• 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
    Transporting Treatment: An Examination of Tubing Technologies

    Outward Appearance: Reviewing Surface Treatment Options

    Face to (Virtual) Face: Telemedicine Now and Post-Pandemic

    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform
    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
    Top News
    FDA Grants 510(k) Clearance to LivaNova’s B-Capta

    Gynesonics Appoints Susan Stimson to Its Board of Directors

    Piezo Motion Debuts Piezoelectric Micro-Dosing Pump

    Riva Health Raises $15.5 Million for Breakthrough Mobile Cardiology Technology

    Abbott Begins Shipping Rapid COVID Self-Tests
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Transporting Treatment: An Examination of Tubing Technologies

    Outward Appearance: Reviewing Surface Treatment Options

    Face to (Virtual) Face: Telemedicine Now and Post-Pandemic

    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Home Is Where the Heart (Valve) Is

    CGM: Digital Health Meets a Very Large Opportunity

    Biomechanical Engineer, Heal Thyself

    Optimizing MIM in Medical Device Manufacturing

    PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market
    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
    PTI Engineered Plastics Inc.

    MW Life Sciences

    Medicoil

    Forefront Medical Technology

    Spectrum Plastics Group
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    EMS' Engineering Resources Increasingly in Demand

    Fiber Optics Introducing New Cleanliness Requirements for Medical Electronics

    EMS Providers Valued for Product Customization, Medical Certification Expertise

    Three Future Trends and Opportunities in Quality Assurance

    Adopting a Data-Driven Quality Model
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    FUTEK Advanced Sensor Technology Inc.

    Unicep

    maxon

    Qosina Corp.

    Creganna Medical, part of TE Connectivity
    • 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
    • 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

    FDA Clears Bardy Diagnostics' 14-Day Carnation Ambulatory Monitor Patch

    The patch detects and records the P-wave, a small amplitude signal of the ECG originating in the atrium that is essential to accurate arrhythmia diagnosis.

    FDA Clears Bardy Diagnostics
    Bardy Diagnostics' Carnation Ambulatory Monitor 14-day version. Image courtesy of Bardy Diagnostics Inc..
    Related CONTENT
    • Forefront Medical Technology
    • CRM Device Demand Soars Amid Surging Cardiovascular Disease Prevalence
    • Echosens Appoints Group CEO
    • FDA Encourages Patient Engagement in Medical Device Clinical Investigations
    • FDA Publishes 4 Draft Guidances in Continuing Effort to Modernize 510(k)
    PR Newswire10.21.19
    Bardy Diagnostics Inc., a provider of ambulatory cardiac monitoring technologies and custom data solutions, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the 14-Day version of the Carnation Ambulatory Monitor (CAM), the industry's only P-wave centric ambulatory cardiac patch monitor and arrhythmia detection device. Developed to provide clinicians greater flexibility in cardiac monitoring over a longer period, the CAM patch will now be offered in a 14-day extended wear version that utilizes the same innovative P-wave focused technology that powers the existing two-Day and seven-Day CAM product lines.
     
    "Comfortable dermal ECG recordings that focus on the P-wave for up to 14 days carry the potential to minimize use of costly additional rhythm diagnostic tools," said Gust H. Bardy, M.D., founder and CEO of BardyDx. "We are excited to receive clearance from the FDA to enable clinicians the option to monitor longer and anticipate incremental detection of accurate, medically actionable data to improve patient management."
     
    The CAM patch's breakthrough technology reliably detects and records the P-wave, a small amplitude signal of the ECG originating in the atrium that is essential to accurate arrhythmia diagnosis and patient management. Unlike other commercially available patches that include licensed, acquired, or off-the-shelf technologies, the CAM was specially engineered by BardyDx engineers for optimal detection and recording of the P-wave in relation to the rest of the ECG signal to deliver industry leading diagnostic accuracy. The critically acclaimed disruptive technology has been well-received by clinicians, particularly for its ease of use and workflow-friendly design, which allows patients to mail the device back for analysis or the physician office to upload data from a patient's monitor within several minutes upon completion of a study.
     
