• 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
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    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—May 21

    Iterative Scopes Expands its Senior Leadership Team

    Viz.ai Raises $100 Million in Series D Funding

    FDA Clears Arterys' AI Mapping and Quantification Tools

    Prometheus Group Sued Over Reused Catheters and Rectal Sensors
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Injecting Neurostimulators into Blood Vessels (We Swear, It’s Not Sci-Fi)

    Understanding the Costs of Care in the OR

    Sick of Being Sick: Pandemic Fatigue Flares at AAOS

    Managing Critical Healthcare Supply Chains in Turbulent Times

    To Drive Value, Human Capital Leaders Turn to Outsourced Solutions
    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

    Cirtec Medical

    Concise Engineering

    Trademark Plastics Inc.

    Xact Wire EDM Corp.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3D Printing in Dental Prosthodontics, Orthodontics, and Surgery

    What New Tech Can Improve Your Medical Manufacturing Plant?

    Why Medical Device Firms Must Navigate the Muddy Waters of ESG Requirements

    Medical Device Servicing vs. Remanufacturing

    Digital Marketplaces for Medical Equipment Come of Age
    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

    Cirtec Medical

    Concise Engineering

    Trademark Plastics Inc.

    Xact Wire EDM Corp.
    • 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 Inova Diagnostics' Digital Multi-Analyte System

    The product, Aptiva, received CE marking in August 2020.

    FDA Clears Inova Diagnostics
    The Aptiva System. Image courtesy of PR Newswire.
    Related CONTENT
    • WESTPAK, Inc.
    • BMP Medical - Delivering Custom Plastics Manufactured Solutions
    • Simbex
    • Nissha Medical Technologies
    • Hangsterfer's Laboratories
    PR Newswire09.20.21
    Inova Diagnostics, a worldwide leader in IVD systems and reagents for autoimmune disease in the clinical laboratory, has received U.S. Food and Drug Administration 510(k) clearance for its Aptiva System and Aptiva Celiac Disease IgA assay. Aptiva is a fully automated digital multi-analyte system that represents the next generation of high-throughput processors for the clinical laboratory. Aptiva received CE (Conformité Européenne) marking in August 2020.

    "I am truly excited about the approval of Aptiva," commented Dr. Marcos López Hoyos, head of Immunology Department, Hospital Universitario, Marqués Valdecilla, Cantabria University, Santander, Spain. "It is the fruition of a long-anticipated technology breakthrough and marks a significant step forward to deliver a set of next generation results that will improve the utility of autoimmune diagnostics and provide clinicians reliable test results."
     
    Aptiva addresses many health economic shortcomings in the autoimmune laboratory. Existing systems provide a limited number of analytes that do not reduce the seronegative gap found in many disease states. Beyond the current Celiac assay, Aptiva will include seven additional autoimmune disease states and has over 60 analytes in various stages of advanced development. These additional analytes will help clinicians close the seronegative gap and improve diagnostic confidence.  

    "Aptiva's broad disease and syndromic-based analyte portfolio is a breakthrough that fundamentally enhances the utility of diagnostic testing in the laboratory," said Michael Mahler, Ph.D., vice president of Research and Development at Inova. "Aptiva will bring efficiency and reliability to the autoimmune laboratory and provide expanded information to clinicians for management of patients with autoimmune diseases."
     
    Aptiva also delivers several economic benefits for the laboratory. The 150-sample rack capacity reduces the number of daily interventions and a 6.5-hour consumable walkaway time delivers new levels of workflow efficiencies. Aptiva uses a particle-based multi-analyte technology (PMAT) that processes multiple analytes simultaneously from a patient sample. PMAT enables Aptiva to deliver up to 720 results per hour using a 12-analyte test cartridge and allows the laboratory to complete its workflow in a single shift.  
     
    "Inova Diagnostics is pleased to launch Aptiva in the U.S.," said Roger Ingles, chief operating officer of Inova Diagnostics. "Inova Diagnostics has a 34-year history of providing laboratories with products required for autoimmune diagnosis. Aptiva continues this tradition."
     
    Inova Diagnostics is a privately held company headquartered in San Diego, Calif., and is a part of Werfen, a global leader in IVD with a long-term commitment to providing innovative solutions for hospitals and clinical laboratories to improve patient care. Inova Diagnostics manufactures IVD systems, reagents for autoimmune disease and is a leader in the development and commercialization of new autoimmune technologies and diagnostic markers.  
    Related Searches
    • Diagnostics
    Related Knowledge Center
    • Diagnostics
    Suggested For You
    WESTPAK, Inc. WESTPAK, Inc.
    BMP Medical - Delivering Custom Plastics Manufactured Solutions BMP Medical - Delivering Custom Plastics Manufactured Solutions
    Simbex Simbex
    Nissha Medical Technologies Nissha Medical Technologies
    Hangsterfer Hangsterfer's Laboratories
    IMA Automation North America IMA Automation North America
    Breakthrough Device Designation Granted for New Neuromodulation Platform Breakthrough Device Designation Granted for New Neuromodulation Platform
    Turner Imaging Systems Announces International Expansion Turner Imaging Systems Announces International Expansion
    RedDress’ ActiGraft System Receives New FDA Clearance RedDress’ ActiGraft System Receives New FDA Clearance
    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
    Boston Scientific Agrees to Acquire Devoro Medical Boston Scientific Agrees to Acquire Devoro Medical
    CareDx Appoints Hannah Valantine to its Board CareDx Appoints Hannah Valantine to its Board
    CE Mark Granted to Predictive Software for Kidney Allograft Survival CE Mark Granted to Predictive Software for Kidney Allograft Survival
    Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech

    Related Content

    • WESTPAK, Inc.

