• 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
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    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
    TPI Partners with Zeiss

    PPE Moves into New Manufacturing Facility

    Neurent Medical Closes $25 Million Series B Financing

    Alcon Releases PRECISION1 for Astigmatism Contact Lenses in U.S.

    FDA OKs Canon Medical's AI-Powered, 90cm Bore CT
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    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
    Unicep

    Spectrum Plastics Group

    Element

    Concise Engineering

    FUTEK Advanced Sensor Technology Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Medbio LLC

    Creganna Medical, part of TE Connectivity

    K-Tube Technologies

    Spectrum Plastics Group

    Medicoil
    • 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

    BioSig Announces Successful First-In-Human Use of PURE EP System

    Early results suggest improved cardiac signal detection and fidelity.

    BioSig Announces Successful First-In-Human Use of PURE EP System
    BioSig Technologies' PURE EP System.
    Related CONTENT
    • Alcon Welcomes New CFO
    • J&J Launches Contact Lenses with Transitions Light Intelligent Technology
    • Late-Breaking Analyses from Landmark COAPT Trial Show Benefits of Abbott's MitraClip
    • Abbott's Alinity m Diagnostics System and Assays Gain CE Mark
    • Study: CardioMEMS Sensor Reliably Safe, Cuts Hospitalizations by More than Half
    Globe Newswire04.03.19
    BioSig Technologies Inc., a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the electrophysiology (EP) marketplace, announced that the company successfully conducted first patient cases using PURE EP System, its U.S. Food and Drug Administration (FDA)-approved proprietary signal acquisition and processing technology. The first commercial use of the System was completed at the Texas Cardiac Arrhythmia Institute (TCAI) in Austin, Texas.
     
    The patient studies were conducted by Andrea Natale, M.D., F.A.C.C., F.H.R.S., F.E.S.C., executive medical director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center.

    “With the use of the PURE EP System I was able to identify cardiac signals which were previously undetectable to me. I believe the PURE EP System could change diagnostic and treatment strategies of arrhythmias, leading to more successful outcomes,” commented Dr. Natale.
     
    The PURE EP System was used during the standard studies on patients with persistent atrial fibrillation and conducted in parallel with Abbott’s EnSite Precision and Biosense Webster’s (Johnson & Johnson) CARTO cardiac mapping systems. The goal of the first commercial use of the technology was aimed at validating the System’s key value proposition elements and report on the overall user experience during the procedure.
     
    “We are highly encouraged by the first results reported by Dr. Natale and his team at this facility. A positive first-in-human experience is a major inflection point for our company and lays a strong foundation for our early commercialization efforts,” commented Kenneth L. Londoner, chairman and CEO of BioSig Technologies. “We are well positioned to deliver on our strategic goals for 2019 and look forward to the expansion of our evaluation efforts in the coming months.”
     
    The company released its shareholder letter in February 2019, where it stated its intentions to present the results from the first-in-human studies and the early feedback from the use of the PURE EP System to a larger community of physicians during the Heart Rhythm Society event in May 2019.

    The PURE EP System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. The PURE EP System aims to minimize noise and artifacts and acquire high-fidelity cardiac signals. Improving fidelity of acquired cardiac signals may potentially increase the diagnostic value of these signals, thereby possibly improving accuracy and efficiency of the EP studies and related procedures. The results of pre-clinical studies have been published in a number of journals, including The Journal of Innovations in Cardiac Rhythm Management.

    Located at St. David’s Medical Center in Austin, Texas, the Texas Cardiac Arrhythmia Institute is a recognized training, research and treatment facility dedicated solely to heart rhythm disorders. St. David’s is a state-of-the-science medical center with a medical support staff. Its robotics, magnetics and other advanced technologies complement the expertise of TCAI’s physicians. The Institute brings TCAI’s respected physicians and researchers together with St. David’s superior facilities to address even the most challenging arrhythmias.
     
    BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace. Led by a management team and a veteran Board of Directors, BioSig Technologies is preparing to commercialize its PURE EP System. The technology has been developed to address an unmet need in a large and growing market.
     
