• 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
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    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
    MPO's Most Read Stories This Week—June 25

    Magnetic Insight Announces $17 Million in Series B Funding

    BreatheSuite Adds Brad Fluegel to its Board

    Labcorp Launches At-Home Collection Device for Diabetes Risk Testing

    Thirona, Free Flow Medical Partner on COPD Solutions
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Theranos Fraud Trial, Part II: The Blame Game Continues

    An Update on Surgical Robotics

    Letting the Light In: How Failure Analysis is the Cornerstone of Success

    Three Talent Strategies to Attract High-Demand Skills

    The Advantages of Bioburden Screening for Sterilization Validation
    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
    Arthur G. Russell Co. Inc., The

    Xact Wire EDM Corp.

    Trademark Plastics Inc.

    Concise Engineering

    Cirtec Medical
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    The Power of Leveraging Customer Relationships

    Cost Effective & Efficient Wire EDM Techniques

    How MedTech Professionals Can Help Combat Physician Burnout

    How to Optimize Manufacturing Lines and Choose Which Machines to Buy

    How Are Hypodermic Needles Made?
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Arthur G. Russell Co. Inc., The

    Xact Wire EDM Corp.

    Trademark Plastics Inc.

    Concise Engineering

    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

    Cardiac Insight Announces FDA Clearance of CARDEA SOLO

    Wearable (ECG) sensor gives physicians immediate access to complete cardiac arrhythmia data and analysis.

    Related CONTENT
    • Shockwave Medical Appoints President and CEO
    • FDA Designates N8 Medical's CeraShield Endotracheal Tube as a Breakthrough Device
    • FDA Clears First Whole Slide Imaging System for Digital Pathology
    • Collaborating on Custom Materials Development
    • Extractable/Leachable Chemistry Testing Strategies for Medical Devices
    Business Wire04.26.17
    The U.S. Food and Drug Administration has cleared Cardiac Insight's wearable electrocardiogram (ECG) sensor, CARDEA SOLO. The device offers physicians immediate access to improved reporting and analysis of heartbeat-to-heartbeat data. The design and ease of use also encourage better patient compliance for the acquisition and recording of complete patient data. CARDEA SOLO will be used to assist with the diagnosis of a variety of arrhythmias, including the most common, atrial fibrillation (AFib).
     
    The company expects the capabilities of CARDEA SOLO to enhance efficiencies in mean time to cardiac diagnosis and treatment, which can contribute to improved conditions for patients and reduce health care system costs.
     
    “CARDEA SOLO is an affordable, patient friendly and nonintrusive device designed to improve health care for the millions of patients who suffer from arrhythmia,” said Brad Harlow, co-founder and CEO of Cardiac Insight. “The timely retrieval of cardiac patient data can contribute to improved diagnosis and treatment and lower health care costs.”
     
    Physicians can now use CARDEA SOLO in their offices to retrieve full-disclosure cardiac data for immediate review and action—a process that previously required days or weeks. For the first time, the sensor technology eliminates the need for outsourcing to costly and time-consuming third-party service centers and puts control of the patient data, analysis and processing in the hands of physicians and their staff. Global service billing is streamlined and the need to track and reprocess in-house capital equipment is eliminated.
     
    The device is small, lightweight (approximately 25 grams), lead-less, water-resistant and single-use disposable. Patients can wear CARDEA SOLO comfortably under their clothing for up to seven days and maintain their normal daily activities.
     
    The CARDEA SOLO sensor records ECG data and patient symptoms. The physician office software analyzes the recorded cardiac data to provide physicians with full-disclosure of all data, ECG trace review tools and a summary report of heart rhythms.
     
    The American Heart Association journal, Circulation, reported that 33.5 million people around the globe have AFib. According to the National Stroke Association, AFib raises a person's risk for stroke by 500 percent and most AFib-related strokes can be prevented.
     
    Cardiac Insight is a Kirkland, Wash.-based developer of advanced body-worn digital health care information devices for cardiology, respiratory and other complex disease states. The company’s technologies and systems are created using advanced algorithms and software that provide improvements in mean time to diagnosis. Cardiac Insight’s mission is to invent complete and progressive solutions for unmet clinical needs on behalf of physicians, clients and payers.
    Related Searches
    • ceo
    • track
    • patient
    • technologies
    Suggested For You
    Shockwave Medical Appoints President and CEO Shockwave Medical Appoints President and CEO
    FDA Designates N8 Medical FDA Designates N8 Medical's CeraShield Endotracheal Tube as a Breakthrough Device
    FDA Clears First Whole Slide Imaging System for Digital Pathology FDA Clears First Whole Slide Imaging System for Digital Pathology
    Collaborating on Custom Materials Development Collaborating on Custom Materials Development
    Extractable/Leachable Chemistry Testing Strategies for Medical Devices Extractable/Leachable Chemistry Testing Strategies for Medical Devices
    Four Common Misperceptions of Accelerated FDA Approval Four Common Misperceptions of Accelerated FDA Approval
    FDA Approves Increase in Number of Clinical Sites for E-QURE’s Pivotal Trial of BST Device FDA Approves Increase in Number of Clinical Sites for E-QURE’s Pivotal Trial of BST Device
    VISIOMED’s BewellConnect Launches Presence in Boston VISIOMED’s BewellConnect Launches Presence in Boston
     FlowAid Receives FDA Clearance for the FA100 SCCD FlowAid Receives FDA Clearance for the FA100 SCCD
    Capillus Laser Therapy Caps Receive FDA Clearance for Over-the-Counter Use Capillus Laser Therapy Caps Receive FDA Clearance for Over-the-Counter Use
    FDA Clears Voxello FDA Clears Voxello's Speech Generation Device
    Needless Shocks from Heart Devices Can Trigger Extra Health Costs Needless Shocks from Heart Devices Can Trigger Extra Health Costs
    Reusable ‘Lab on a Chip’ Costs 1 Cent to Make Reusable ‘Lab on a Chip’ Costs 1 Cent to Make
    New Skin Graft System a Better Fix for Chronic Wounds New Skin Graft System a Better Fix for Chronic Wounds
    Check-Cap Begins Trial of Colorectal Cancer-Screening Capsule Check-Cap Begins Trial of Colorectal Cancer-Screening Capsule