    The new 14-Day CAM patch enables up to double the duration of P-wave optimized detection and monitoring over the current seven-Day CAM patch, potentially discovering additional, less-frequent arrhythmias. The clinical value of P-wave focused detection was highlighted in the American Heart Journal that published the results of a head-to-head comparison with the iRhythm Zio XT patch. The study, "Comparison of two ambulatory patch ECG monitors: The benefit of the P-wave and signal clarity," (Am Heart J 2018; 203:109-117) concluded that the BardyDx CAM patch identified 40 percent more arrhythmias and resulted in better, more informed clinical decision-making in 41 percent of patients compared to the iRhythm Zio XT patch. 
     
    In addition, a preceding study comparing the BardyDx CAM patch and a traditional Holter monitor, entitled "Comparison of diagnostic value using a small, single channel, P-wave centric sternal ECG monitoring patch with a standard 3-lead Holter system over 24 hours," (Am Heart J 2017; 185:65-73) showed a four times increase in arrhythmia detection using the CAM patch, including arrhythmias missed or incorrectly identified using the Holter monitor. The study concluded that the CAM patch offered significantly improved rhythm diagnosis and avoided inaccurate diagnoses made using a Holter monitor.
     
    "Combining the excellence of our P-wave technology with the capability of longer duration monitoring produces an unmatched cardiac monitoring solution," said Ken Nelson, BardyDx chief commercial officer. "We are excited to offer a 14-Day CAM patch that truly provides value for clinicians and patients alike."
     
    Bardy Diagnostics Inc. is an innovator in digital health and remote patient monitoring, with a focus on providing the most diagnostically-accurate and patient-friendly cardiac patch monitors to the industry. The company's CAM patch is a non-invasive, P-wave centric ambulatory cardiac monitor and arrhythmia detection device that is designed to improve patient compliance for adults and children through its lifestyle-enabling design. Designed to be worn comfortably and discreetly, the female-friendly, hourglass-shaped CAM patch is placed on the center of the chest, directly over the heart for optimum ECG signal collection. The proprietary technology of the CAM patch provides optimal detection and clear recording of the often difficult-to-detect P-wave, the signal of the ECG waveform that is essential for accurate arrhythmia diagnosis.
     
     
    Related Searches
    • patch
    • ceo
    • cardiac
    • diagnostics
    Suggested For You
    Forefront Medical Technology Forefront Medical Technology
    CRM Device Demand Soars Amid Surging Cardiovascular Disease Prevalence CRM Device Demand Soars Amid Surging Cardiovascular Disease Prevalence
    Echosens Appoints Group CEO Echosens Appoints Group CEO
    FDA Encourages Patient Engagement in Medical Device Clinical Investigations FDA Encourages Patient Engagement in Medical Device Clinical Investigations
    FDA Publishes 4 Draft Guidances in Continuing Effort to Modernize 510(k) FDA Publishes 4 Draft Guidances in Continuing Effort to Modernize 510(k)
    FDA Advises Transition to Disposable Duodenoscopes FDA Advises Transition to Disposable Duodenoscopes
    AlloSure for Heart Transplant Patients Receives CMS Draft Coverage AlloSure for Heart Transplant Patients Receives CMS Draft Coverage
    Abbott Recalls Ellipse ICDs Abbott Recalls Ellipse ICDs
    Philips Buys Boston-Based Patient Navigation Startup Medumo Philips Buys Boston-Based Patient Navigation Startup Medumo
    Development in Biliary Disease Technology to Renew Global Interest in Pancreatic & Biliary Stents Development in Biliary Disease Technology to Renew Global Interest in Pancreatic & Biliary Stents
    FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting FDA Shares Progress on Efforts to Increase Transparency in Medical Device Reporting
    FDA Approves Philips FDA Approves Philips' HeartStart OnSite and HeartStart Home Defibrillators
    Connected Quality Systems Reduce Risks Connected Quality Systems Reduce Risks
    FDA OKs Leica Biosystems FDA OKs Leica Biosystems' Digital Pathology System for Primary Diagnosis
    FDA OKs ControlRad FDA OKs ControlRad's Radiation Reduction Technology that Integrates into Mobile C-arms

