Peter J. Arduini as Chairman
    • Hologic Promotes Essex D. Mitchell to COO
    • Medtronic, Cosmo Pharmaceuticals Fortify AI-Driven Endoscopy Partnership
    View Breaking News >
    CURRENT ISSUE

    November 2023

    • MPO's 2023 Medical Device Industry Year in Review
    • The Beat Goes On in the Cardiovascular Device Market
    • Medical Manufacturers Gain Support from 3D Printing
    • The Intelligent Tools Medical Device Manufacturers Already Own
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Cognitive Health Tops Charts of Prinova’s 2024 Food/Nutrition Mega-Trends Report
    EpiCor Postbiotic Receives Health Canada Approved Immune, Gut Health Claims
    Women in Nutraceuticals Hires Executive Director Rebecca Takemoto
    Coatings World

    Latest Breaking News From Coatings World

    INEOS Completes Acquisition of Eastman's Acetic Acid Plant in Texas
    DuPont Co-Launches PVF Coating Solution with Nippon Paint
    PPG Brings PPG MOONWALK Automated Paint Mixing System to Mexico
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    ResMed Scores Legal Wins in Patent Spat with NYU
    NeuroOne Receives FDA Clearance for Ablation System
    AdvaMed Names GE HealthCare Leader Peter J. Arduini as Chairman
    Contract Pharma

    Latest Breaking News From Contract Pharma

    RoslinCT to Manufacture CRISPR-based Gene Therapy CASGEVY
    DifGen Pharmaceuticals Acquires KriGen
    Ferring, PharmaBiome Partner on Microbiome R&D
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Bliss Partners with Crunch to Bring Self-Care Skincare to Gym Goers
    Selena Gomez’s Rare Beauty Expands into Scented Body Care Category
    Peach Fuzz is Pantone’s Color of the Year 2024
    Happi

    Latest Breaking News From Happi

    Premium Beauty & Personal Care Products Market: $780.16 Billion by 2032
    Bliss Partners With Crunch Gym
    New Kenvue Study Shows Sunscreen UV Filter Rinse-off Varies
    Ink World

    Latest Breaking News From Ink World

    INEOS Concludes Acquisition of Eastman's Acetic Acid Plant in Texas
    Solvay Concludes Syensqo Spin-off
    Weekly Recap: Siegwerk, DIC, and Müller Martini Top This Week’s Stories
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    CRG promotes Ginnie Gandy to sales manager, Release Liner
    Analyzing the Russian label market, Cartes boosts brands and more
    FLAG’s December Lunch & Learn to feature Omet
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Autoneum Offers Propylat Sustainable Acoustic Technology
    Ahlstrom Announces Change to Board
    Partners Group Acquires Velvet Care
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    OssDsign Realigning its Strategy to Focus on Orthobiologics
    ODT's Most-Read Stories This Week—Dec. 9
    Fujitsu, iSurgery Launch Bone Health Promotion Project in Japan
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Zebra Earns Highest Score on CEI
    SEMI Applauds Advancement of US Chips Act Incentives
    Weekly Recap: Schreiner MediPharm, GIANCE and PragmatIC Top This Week’s Stories

    Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login