    Related Breaking News

    • Cardiovascular
      Shockwave Medical Appoints President and CEO

      Shockwave Medical Appoints President and CEO

      Doug Godshall was most recently the CEO and a director of HeartWare International Inc.
      Business Wire 05.12.17

    • FDA Designates N8 Medical

      FDA Designates N8 Medical's CeraShield Endotracheal Tube as a Breakthrough Device

      Device is a specially-modified endotracheal tube coated with a proprietary ceragenin compound formulation.
      N8 Medical LLC 04.24.17

    • Diagnostics | Digital Health | Electronics | Software & IT
      FDA Clears First Whole Slide Imaging System for Digital Pathology

      FDA Clears First Whole Slide Imaging System for Digital Pathology

      Philips IntelliSite Pathology Solution cleared for primary diagnostic use.
      U.S. Food and Drug Administration 04.13.17


    • Materials | R&D & Design
      Collaborating on Custom Materials Development

      Collaborating on Custom Materials Development

      OEMs and contractors can engage with materials suppliers for custom formulations and product development.
      Deepak Prakash, Vancive Medical Technologies 04.03.17

    • Testing
      Extractable/Leachable Chemistry Testing Strategies for Medical Devices

      Extractable/Leachable Chemistry Testing Strategies for Medical Devices

      ...
      Matthew R Jorgensen, Ph.D., and Thor Rollins, BS, Nelson Laboratories; Allison Komiyama, Ph.D., RAC, AcKnowledge RS 04.03.17

    Loading, Please Wait..

    Trending
    • Intermountain Healthcare & Siemens Healthineers Open 3 Tellica Outpatient Imaging Centers
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Magnetic Insight Announces $17 Million In Series B Funding
    • Thermo Fisher Scientific, Bio-Techne Develop Kidney Rejection Test
    • The Power Of Leveraging Customer Relationships
    Breaking News
    • MPO's Most Read Stories This Week—June 25
    • Magnetic Insight Announces $17 Million in Series B Funding
    • BreatheSuite Adds Brad Fluegel to its Board
    • Labcorp Launches At-Home Collection Device for Diabetes Risk Testing
    • Thirona, Free Flow Medical Partner on COPD Solutions
    View Breaking News >
    CURRENT ISSUE

    June 2022

    • OEMs Seek Molders Offering Timely Techniques
    • Robotic Surgery: Cutting Through to the Latest
    • Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    • 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

    Florida Food Products Acquires Javo
    Roquette Launches Nutralys Rice Protein
    New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy
    Coatings World

    Latest Breaking News From Coatings World

    The Southern Society for Coatings Technology's 84th Annual Technical Conference A Success
    PPG to Showcase Specialty Automotive, Aerospace Adhesives, Sealants at Adhesives & Bonding Expo
    PPG’s New Paint for a New Start Initiative to Transform 25-plus Schools Worldwide
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most Read Stories This Week—June 25
    Magnetic Insight Announces $17 Million in Series B Funding
    BreatheSuite Adds Brad Fluegel to its Board
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Pierre Fabre and Lonza Enter Manufacturing Agreement
    MasterControl and Elemental Machines Form Biomanufacturing Partnership
    Qosina Strengthens Aseptic Capabilities
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Benefit Exec Joins Madison Reed's Board
    Peroni & Ellis Brooklyn Launch Fragrance Collection Inspired by Italian Spritz Cocktails
    Rhode Is Trending for June, Trendalytics Says
    Happi

    Latest Breaking News From Happi

    Spate’s Nose for the Latest Beauty Trends Says The Skunk Stripe, Collagen Serum and Waterproof Eyeshadow are Top of Mind for Consumers this Summer
    A Suitor Emerges for Revlon, SK Capital’s New Dealmaker & P&G’s Indoor Air Quality Efforts
    Wonder Curl Wins GlossWire's GlossPitch Competition
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: INX’s VC Fund, Screen Industry and Ball Top This Week’s News
    British Coatings Federation Posts Online History
    Orion Announces Price Increases, Reduced Payment Terms
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    PCMC teams with IGT, Fujifilm makes big announcement and more
    Loftware recognized as 'AIDC Company of the Year'
    Schreiner MediPharm highlights sustainability of Needle-Trap technology
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Weekly Recap: SWM and Neenah Introduce Mativ Inc., Avgol honored for Biotransformation Technology & More
    Tranzonic Names VP of Supply Chain
    Ontex Climate Action Targets Approved by Science-Based Targets Initiative
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—June 25
    3Spine Inc. Receives IDE Approval for U.S. Pivotal Clinical Trial
    Volume-Based Procurement to Reduce Chinese Orthopedic Market Value
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: eMagin, Applied Materials, and Schott Top This Week’s Stories
    NREL Names Jennifer Logan to Leadership Team as CFO
    National Grid Renewables Orders 2 GW of First Solar Modules

    Copyright © 2022 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