• 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
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    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
    January AI Raises $8.8 Million in New Funding

    FDA Clears Ava Fertility Tracking Wearable Device

    First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System

    Artificial Intelligence, Machine Learning Adoption in Healthcare to Grow Considerably

    Japan to Lead APAC Assisted Reproductive Technology Devices Market
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Seeking a Revolution in Clinical Care Through AI

    Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit

    Addition by Subtraction: The Latest of Machining for Medtech

    Innovation Incubators: An R&D Roundtable

    Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Rethink Your Medtech ASC Strategy, Part 1

    Pandemic-Level Playing Field: How COVID-19 Made Space for Progress

    Tips for Reigniting Your MDR/IVDR Preparation

    Three Major Innovation Opportunities for Biomedical Textiles

    Use Vertical Integration to Increase Productivity, Drive Innovation
    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
    Medicoil

    Creganna Medical, part of TE Connectivity

    Medbio LLC

    Qosina Corp.

    FUTEK Advanced Sensor Technology Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Refurbished Medical Equipment Testing and Certification Under the NEC

    Taking the First Step with Metal Components

    4 Trends Driving Medical Manufacturing in 2021

    Pioneering AI Solutions to Reinforce Healthcare Services

    The 8 Major Types of PPE Supply Chain Fraud
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Forefront Medical Technology

    Qosina Corp.

    K-Tube Technologies

    Medbio LLC

    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

    Genetesis' CardioFlux Imaging Tech Gains Breakthrough Status

    Leverages room temperature magnetometers to noninvasively measure heart’s naturally-generated magnetic fields.

    Related CONTENT
    • First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System
    • Japan to Lead APAC Assisted Reproductive Technology Devices Market
    • FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump
    • FDA Approves Daytime Treatment for Sleep Apnea and Snoring
    • FDA Green Lights EPI's EndoClot Hemostat to Manage GI Bleeding
    Business Wire12.16.20
    Genetesis Inc.’s flagship product CardioFlux has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for the diagnosis of myocardial ischemia and infarction in patients with symptoms suggestive of acute coronary syndrome.
     
    CardioFlux, the most advanced commercially available magnetocardiograph (MCG), leverages highly sensitive room temperature magnetometers to deliver noninvasive measurement of the heart’s naturally-generated magnetic fields.
     
    To meet the criteria for Breakthrough Designation, CardioFlux demonstrated the potential for providing a safer, more precise, lower cost, and faster diagnosis for non-ST elevated myocardial infarction (NSTEMI) in the emergency room. Being a completely noninvasive, radiation-free diagnostic scan, requiring no pharmaceuticals or intravenous radioactive contrast agents, the 90-second CardioFlux test represents the most patient-centric solution for health care systems struggling to manage cost and quality of care for cardiac patients.
     
    “We are very pleased with FDA’s vote of confidence that CardioFlux has the potential to meet a significant unmet clinical burden in emergency rooms throughout the country. We are looking forward to working with the Agency in making this groundbreaking technology available to the millions of patients who present with symptoms suggestive of acute coronary syndrome, and to make the patient and clinical experience that much better, safer and affordable as a result,” said Dr. Robert Sokolowski, Vice President of Clinical, Quality and Regulatory Affairs at Genetesis.
     
    The FDA Breakthrough Devices Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA provides interactive and timely communication during device development and throughout the review process. Genetesis looks forward to this accelerated collaborative dialogue with the FDA in the regulatory process leading to commercialization of CardioFlux as a diagnostic modality.
     
    “CardioFlux receiving Breakthrough Device Designation is an important step forward for patients presenting to Emergency Departments across the country with acute chest pain. Chest pain risk stratification continues to be one of our most expensive, radiation intensive, and time-consuming diagnostic burdens in the Emergency Department,” stated Simon A. Mahler, MD MS FACEP, Professor and Director of Clinical Research, Department of Emergency Medicine, Wake Forest School of Medicine. “The rapid approval process combined with reimbursement policy as part of this FDA Pathway will provide immediate access to this safe, noninvasive, and radiation-free diagnostic technology for our patients.”
     