    Related Breaking News

    • Patient Monitoring
      FDA Grants 510(k) Clearance to LivaNova’s B-Capta

      FDA Grants 510(k) Clearance to LivaNova’s B-Capta

      An in-line, blood-gas monitoring system integrated into the S5 Heart-Lung Machine.
      Charles Sternberg, Assistant Editor 04.20.21

    • Gynesonics Appoints Susan Stimson to Its Board of Directors

      Gynesonics Appoints Susan Stimson to Its Board of Directors

      Executive with extensive commercialization experience to provide key insights on global launch strategies.
      Michael Barbella, Managing Editor 04.20.21

    • Piezo Motion Debuts Piezoelectric Micro-Dosing Pump

      Piezo Motion Debuts Piezoelectric Micro-Dosing Pump

      Applications that traditionally require two or three separate laboratory devices can now be replaced with a single micro-dosing pump.
      Michael Barbella, Managing Editor 04.20.21


    • Cardiovascular
      Riva Health Raises $15.5 Million for Breakthrough Mobile Cardiology Technology

      Riva Health Raises $15.5 Million for Breakthrough Mobile Cardiology Technology

      Menlo Ventures, UCHealth invest to bring comprehensive hypertension measurement and management to the phone.
      Michael Barbella, Managing Editor 04.20.21

    • Diagnostics
      Abbott Begins Shipping Rapid COVID Self-Tests

      Abbott Begins Shipping Rapid COVID Self-Tests

      Abbott to manufacture tens of millions of BinaxNOW Self Tests per month.
      Sam Brusco, Associate Editor 04.20.21

    • Cardiovascular
      FDA OKs Canon Medical

      FDA OKs Canon Medical's One-Beat Spectral Cardiac CT

      Aquilion ONE / PRISM Edition now offers AI-powered spectral capabilities for cardiac exams.
      Sam Brusco, Associate Editor 04.19.21


    • NeuroLogica Debuts Next-Generation SmartMSU with OmniTom Elite

      NeuroLogica Debuts Next-Generation SmartMSU with OmniTom Elite

      Mobile Stroke Unit includes new CT scanner and features that help EMTs improve patient care.
      Michael Barbella, Managing Editor 04.19.21

    • IZI Medical Products Launches Fully Automatic Quick-Core Auto Biopsy System

      IZI Medical Products Launches Fully Automatic Quick-Core Auto Biopsy System

      Product has three programmable firing modes for tissue sampling.
      Michael Barbella, Managing Editor 04.19.21

    • Seed Grants Awarded to Five Proposals for Pediatric Medical Device Development

      Seed Grants Awarded to Five Proposals for Pediatric Medical Device Development

      Projects address infant feeding development, neonatal jaundice, pediatric dysphagia, unplanned extubations, and adrenal crisis.
      Michael Barbella, Managing Editor 04.19.21


    • Iterative Scopes Announces IBD-Focused Scientific Advisory Board

      Iterative Scopes Announces IBD-Focused Scientific Advisory Board

      The governing body also will include experts in artificial intelligence.
      Michael Barbella, Managing Editor 04.16.21

    • Vicarious Surgical, D8 Holdings Corp. Combine Operations in $1.1 Billion Deal

      Vicarious Surgical, D8 Holdings Corp. Combine Operations in $1.1 Billion Deal

      Transaction is expected to foster the development of Vicarious Surgical's flagship robot and establish a foundation for long-term growth.
      Michael Barbella, Managing Editor 04.16.21

    • Diagnostics
      FDA Grants De Novo Clearance to Medtronic’s GI Genius Model

      FDA Grants De Novo Clearance to Medtronic’s GI Genius Model

      Assists physicians in detecting pre-cancerous growths, potentially addressing 19 million colonoscopies annually.
      Charles Sternberg, Assistant Editor 04.15.21