    The ompany’s first product, PURE EP System, is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision-making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, atrial fibrillation and ventricular tachycardia. BioSig has partnered with Minnetronix on technology development and has received FDA 510(k) clearance for the PURE EP System in August 2018.
    Related Searches
    • biomedical
    • atrial fibrillation
    • first
    • acquisition
    Suggested For You
    Alcon Welcomes New CFO Alcon Welcomes New CFO
    J&J Launches Contact Lenses with Transitions Light Intelligent Technology J&J Launches Contact Lenses with Transitions Light Intelligent Technology
    Late-Breaking Analyses from Landmark COAPT Trial Show Benefits of Abbott Late-Breaking Analyses from Landmark COAPT Trial Show Benefits of Abbott's MitraClip
    Abbott Abbott's Alinity m Diagnostics System and Assays Gain CE Mark
    Study: CardioMEMS Sensor Reliably Safe, Cuts Hospitalizations by More than Half Study: CardioMEMS Sensor Reliably Safe, Cuts Hospitalizations by More than Half
    FDA Approves Expanded Indication for Abbott FDA Approves Expanded Indication for Abbott's MitraClip
    Abbott Launches Reformulated BinaxNOW Rapid Influenza Test Abbott Launches Reformulated BinaxNOW Rapid Influenza Test
    Electrophysiology Expert Joins BioSig Technologies Management Team Electrophysiology Expert Joins BioSig Technologies Management Team
    FDA Approves Cardiva Medical FDA Approves Cardiva Medical's VASCADE MVP Vascular Closure System for Multi-Site Vessel Closure
    BioSig Technologies To Commence First–in-Human Studies at Mayo Clinic BioSig Technologies To Commence First–in-Human Studies at Mayo Clinic
    Medical Leaders Join BioSig Clinical Advisory Board Medical Leaders Join BioSig Clinical Advisory Board
    BioSig Technologies Announces New Research Program With Mayo Clinic BioSig Technologies Announces New Research Program With Mayo Clinic

    Related Breaking News

    • TPI Partners with Zeiss

      TPI Partners with Zeiss

      Enables TPI to deliver 3D X-Ray Measurement capabilities for Quality Assurance for its clients.
      Charles Sternberg, Assistant Editor 01.21.21

    • Tubing & Extrusion
      PPE Moves into New Manufacturing Facility

      PPE Moves into New Manufacturing Facility

      New building is twice the size of the old one.
      Charles Sternberg, Assistant Editor 01.21.21

    • Neurent Medical Closes $25 Million Series B Financing

      Neurent Medical Closes $25 Million Series B Financing

      Supports the expansion of the company’s clinical and commercial operations.
      Charles Sternberg, Assistant Editor 01.21.21


    • Alcon Releases PRECISION1 for Astigmatism Contact Lenses in U.S.

      Alcon Releases PRECISION1 for Astigmatism Contact Lenses in U.S.

      The daily disposable, silicone hydrogel contact lens for astigmatism will roll out concurrently worldwide beginning in February.
      Sam Brusco, Associate Editor 01.21.21

    • Diagnostics
      FDA OKs Canon Medical

      FDA OKs Canon Medical's AI-Powered, 90cm Bore CT

      Company claims the Aquilion Exceed LB CT offers the industry's largest bore opening.
      Sam Brusco, Associate Editor 01.21.21

    • Molding
      Freudenberg Medical Expands Injection Molding Operations

      Freudenberg Medical Expands Injection Molding Operations

      Adds new machines at its Baldwin Park, California facility.
      Freudenberg Medical 01.21.21


    • Plitek Adds New Slitting Capacity

      Plitek Adds New Slitting Capacity

      Expands its vertically integrated capabilities.
      Plitek 01.21.21

    • FDA Grants Emergency Use Authorization for COVID-19 Rapid Antibody Fingerstick Test

      FDA Grants Emergency Use Authorization for COVID-19 Rapid Antibody Fingerstick Test

      The serology test can be used in point-of-care settings, delivering results in 15-20 minutes.
      Business Wire 01.21.21

    • PhysIQ Elects Former Naval Vice Admiral to its Advisory Board

      PhysIQ Elects Former Naval Vice Admiral to its Advisory Board

      New board member most recently Washington State's medical and healthcare systems response to the COVID-19 pandemic.
      Business Wire 01.21.21


    • Cardiovascular
      First Heart Failure Patient Treated With Impulse Dynamics

      First Heart Failure Patient Treated With Impulse Dynamics' CCM Therapy in Brazil

      The Optimizer delivers cardiac contractility modulation therapy, the company’s proprietary technology, to the heart.
      Business Wire 01.21.21