    In 2019, CardioFlux was cleared by FDA for use as a general tool which non-invasively measures and displays the magnetic signals produced by the electric currents of the heart. This clearance heralded the formal entrance of CardioFlux, and the announcement of this Breakthrough Device Designation can be viewed as a key step in enabling magnetocardiography for widespread clinical use, which Genetesis projects will take place in 2021.
    Related Searches
    • Diagnostics
    • Cardiovascular
    Related Knowledge Center
    • Diagnostics
    • Cardiovascular
    Suggested For You
    Medtech Matters: FDA’s Ambiguity on Hyaluronic Acid Medtech Matters: FDA’s Ambiguity on Hyaluronic Acid
    First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System
    Japan to Lead APAC Assisted Reproductive Technology Devices Market Japan to Lead APAC Assisted Reproductive Technology Devices Market
    FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump
    FDA Approves Daytime Treatment for Sleep Apnea and Snoring FDA Approves Daytime Treatment for Sleep Apnea and Snoring
    FDA Green Lights EPI FDA Green Lights EPI's EndoClot Hemostat to Manage GI Bleeding
    Masimo Releases softFlow High-Flow Nasal Cannula Therapy in U.S. Masimo Releases softFlow High-Flow Nasal Cannula Therapy in U.S.
    Rice University Researchers Receive Funding to Develop Covid-19 Sensor System Rice University Researchers Receive Funding to Develop Covid-19 Sensor System
    Bicuspid Aortic Stenosis Treatment to Create Huge Market Potential for TAVR Devices Bicuspid Aortic Stenosis Treatment to Create Huge Market Potential for TAVR Devices
    RDS Completes 3 Million Euros Seed Funding Round RDS Completes 3 Million Euros Seed Funding Round
    Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval
    Pioneering AI Solutions to Reinforce Healthcare Services Pioneering AI Solutions to Reinforce Healthcare Services
    Cerus Endovascular Cerus Endovascular's Contour Neurovascular System Gains Breakthrough Status
    BD Earns EUA, CE Mark for Combo SARS-CoV-2, Influenza A+B Test BD Earns EUA, CE Mark for Combo SARS-CoV-2, Influenza A+B Test
    FDA Clears Rapid Acoustic Pulse Technology for Use in Cellulite FDA Clears Rapid Acoustic Pulse Technology for Use in Cellulite

    Related Breaking News

    • Cardiovascular
      FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump

      FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump

      Puzzle Medical Device's ModulHeart helps patients avoid open-heart surgery and reduces blood trauma.
      Michael Barbella, Managing Editor 02.25.21

    • Cardiovascular
      NTT Research, Japanese Entity to Collaborate on Cardiovascular Disease Interventions

      NTT Research, Japanese Entity to Collaborate on Cardiovascular Disease Interventions

      NCVC in Japan will develop computational models while NTT Research MEI Lab will implement a bio digital twin platform.
      Michael Barbella, Managing Editor 02.24.21

    • Diagnostics
      SpinTech Inc. Acquires MR Innovations

      SpinTech Inc. Acquires MR Innovations

      Includes an expert team of engineers and physicists and MR Innovations' patents, published papers and network of global collaborators.
      Charles Sternberg, Assistant Editor 02.24.21


    • Diagnostics
      Rice University Researchers Receive Funding to Develop Covid-19 Sensor System

      Rice University Researchers Receive Funding to Develop Covid-19 Sensor System

      Real-time electronic system will be able to detect minute amounts of SARS-CoV-2.
      Charles Sternberg, Assistant Editor 02.22.21

    • Diagnostics
      BD Collaborates with Scanwell Health

      BD Collaborates with Scanwell Health

      Aims to create an at-home rapid test for SARS-CoV-2 using a BD antigen test and the Scanwell Health mobile app.
      Charles Sternberg, Assistant Editor 02.22.21

    • Diagnostics
      Study Validates Vocalis Health’s COVID-19 Screening Tool

      Study Validates Vocalis Health’s COVID-19 Screening Tool

      VocalisCheck obtains CE mark approval for medical use.
      Charles Sternberg, Assistant Editor 02.18.21


    • Cardiovascular
      RSIP Vision Announces New Coronary Artery Segmentation Tool

      RSIP Vision Announces New Coronary Artery Segmentation Tool

      New module utilizes deep learning algorithms combined with classic computer vision methods to create a 3D model of the coronary arteries.
      Charles Sternberg, Assistant Editor 02.18.21

    • Cardiovascular
      Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval

      Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval

      Technology approved to treat calcified coronary plaque.
      Charles Sternberg, Assistant Editor 02.17.21

    • Cardiovascular
      Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft Systems

      Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft Systems

      Informs physicians to cease use of the device until further notice.
      Charles Sternberg, Assistant Editor 02.17.21


    • Diagnostics
      Test Identifies COVID-19 Patients at Increased Risk of Intubation With Mechanical Ventilation

      Test Identifies COVID-19 Patients at Increased Risk of Intubation With Mechanical Ventilation

      The assay is currently available in Europe.
      Michael Barbella, Managing Editor 02.16.21

