• 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
    Adding Fabrication Capabilities: Additive Manufacturing for Production Parts

    Delivering the Goods: The Evolving World of Combination Products

    Anxious Undertones: The 2019 Year in Review

    From Art to Science: The Changing Face of Extrusion

    Exact Science: A Micromolding Roundtable
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    MedStar Health and Cleveland Clinic Innovations Awarded Grant

    3M to Sell Drug Delivery Business for $650M

    First U.S. Patient Implanted With Axonics' Sacral Neuromodulation System

    First U.S. Patients Treated With a Minimally Invasive, Forward Flow Heart Pump

    New Pocket Ultrasound Scanners Smaller, More Powerful, and More Affordable
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Adding Fabrication Capabilities: Additive Manufacturing for Production Parts

    Delivering the Goods: The Evolving World of Combination Products

    Anxious Undertones: The 2019 Year in Review

    From Art to Science: The Changing Face of Extrusion

    Exact Science: A Micromolding Roundtable
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    From Genome Sequencing to the World’s First Portable MRI

    An Update on Digital Health

    ‘If You’re Reading This, You Need to Be at This Meeting’

    Five Steps for Succeeding Globally in Medtech

    Unlocking Market Doors with Real-World Evidence
    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
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    RJG Inc.

    Accumold

    Fusion Biotec Inc.

    Nelson Laboratories LLC

    NN Life Sciences/Paragon Medical
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    EU's MDR: Irresistible Force Meets Immovable Object

    Ladies First: An Examination of the Women's Health Device Industry

    Localizing Medical Devices

    Sounding Board: Looking Back at 2019 and Gazing at 2020

    Understanding Key Processes for Mixing APIs with Silicone
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Halkey-Roberts Corporation

    Fusion Biotec Inc.

    Lyons

    Accumold

    Pulse Systems
    • 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
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • 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

    FRESCA Medical's Low Airflow CPAP System for Sleep Apnea Wins FDA Nod

    Novel low-flow technology has demonstrated efficacy in obstructive sleep apnea patients.

    FRESCA Medical
    Related CONTENT
    • 23andMe Granted First FDA Authorization for Direct-to-Consumer Cancer Risk Genetic Test
    • Jan Medical Partners with U.S. Army for Investigational Concussion Diagnosis Device
    • FDA Authorizes First Test for Emerging Pathogen Candida Auris
    • Software Validation: How It Should Be Done
    • Quality Nightmares #38: Audit Selection
    PR Newswire06.25.18
    FRESCA Medical Inc., a privately held sleep solutions and connected health company, announced today that the U.S. Food and Drug Administration (FDA) granted their de novo request to market the CURVE Positive Airway Pressure delivery system for the treatment of obstructive sleep apnea (OSA).  The de novo pathway is reserved for marketing approval of novel devices of low to moderate risk. The FRESCA system includes a dedicated flow generator, a lightweight and ergonomic air delivery hose, and a comfortable nasal pillow patient interface. The key to the system is FRESCA's novel, patented SmartValve technology which enables the system to treat OSA with far less airflow than conventional CPAP systems, and has the potential to solve many of the complaints that cause sleep apnea sufferers to abandon therapy or refuse to even try CPAP. Scientific literature reports extremely high rates of patient dissatisfaction with CPAP, and treatment abandonment rates of up to 50 percent.1 Currently, for every patient in treatment, there are at least four additional sleep apnea sufferers who are undiagnosed or refuse treatment. The World Health Organization estimates that at least 100 million adults suffer from sleep apnea globally, creating a $35 billion market opportunity for a treatment that is both effective and embraced by patients.
     
    An analysis commissioned by the American Academy of Sleep Medicine showed that treating OSA with positive airway pressure has been shown to save healthcare systems money in the first year.  Sleep apnea is one of the few chronic diseases where there is such a rapid return on investment in diagnosis and treatment.2
     
    Results from a prospective, controlled, randomized, crossover, evaluator-blinded trial demonstrated that FRESCA's CURVE system was non-inferior to CPAP, which is the current gold standard in the treatment of sleep apnea.  Patients treated with the FRESCA system showed significant improvement in baseline values for the Apnea-Hypopnea Index (AHI) and the Oxygen Desaturation Index (ODI), both within the normal range (i.e., AHI 2.9/hr, ODI 1.4/hr). "CPAP compliance continues to be a struggle for millions of people," said the largest enroller in the FRESCA study, Gary Zammit, Ph.D., president & CEO of Clinilabs Inc., Executive Director of the Sleep Disorders Institute in N.Y., and Clinical Associate Professor of Psychiatry at the Icahn School of Medicine at Mount Sinai, N.Y. "Additional options for treating obstructive sleep apnea could ultimately drive improvements in compliance and clinical outcomes."
     