    • Acutus Medical Receives FDA Clearance of AcQCross

      Acutus Medical Receives FDA Clearance of AcQCross

      Product family targets more than 300,000 annual U.S. electrophysiology and structural heart procedures.
      Michael Barbella, Managing Editor 04.15.21

    • Thermo Fisher Scientific to Acquire PPD for $17.4 Billion

      Thermo Fisher Scientific to Acquire PPD for $17.4 Billion

      The deal establishes Thermo Fisher as a global leader in the high-growth clinical research services industry.
      Michael Barbella, Managing Editor 04.15.21

    • Portable Medical Devices Market to Reach $100 Billion by 2027

      Portable Medical Devices Market to Reach $100 Billion by 2027

      Sector to grow 8.5 percent annually over the next six years, driven by an increased awareness of overall health and fitness.
      Michael Barbella, Managing Editor 04.15.21


    Trending
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Survey: Remote Patient Monitoring To Match Or Surpass In-Patient Within Five Years
    • Harnessing Critical Health Data With Wearable Technology
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Device Designed To Permanently Replace Failing Human Hearts
    Breaking News
    • FDA Grants 510(k) Clearance to LivaNova’s B-Capta
    • Gynesonics Appoints Susan Stimson to Its Board of Directors
    • Piezo Motion Debuts Piezoelectric Micro-Dosing Pump
    • Riva Health Raises $15.5 Million for Breakthrough Mobile Cardiology Technology
    • Abbott Begins Shipping Rapid COVID Self-Tests
    View Breaking News >
    CURRENT ISSUE

    April 2021

    • Transporting Treatment: An Examination of Tubing Technologies
    • Face to (Virtual) Face: Telemedicine Now and Post-Pandemic
    • Outward Appearance: Reviewing Surface Treatment Options
    • 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

    Longvida Curcumin Extract Receives ANVISA Approval in Brazil
    Curcugen Curcumin Formulation Evidenced to Attenuate Post-Exercise Inflammation
    Good Rāz Launches Taste-Free Vitamin D3 Drops
    Coatings World

    Latest Breaking News From Coatings World

    USGBC Releases Results of 2021 Green Building Community Survey
    PPG Publishes Sustainability Report
    Sherwin-Williams Launches Echelon
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    FDA Grants 510(k) Clearance to LivaNova’s B-Capta
    Gynesonics Appoints Susan Stimson to Its Board of Directors
    Piezo Motion Debuts Piezoelectric Micro-Dosing Pump
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Evotec to Build Second Biologics Mfg. Facility in Toulouse
    Adare Pharma Names Ludger Roedder President of Adare Biome
    Johnson & Johnson 1Q Results
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Donginbi Launches Men’s Skincare Collection
    Kiehl’s Launches Pouch Refillables
    Skin Match Technology Partners with Men-Only Grooming Platforms
    Happi

    Latest Breaking News From Happi

    Robertet Appoints Reichert as Perfumer
    Kiehl’s Launches Sustainable Pouch Refillables for Hair Care, Skin Care
    New OTC Natural Hemp Pain Relief Gel Arrives at cbdMD
    Ink World

    Latest Breaking News From Ink World

    Kumon North America Adds Speedmaster XL 106 from Heidelberg
    SE-DA Invests in Kornit Presto S
    Acrylic Resins Market Worth $21.9 Billion by 2025: MarketsandMarkets
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    PPG releases 2020 Sustainability Report
    GAA merges with AIMCAL
    Acucote expands Insights educational program
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Glatfelter GlatClean Nominated for World of Wipes Innovation Award
    P&G’s Sales Up 5%
    Ontex Tests Industrial Scale Diaper Composting
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    SeaSpine Begins Limited Rollout of WaveForm TO 3D-Printed Interbodies
    Spinal Elements' Lucent 3D Additive Manufactured Interbodies Earn FDA Nod
    Conformis, Paragon 28 Ink Licensing Deal
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    SEMI Appoints imec, Soitec Executives to Europe Advisory Board
    NREL Takes Novel Approach to 3D-Printed Water Power Prototypes
    Canatu Manufactures World’s Thinnest Free-standing CNB Membrane

    Copyright © 2021 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