    • Diagnostics
      FDA Grants EUA to Bio-Rad Reliance Assay Kits

      FDA Grants EUA to Bio-Rad Reliance Assay Kits

      Help physicians more easily detect and differentiate SARS-CoV-2 in patients.
      Charles Sternberg, Assistant Editor 02.16.21

    • Diagnostics
      Suitcase Laboratory to Detect COVID-19 in Development

      Suitcase Laboratory to Detect COVID-19 in Development

      Mobile laboratory for rapid detection of SARS-CoV-2 for Africa.
      Sam Brusco, Associate Editor 02.12.21


    • Cardiovascular | Neurological
      Cerus Endovascular

      Cerus Endovascular's Contour Neurovascular System Gains Breakthrough Status

      Indicated for the treatment of intracranial aneurysms.
      Sam Brusco, Associate Editor 02.12.21

    • Diagnostics
      BD Earns EUA, CE Mark for Combo SARS-CoV-2, Influenza A+B Test

      BD Earns EUA, CE Mark for Combo SARS-CoV-2, Influenza A+B Test

      Also shows ability to detect U.K., South African variants of COVID-19.
      Sam Brusco, Associate Editor 02.12.21

    • Diagnostics
      ProPhase Labs Begins Saliva-Based, Viral RT-PCR Multiplex-Testing

      ProPhase Labs Begins Saliva-Based, Viral RT-PCR Multiplex-Testing

      System can be used for COVID-19, Influenza A & B, and other viruses.
      Charles Sternberg, Assistant Editor 02.09.21


    Trending
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Hardy Diagnostics Releases Rapid Test For COVID-19
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • FDA Breakthrough Device Designation Given To MI Transcatheter Heart Pump
    • Refurbished Medical Equipment Testing And Certification Under The NEC
    Breaking News
    • January AI Raises $8.8 Million in New Funding
    • FDA Clears Ava Fertility Tracking Wearable Device
    • First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System
    • Artificial Intelligence, Machine Learning Adoption in Healthcare to Grow Considerably
    • Japan to Lead APAC Assisted Reproductive Technology Devices Market
    View Breaking News >
    CURRENT ISSUE

    January/February 2021

    • Seeking a Revolution in Clinical Care Through AI
    • Diversifying Supply Chains: New Opportunities Post Pandemic and After Brexit
    • Addition by Subtraction: The Latest of Machining for Medtech
    • Innovation Incubators: An R&D Roundtable
    • Virtual Allies: Electronics Manufacturing Services Providers Offer Real Solutions
    • 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

    Preliminary Study Links Markers of Impaired Bone Health to Vegan Diet
    Refined Grains Linked to Heart Attack Risk, Early Death
    Kappa Bioscience Extends Research Partnership For COVID-19 Research
    Coatings World

    Latest Breaking News From Coatings World

    Nippon Paint Marine Wins Korea Export Award
    Universal Display Corporation, PPG Expand Global Production of UniversalPHOLED Materials
    PPG Introduces Premium Iso-free Primer Surfacer, Catalyst
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    January AI Raises $8.8 Million in New Funding
    FDA Clears Ava Fertility Tracking Wearable Device
    First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Spark Therapeutics Appoints CTO
    Cryoport Launches ESG Program
    U.S. Govt. Purchases 100k Doses of Lilly's COVID-19 Antibody Cocktail
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    The Top Beauty Products of 2021, According to HelloGiggles
    Estée Lauder Taps Ana de Armas as Global Brand Ambassador
    Sephora Announces Significant Expansion
    Happi

    Latest Breaking News From Happi

    What You're Reading on Happi.com
    Cosmetic Chemical Sales To Post CAGR 5.8% To 2025
    ACI Urges Senate to Approve Regan as EPA Administrator
    Ink World

    Latest Breaking News From Ink World

    Etiflex Enters New Markets with Nilpeter FA-22 Installation
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Marshall & Bruce Adds Koenig & Bauer Rapida 106 41-Inch Seven-Color Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    FTA converts Forum & INFOFLEX to virtual events
    Xeikon launches two new digital label printing presses
    UFlex adds capacity in packaging films
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Texas Medical Technology Partners with My Protect Kit
    Mexico City Single-Use Plastics Ban Leads to Tampon Shortage
    Believe Diapers Launch in U.S.
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Fusion Robotics Receives FDA Clearance for Spinal Navigation and Robotics System
    Kaia Health Unveils Next-Gen Complete MSK Care Solutions
    First Implantation of CTL Amedica's Minimally Invasive Flex Tower
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    Global Smart Glass Market to Register 6.8% CAGR Between 2021-28: Grand View Research

    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