    "FRESCA Medical is committed to developing disruptive and effective technologies for sleep apnea sufferers who cannot tolerate the currently available therapies," said John Cox, president and CEO of FRESCA Medical. "FDA clearance of the CURVE System for obstructive sleep apnea is our first step towards becoming a recognized innovator in sleep apnea.  Our breakthrough technology provides physicians the opportunity to offer a new breathing experience for patients who don't want or cannot tolerate CPAP therapy. Quality sleep is fundamental to good health, and new treatment options are urgently needed in our healthcare armamentarium. This market is already one of the largest applications for cloud-based patient monitoring and engagement, and our goal is to leverage the latest connected health technology to treat, delight and engage patients and providers, while reducing healthcare costs."

    References
    1 Weaver TE, Sawyer AM. Adherence to continuous positive airway pressure treatment for obstructive sleep apnoea: implications for future interventions. Indian J Med Res. 2010;131:245–258.
    2 Watson NF. Health care savings: the economic value of diagnostic and therapeutic care for obstructive sleep apnea. J Clin Sleep Med 2016;12(8):1075–1077.
    Related Searches
    • compliance
    • technology
    • president
    • medical
    Suggested For You
    FDA OKs First Catheter-Based Systems to Create Vascular Access for Hemodialysis Patients FDA OKs First Catheter-Based Systems to Create Vascular Access for Hemodialysis Patients
    FDA Green Lights Trial for RENOVA iStim Tibial Nerve Neuromodulator for Overactive Bladder FDA Green Lights Trial for RENOVA iStim Tibial Nerve Neuromodulator for Overactive Bladder
    Empirical Machine Earns FDA Contract Manufacturer Designation Empirical Machine Earns FDA Contract Manufacturer Designation
    FDA OKs Label Change for Apollo Endosurgery FDA OKs Label Change for Apollo Endosurgery's ORBERA Intragastric Balloon
    FDA Initiates Device Development Challenge to Help Combat Opioid Crisis FDA Initiates Device Development Challenge to Help Combat Opioid Crisis
    3 Critical Considerations for U.S. Medical Device Commercialization 3 Critical Considerations for U.S. Medical Device Commercialization
    FDA Seeks Permanent Injunctions Against Two Stem Cell Clinics FDA Seeks Permanent Injunctions Against Two Stem Cell Clinics
    FDA OKs Cook Medical FDA OKs Cook Medical's Endoscopic Device to Treat GI Bleeding
    Driving Innovation and Improving Quality with 3D Printing Driving Innovation and Improving Quality with 3D Printing
    Quality Nightmares #38: Audit Selection Quality Nightmares #38: Audit Selection
    Software Validation: How It Should Be Done Software Validation: How It Should Be Done
    FDA Authorizes First Test for Emerging Pathogen Candida Auris FDA Authorizes First Test for Emerging Pathogen Candida Auris
    Jan Medical Partners with U.S. Army for Investigational Concussion Diagnosis Device Jan Medical Partners with U.S. Army for Investigational Concussion Diagnosis Device
    23andMe Granted First FDA Authorization for Direct-to-Consumer Cancer Risk Genetic Test 23andMe Granted First FDA Authorization for Direct-to-Consumer Cancer Risk Genetic Test

    Related Breaking News

    • Contract Manufacturing | R&D & Design
      MedStar Health and Cleveland Clinic Innovations Awarded Grant

      MedStar Health and Cleveland Clinic Innovations Awarded Grant

      Cool Idea Award from Protolabs spurs innovation.
      Protolabs 12.12.19

    • 3M to Sell Drug Delivery Business for $650M

      3M to Sell Drug Delivery Business for $650M

      The business, which has annual sales of about $380 million, is being sold to an affiliate of Altaris Capital Partners.
      Business Wire 12.12.19

    • Neurological
      First U.S. Patient Implanted With Axonics

      First U.S. Patient Implanted With Axonics' Sacral Neuromodulation System

      The Axonics r-SNM System is approximately the size of a USB stick and is qualified to operate for at least 15 years.
      Businesswire 12.12.19


    • Cardiovascular
      First U.S. Patients Treated With a Minimally Invasive, Forward Flow Heart Pump

      First U.S. Patients Treated With a Minimally Invasive, Forward Flow Heart Pump

      Impella 5.5 with SmartAssist delivers peak flows of greater than six liters per minute.
      Businesswire 12.12.19

    • Digital Health
      New Pocket Ultrasound Scanners Smaller, More Powerful, and More Affordable

      New Pocket Ultrasound Scanners Smaller, More Powerful, and More Affordable

      Easier to use, second-generation ultra portable wireless scanners give doctors a clearer picture of what's going on.
      PR Newswire 12.12.19

    • Digital Health | Software & IT
      15-Year Tele-Critical Care Collabration Yields Significant ICU Improvement Results

      15-Year Tele-Critical Care Collabration Yields Significant ICU Improvement Results

      Florida’s first eICU, powered by Philips telehealth technology, touts reduced mortality rates and hospital stays for the sickest patients.
      GlobeNewswire 12.11.19


    • 3D/Additive Manufacturing | Software & IT
      Prellis Biologics

      Prellis Biologics' New Tool Simplifies Complex Tissue Engineering

      TissueWorkshop generates complex 3D scaffolds that can be printed with any 3D printing system.
      Krause Taylor Associates 12.11.19

