• 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 Medtech Supply Chain Survey

    Exceeding Medical Device Extrusion Expectations

    Medical Device Micromolders Discuss the 'Minor Details'

    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends
    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
    3D Systems Partners with Klarity to Expand Distribution of VSP Bolus Solution

    Zeus Introduces Absorv XSE Oriented Tubing

    Laminate's VasQ Nabs De Novo Nod to Create AVFs for Dialysis Access

    Varian Buys Aspekt Solutions to Bolster Advanced Oncology Biz

    Patient Enrollment Ends in Biosense Webster's SmartfIRE Study
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    MPO's 2023 Medtech Supply Chain Survey

    Exceeding Medical Device Extrusion Expectations

    Medical Device Micromolders Discuss the 'Minor Details'

    Superior Subtractive Solutions for Machining Medtech

    Assembly & Automation Experts Share Thoughts on Medtech Trends
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Back to School for Medical Device Cybersecurity Training

    Driving Clinical Trial Excellence to Help Study Teams Run a Faster Relay Race

    Medtech’s Supply Chain: From Disruption to Opportunity

    Are Medtech’s Mega-Deals Gone For Good?

    Will a Skilling Gap Hinder Organizational Readiness for Medtech’s New Age of AI?
    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
    LEMO USA Inc.

    Medbio LLC

    Halkey-Roberts Corporation

    Johari Digital Healthcare Ltd.

    Providence Enterprise USA Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Wearables Are Changing the Way We Collect Real-World Data in Clinical Trials

    Could Medtech Ever Stop a Hospital Killer in Their Tracks?

    A One-Stop-Shop, Turnkey Solution Is Paramount for Success

    How Additive and Subtractive Manufacturing Are Revolutionizing the Medical Device Industry

    Medical Device Commercialization: It’s What, Not When, to Transfer to Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    LEMO USA Inc.

    Medbio LLC

    Halkey-Roberts Corporation

    Johari Digital Healthcare Ltd.

    Providence Enterprise USA Inc.
    • 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 Clears B-Secur's HeartKey EKG/ECG Technology

    The product's algorithms can be quickly integrated in semiconductors for devices in the medtech, health monitoring, and wellness sectors.

    Michael Barbella, Managing Editor02.19.21
    The U.S. Food and Drug Administration (FDA) has greenlighted software that generates data encrypted through a patient's heartbeat.

    B-Secur's HeartKey software library1 is a suite of powerful EKG/ECG algorithms that combine user identification, health, and wellness to generate accurate data encrypted through the user’s heartbeat, which can now be implemented across devices in home or healthcare environments, with the ability to run embedded on device, on the application layer and even via the cloud.

    “The inspiration around EKG/ECG and HeartKey is being able to take biometrics to the next level, enabling the development of trusted biosensing technology,” Alan Foreman, CEO at B-Secur said. “With HeartKey, EKG/ECG is used to determine who you are and how you are at the same time, and can help protect lives, data, and devices. With heart disease being the world’s single biggest killer, we are perfectly positioned to help save lives.”
     
    The FDA-cleared HeartKey algorithms can be quickly and easily integrated in semiconductors for a broad range of devices in the consumer wellness, health monitoring and medical technology sectors, enabling rapid integration of medical-grade EKG/ECG software with those devices. It also provides the potential for all leading technology device manufacturers and healthcare service providers to generate advanced medical-grade wellness and health data from any device and platform.
     
    This significant development from B-Secur comes at an important time for cardiovascular disease (CVD), which is the leading cause of death globally with an estimated 17.9 million people dying from the disease each year, representing 31 percent of all global deaths.2
     
    Last year, the COVID-19 pandemic led to additional health complications for those with underlying heart conditions. The virus has also caused irreparable cardiac damage and arrhythmias in people with no underlying heart issues, making heart health and remote monitoring a key priority for patients, clinicians and health service providers around the world. Developed and optimized for everyday devices, HeartKey provides the ultimate flexibility in integration, truly enabling “EKG/ECG Everywhere.”
     
    Dr. Andrew Mitchell, a consultant cardiologist at Jersey General Hospital and Honorary Consultant Cardiologist at the John Radcliffe Hospital in Oxford, United Kingdom, welcomed the development commenting, “It is excellent and very timely to hear that B-Secur has received FDA clearance for its HeartKey library. Heart rhythm conditions affect one in four adults, yet many have no awareness that they have a problem that could lead to stroke or heart failure. With the increasing availability of wearable and IoT devices, FDA-cleared solutions like HeartKey give patients and their doctors additional tools to detect these rhythms early.”
     
    “HeartKey has been developed to enable scalability of medical grade EKG/ECG across IoT devices, and the award of FDA clearance is testament to HeartKey’s performance and the very talented team behind it,” Adrian Condon, chief technology officer at B-Secur, added. “This clearance should significantly aid our partners and customers increase the speed to market for their technology.”
     
    FDA clearance has been granted for the following EKG/ECG feature algorithms: Signal Conditioning, Heart Rate and Arrhythmia Analysis. The HeartKey Arrhythmia Analysis algorithm currently includes Atrial Fibrillation, Bradycardia and Tachycardia. As a lot of arrhythmias are typically transient, they are difficult to catch in hospital. With 33 million people experiencing atrial fibrillation worldwide, HeartKey’s FDA-cleared algorithms can support in the detection and management of arrhythmias outside of the traditional hospital environment, allowing clinicians to make more accurate clinical decisions based on larger amounts of data.
     
    FDA clearance of the HeartKey software library ensures B-Secur customers and partners can have confidence in its world-leading algorithm performance and accuracy. The fully validated, turnkey solution with FDA clearance will ease integration—reducing development time and costs as well as driving speed to market for end devices.