      WESTPAK, Inc.

      ...
      Tim Eells, WESTPAK, Inc. 03.04.22

    • BMP Medical - Delivering Custom Plastics Manufactured Solutions

      BMP Medical - Delivering Custom Plastics Manufactured Solutions

      Medical Contract Manufacturing, Design, Assembly & Packaging

    • Simbex

      ...
      Greg Lange, Chief Business Development Officer 11.15.21


    • Nissha Medical Technologies

      ...
      Amy Jeary, Market Development Manager 10.20.21

    • Hangsterfer's Laboratories

      ...
      Mike Ditzel, National Sales Manager 10.11.21


      Trending
      • 5 Ways Plastics Revolutionized The Healthcare Industry | Medical Product Outsourcing
      • The Future Of Biomedical Engineering Advancements | Medical Product Outsourcing
      • Accelerating Product Development In The Age Of Digital Innovation | Medical Product Outsourcing
      • Viz.ai Raises $100 Million In Series D Funding | Medical Product Outsourcing
      • Medical Device Trends To Watch For In 2022 And Beyond | Medical Product Outsourcing
      Breaking News
      • MPO's Most-Read Stories This Week—May 21
      • Iterative Scopes Expands its Senior Leadership Team
      • Viz.ai Raises $100 Million in Series D Funding
      • FDA Clears Arterys' AI Mapping and Quantification Tools
      • Prometheus Group Sued Over Reused Catheters and Rectal Sensors
      View Breaking News >
      CURRENT ISSUE

      May 2022

      • Cybersecurity Challenges Leave Medical Device Makers Insecure
      • Contract Design for Medtech
      • Diabetes Medical Device Technology Update
      • Medtech Full-Service Outsourcing Q&A 2022

      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

      GOED Creates Infographic Highlighting Omega-3 Health Claims Approved in Europe
      Kyowa Hakko Appoints Dr. Colin Hill to Immuse Scientific Advisory Board
      Expert Consensus Statement: Diet is Best Primary Intervention to Achieve Diabetes Remission
      Coatings World

      Latest Breaking News From Coatings World

      What Are You Reading?
      Teknos Receives EcoVadis Gold Medal for Sustainability Performance
      AkzoNobel and Partners Team Up to Hack Carbon Reduction Challenges
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      MPO's Most-Read Stories This Week—May 21
      Iterative Scopes Expands its Senior Leadership Team
      Viz.ai Raises $100 Million in Series D Funding
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Piramal Pharma Solutions New API Plant in Canada Now Online
      MG America Appoints Claudio Radossi as President
      Catalent Invests $175M to Expand Mfg. Capabilities at Winchester, KY
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      Authentic Beauty Concept Launches Second-Generation ‘Refill Bar’
      HASK Beauty Enters Exclusive Partnership with Amazon
      Garance Doré Launches Made in France Skincare Line
      Happi

      Latest Breaking News From Happi

      P&G Closes HQ Due To Security Threat, Launches New Hair Care Line
      SPF Setting Spray, Lip Contour and Knotless Braids Are Hot Trends: Spate
      Nutrafol Launches Collagen Infusion
      Ink World

      Latest Breaking News From Ink World

      Weekly Recap: Zeller+Gmelin, Sun Chemical and Kornit Top This Week’s News
      Nazdar Celebrates 100 Years with a New Look
      hubergroup Chemicals Exhibits at Paint India for First Time
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      Brook + Whittle's new acquisition, SunDance goes to HP and more
      Specialty announces move to new facility
      Mark Andy hosts dealer's open house in Warsaw
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Weekly Recap: Kimberly-Clark to Expand Diaper, Wipes Production in Brazil; The Honest Company to Sell Diapers, Wipes at Walmart & More
      3M to Expand in Nebraska
      Nicely Offers Nonwoven Slitters, Winders
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      ODT's Most Read Stories This Week—May 21
      FDA Clears Anika Therapeutics' X-Twist Knotless Fixation System
      Paragon 28 Rolls Out TenoTac 2.0 Hammertoe and Soft Tissue Repair
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Weekly Recap: Graphene Flagship, Japan Display and LG Display Top This Week’s Stories
      Evonik Launches New Processing Aids for PV Wafer Cutting
      NREL Creates Highest Efficiency 1-Sun Solar Cell

      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