    • InspireMD

      InspireMD's CEO Steps Down

      New CEO Marvin Slosman, a life sciences industry veteran, joins InspireMD from Integra LifeSciences.
      GlobeNewswire 12.11.19

    • Celmatix Sues Research Partner 23andMe for $100M

      Celmatix Sues Research Partner 23andMe for $100M

      Celmatix claims breaches of the parties' agreement and tortious interference with efforts to raise capital.
      PR Newswire 12.11.19


    • FDA Cleared New Cochlear Osia 2 System

      FDA Cleared New Cochlear Osia 2 System

      The world’s first active osseointegrated steady-state implant.
      Cochlear 12.11.19

    • Neurological
      FDA Approves First Nasal Rescue Treatment for Frequent Seizure Activity

      FDA Approves First Nasal Rescue Treatment for Frequent Seizure Activity

      Aptar’s Unidose Liquid System can deliver a formulation in an emergency situation quickly and easily and be administered by a non-healthcare professional.
      Business Wire 12.10.19

    • Diagnostics
      Lens-Free Microendoscope Generates High Quality Images

      Lens-Free Microendoscope Generates High Quality Images

      It also doesn't require movement to focus on objects at different depths.
      Johns Hopkins University 12.10.19

    • Patient Monitoring | Software & IT
      Roche

      Roche's Blood Glucose Reading Smartphone App Gains CE Mark

      The app determines blood glucose ranges by taking photos with the smartphone camera without the need for a blood glucose meter.
      GlobeNewswire 12.10.19

    • FDA BDP Designation for the iLet Bionic Pancreas System

      FDA BDP Designation for the iLet Bionic Pancreas System

      The world’s first fully automated bionic pancreas.
      Beta Bionics 12.10.19

    • Diagnostics
      NeuMoDx Molecular and Sentinel Diagnostics Partner

      NeuMoDx Molecular and Sentinel Diagnostics Partner

      Work together to develop multiple new assays for the NeuMoDx Molecular Systems.
      NeuMoDx Molecular 12.10.19


    Breaking News
    • MedStar Health and Cleveland Clinic Innovations Awarded Grant
    • 3M to Sell Drug Delivery Business for $650M
    • First U.S. Patient Implanted With Axonics' Sacral Neuromodulation System
    • First U.S. Patients Treated With a Minimally Invasive, Forward Flow Heart Pump
    • New Pocket Ultrasound Scanners Smaller, More Powerful, and More Affordable
    View Breaking News >
    CURRENT ISSUE

    November/December 2019

    • Adding Fabrication Capabilities: Additive Manufacturing for Production Parts
    • Delivering the Goods: The Evolving World of Combination Products
    • Anxious Undertones: The 2019 Year in Review
    • View More >
    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Deerland Obtains Certification from Australia’s Therapeutic Goods Administration
    OptiMSM Shown to Improve Hair & Nail Appearance and Condition
    DCC Acquires Contract Manufacturer Ion Laboratories
    Coatings World

    Latest Breaking News From Coatings World

    Arkema: Bostik Acquires Danish Company LIP
    Axalta Adds New Epoxy Primer to Tufcote Liquid Industrial Coatings Portfolio
    Chromaflo Technologies Promotes Sergio Duenas to Country Manager of Mexico
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MedStar Health and Cleveland Clinic Innovations Awarded Grant
    3M to Sell Drug Delivery Business for $650M
    First U.S. Patient Implanted With Axonics' Sacral Neuromodulation System
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Arctoris Opens Oxford R&D Facility
    Almac Group, Exostar Collaborate on IRT Experience
    Northwest Biotherapeutics Expands Management Team
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Time Features 5 Best Beauty Inventions
    CES 2020 Preview - Innovation Award Honorees in Health & Wellness
    Prada & L’Oréal Sign Long-Term Licensing Deal
    Happi

    Latest Breaking News From Happi

    Treasuring Textured Hair
    Pacifica 'Drops' Skin Care Into Ingestible
    Skinnygirl Expands Into Supplements
    Ink World

    Latest Breaking News From Ink World

    Ripon Printers Adds Ricoh Pro C9210
    Canon Solutions America Powers University of Notre Dame Athletics' Printing Capabilities
    Worldwide Large Format Printer Shipments Down Slightly in 3Q 2019: IDC
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    GSE products provide quality assurance for Pharmalabel
    Luminer promotes Heather Bookman to prepress manager
    Materials Exchange launches to solve excess inventory issue
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    DuPont to Acquire Osmosis Specialist
    Nice-Pak to Expand in Indiana
    Hospeco Launches Compact Fem Hy Dispenser
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Europe, North America Comprise More Than 80 Percent of Global Bone Marrow Transplantation Demand
    TriMed Closes Out FDA Warning Letter
    FDA OKs Shoulder Innovations' Augmented Glenoids for Total Shoulder System
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    3D Printing Materials Market to Grow at 23.9% CAGR Through 2025: GVR
    Kyocera, TactoTek Collaborate on Injection Molded Structural Electronics Solutions
    Toray Opens R&D Innovation Center for the Future

    Copyright © 2019 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.