    References 
    1 Access to U.S. Food and Drug Administration (FDA) HeartKey® clearance details for software library K200884.pdf
    2 World Health Organisation, https://www.who.int/en/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)
     
     
    Suggested For You
    NTK Cutting Tools USA NTK Cutting Tools USA
    Nissha Medical Technologies Nissha Medical Technologies
    JK Medirise-Disposable Medical Device Company JK Medirise-Disposable Medical Device Company
    Critical Software Solutions Critical Software Solutions
    sfm medical devices GmbH sfm medical devices GmbH
    Heraeus Medevio Heraeus Medevio
    Simbex Simbex
    BMP Medical - Delivering Custom Plastics Manufactured Solutions BMP Medical - Delivering Custom Plastics Manufactured Solutions
    High Tech Turning Co. Inc. High Tech Turning Co. Inc.
    Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles
    Accu-Tube Appoints Matthew Haddle as CEO Accu-Tube Appoints Matthew Haddle as CEO
    Turner Imaging Systems Announces International Expansion Turner Imaging Systems Announces International Expansion
    Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings
    MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021 MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021
    Olympus Corporation Launches Powerseal Advanced Bipolar Surgical Energy Products Olympus Corporation Launches Powerseal Advanced Bipolar Surgical Energy Products

    Related Buyers Guide Companies

    • NTK Cutting Tools USA

      ...
      Melissa Singher, Senior Product Coordinator 11.18.22

    • Nissha Medical Technologies

      ...
      Amy Jeary, Market Development Manager 11.18.22

    • JK Medirise-Disposable Medical Device Company

      ...
      Ketan Munjani, Marketing Manager 11.17.22


    • Critical Software Solutions

      ...
      Allen Curtis, CTO 11.16.22

    • sfm medical devices GmbH

      ...
      Albert Busch, Head of Marketing 11.11.22

    Loading, Please Wait..

    Trending
    • Cardiosense Begins SEISMIC-HF I Heart Failure Trial
    • Danaher Names New Environmental And Applied Solutions Company Veralto
    • Exo Introduces The Exo Iris To Market
    • A New Approach To Post-Market Surveillance
    • Varian Buys Aspekt Solutions To Bolster Advanced Oncology Biz
    Breaking News
    • 3D Systems Partners with Klarity to Expand Distribution of VSP Bolus Solution
    • Zeus Introduces Absorv XSE Oriented Tubing
    • Laminate's VasQ Nabs De Novo Nod to Create AVFs for Dialysis Access
    • Varian Buys Aspekt Solutions to Bolster Advanced Oncology Biz
    • Patient Enrollment Ends in Biosense Webster's SmartfIRE Study
    View Breaking News >
    CURRENT ISSUE

    October 2023

    • MPO's 2023 Medtech Supply Chain Survey
    • Exceeding Medical Device Extrusion Expectations
    • Medical Device Micromolders Discuss the 'Minor Details'
    • 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

    PLT Health Solutions Granted Claims for Botanical Ingredient in Canada
    CRN Files Petition with FTC For Clarity on Health Products Compliance Guidance
    Vitafoods Europe Relocates to Barcelona Starting 2025
    Coatings World

    Latest Breaking News From Coatings World

    IGL Coatings Partners with DHL Express
    Micro Powders Showcases Natural, PTFE Alternative Additives at 2023 WCS
    U.S. Green Building Council and RMI Release Report to Drive Action on Embodied Carbon in Buildings
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    3D Systems Partners with Klarity to Expand Distribution of VSP Bolus Solution
    Zeus Introduces Absorv XSE Oriented Tubing
    Laminate's VasQ Nabs De Novo Nod to Create AVFs for Dialysis Access
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Ono, Admid Partner on Novel Antibody Drugs in Oncology
    Theradaptive Awarded DOD Clinical Trial Award of up to $7.4M
    Ginkgo Bioworks, Pfizer Enter Multi-Target RNA Discovery Alliance
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    NYX Professional Makeup Partners with the New York Liberty
    BASF and StitchCrew Introduce Educational Bootcamp for Indigenous Beauty Brands
    Top 10 Most Popular Fashion Designer Makeup Brands—According to Landys Chemist
    Happi

    Latest Breaking News From Happi

    Micro Powders Appoints IMCD US New Regional Distributor for Personal Care Products
    American Cleaning Institute Praises Draft Proposal on Cleaning Product Ingredient Transparency
    NYX Professional Makeup Inks First Partnership with The New York Liberty
    Ink World

    Latest Breaking News From Ink World

    Micro Powders Showcases New Natural, PTFE Alternative Additives at 2023 WCS
    Roland DG Direct-To-Film Printer Ink, Powder Receive ECO PASSPORT Certification
    INX Will Show Inkjet, Sustainable Packaging Solutions at PRINTING United
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    INX brings inkjet and sustainable packaging to PRINTING United Expo
    Schreiner MediPharm introduces Freeze-Light-Protect syringe label
    Kodak launches PRINERGY 10.0
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    ExxonMobil Works with JL Goor to Help Drive Growth in Ireland and U.K. Healthcare Sector
    Lee C. Stewart Resigns from Glatfelter Board
    Ana Fraisse Joins The American Cleaning Institute
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    CTL Amedica Granted ECAT Approval from Defense Logistics Agency
    Intech Acquires Lenkbar LLC
    ONWARD Completes First-in-Human for ARC-IM to Restore Upper Extremity Function
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Jabil Announces Definitive Agreement to Divest Mobility Business for $2.2B
    PPG and Flō-Optics Enter Exclusive Supplier Agreement
    SEMI North America Advisory Board Adds New Members

    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