    • Cardiovascular
      Boston Scientific to Acquire Preventice for Up to $925M

      Boston Scientific to Acquire Preventice for Up to $925M

      Acquisition of external cardiac monitoring technologies, services provider to expand rhythm management diagnostics portfolio.
      PR Newswire 01.21.21

    • Evonik Closes LACTEL Absorbable Polymers Acquisition

      Evonik Closes LACTEL Absorbable Polymers Acquisition

      LACTEL's biodegradable, PLGA-based polymers will be integrated into Evonik’s Health Care business.
      Evonik 01.21.21


    • Eitan Medical Receives FDA Clearance for Sapphire Infusion System

      Eitan Medical Receives FDA Clearance for Sapphire Infusion System

      Upgraded infusion system provides advanced performance and customization capabilities within hospital, pre-hospital and ambulatory environments.
      Eitan Medical 01.20.21

    • Materials
      Researchers Successfully ‘Fine Tune’ New Thermoplastic Biomaterial

      Researchers Successfully ‘Fine Tune’ New Thermoplastic Biomaterial

      Enables both the rate at which it degrades in the body and its mechanical properties to be controlled independently.
      University of Birmingham 01.20.21

    • Diagnostics
      RSIP Vision Announces Versatile Medical Image Segmentation Tool

      RSIP Vision Announces Versatile Medical Image Segmentation Tool

      Delivers efficient anatomical measurements and better treatment options.
      RSIP Visions 01.20.21


    Trending
    • Telemedicine, Regulatory Changes To Characterize Medtech Industry In 2021
    • Masimo Earns CE Mark For New Fingertip Pulse Oximeter
    • Philips Buys Capsule Technologies In $635M Deal
    • Understanding Food-Grade Vs. Biocompatibility For Medical Device Materials
    • Medtech Matters: Surgeons Scrubbing In Virtually
    Breaking News
    • TPI Partners with Zeiss
    • PPE Moves into New Manufacturing Facility
    • Neurent Medical Closes $25 Million Series B Financing
    • Alcon Releases PRECISION1 for Astigmatism Contact Lenses in U.S.
    • FDA OKs Canon Medical's AI-Powered, 90cm Bore CT
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • 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

    NIH Study Compares Low-Fat, Plant-based to Low-Carb, Animal-Based Diet
    Gadot Positions Mineral Line for Vegan Market
    Nutritfy India to Launch Global Broadcast Channel Covering Nutrition
    Coatings World

    Latest Breaking News From Coatings World

    IGL Coatings Launches Graphene Reinforced Dual System Ceramic Coating
    Miller Paint Declares Simple Serenity its 2021 Color of the Year
    TAUBMANS Paint by PPG Releases ‘Chromatic Joy’ Palettes
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    TPI Partners with Zeiss
    PPE Moves into New Manufacturing Facility
    Neurent Medical Closes $25 Million Series B Financing
    Contract Pharma

    Latest Breaking News From Contract Pharma

    WDSrx Expands Warehouse Network
    Piramal Inks Clinical Supply Deal with Theratechnologies
    Recipharm Signs Manufacturing Deal with Enzymatica
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Lageen Tubes Launches Mono-Material PE Tube Solutions
    Jason Jones Loses Battle with Covid-19
    Weleda Celebrates 100 Years By 'Opening' Its Gardens
    Happi

    Latest Breaking News From Happi

    RB Buys Queen V
    NY's 1,4-Dioxane Law May Impact Concentrated Cleaners
    Sabinsa's Top Scientist Addresses US FDA
    Ink World

    Latest Breaking News From Ink World

    Morancé Soudure France Adds Comexi F2 MC 10-color Flexo Press
    THIMM Group Installs 1st Koenig & Bauer CorruFLEX
    Cowan Graphics Adds Fujifilm Inca OnsetX3 HS
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Lemu Group engineers mask-making machine
    Niagara Label upgrades with Nilpeter flexo press
    Soma partners with Moore & Moore in US
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Freudenberg to Establish Apparel Interlining Competence Centers
    Minet Adds Spunlace Line in Romania
    Lemu Group Engineers Mask-Making Machine
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Siemens Healthineers’ DR Systems Cleared by FDA
    Former Medtronic Exec Appointed Zimmer Biomet's Chief Transformation Officer
    SeaSpine Launches Regatta Lateral Plates
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    UDC Subsidiary Adesis' Website Wins 2020 MarCom Platinum Award
    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Graphene Flagship Launches Redesigned Website

    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