• 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
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    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
    Magnetic Insight Announces $17 Million in Series B Funding

    BreatheSuite Adds Brad Fluegel to its Board

    Labcorp Launches At-Home Collection Device for Diabetes Risk Testing

    Thirona, Free Flow Medical Partner on COPD Solutions

    Smart Sleep Tracking Products Market to Sustain Double-Digit Growth
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development

    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Theranos Fraud Trial, Part II: The Blame Game Continues

    An Update on Surgical Robotics

    Letting the Light In: How Failure Analysis is the Cornerstone of Success

    Three Talent Strategies to Attract High-Demand Skills

    The Advantages of Bioburden Screening for Sterilization Validation
    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

    Xact Wire EDM Corp.

    Trademark Plastics Inc.

    Fusion Biotec Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    The Power of Leveraging Customer Relationships

    Cost Effective & Efficient Wire EDM Techniques

    How MedTech Professionals Can Help Combat Physician Burnout

    How to Optimize Manufacturing Lines and Choose Which Machines to Buy

    How Are Hypodermic Needles Made?
    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

    Xact Wire EDM Corp.

    Trademark Plastics Inc.

    Fusion Biotec 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 Green Lights First Test to Help Detect Cytomegalovirus in Newborns

    Although not typically a risk, the herpes virus can potentially cause serious illness in newborn babies.

    FDA Green Lights First Test to Help Detect Cytomegalovirus in Newborns
    The cytomegalovirus (CMV). The Alethia CMV Assay Test System is used as an aid in the diagnosis of congenital CMV infection. Image courtesy of CDC/Dr. Edwin P. Ewing, Jr./Wikimedia Commons.
    Related CONTENT
    • Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe
    • Medtronic Rolls Out SonarMed Pediatric Monitor
    • Study Shows Benefits of CCHD Screening Using Masimo SET Pulse Oximetry
    • Sera Prognostics Partners with Anthem and HealthCore
    • The FDA Wants to Bring Manufacturing ‘Home’
    U.S. Food and Drug Administration12.03.18
    The U.S. Food and Drug Administration permitted marketing of a new diagnostic test to aid in detecting a type of herpes virus called cytomegalovirus (CMV) in newborns less than 21 days of age.
     
    “Although most people who become infected with cytomegalovirus face little to no risk of serious illness, the virus has the potential to cause serious illness for people with weak immune systems and in newborn babies,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “This test for detecting the virus, when used in conjunction with the results of other diagnostic tests, may help health care providers more quickly identify the virus in newborns and determine the best approach for the child.”
     
    According to the Centers for Disease Control and Prevention, more than half of adults by age 40 have been infected with CMV. Most people infected with CMV show no signs or symptoms of infection. However, CMV infection can cause serious health problems for people with weakened immune systems and for some newborns. Congenital CMV occurs when a baby is infected with CMV during pregnancy. Although most babies with CMV will not have any signs or symptoms of infection, some babies can develop hearing problems or other long-term health problems.
     
    The Alethia CMV Assay Test System is used as an aid in the diagnosis of congenital CMV infection by detecting CMV deoxyribonucleic acid (DNA) from a saliva swab. Test results should be used only in conjunction with the results of other diagnostic tests and clinical information.
     
    The FDA evaluated the analytical and clinical performance of the device. Data from a prospective clinical study showed that 1,472 saliva samples out of 1,475 samples collected from newborns were correctly identified by the device as negative for the presence of CMV DNA. Three samples were incorrectly identified as positive when they were negative. Five collected saliva specimens were correctly identified as positive for the presence of CMV DNA. The FDA also reviewed data from a testing of 34 samples of archived specimens from babies known to be infected with CMV in which all the archived specimens were correctly identified by the device as positive for presence of CMV DNA.
     
    The FDA reviewed the Alethia CMV Assay Test System through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices of a new type. Along with this authorization, the FDA is establishing criteria, called special controls, which determines the requirements for demonstrating accuracy, reliability, and effectiveness of tests intended to be used as an aid in the diagnosis of congenital CMV infection. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type.
     
    This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
     
    The FDA granted marketing authorization of the Alethia CMV Assay Test System to Meridian Bioscience Inc.
    Related Searches
    • test
    • diagnostics
    • safety
    • fda
    Related Knowledge Center
    • Diagnostics
    Suggested For You
    Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe
    Medtronic Rolls Out SonarMed Pediatric Monitor Medtronic Rolls Out SonarMed Pediatric Monitor
    Study Shows Benefits of CCHD Screening Using Masimo SET Pulse Oximetry Study Shows Benefits of CCHD Screening Using Masimo SET Pulse Oximetry
    Sera Prognostics Partners with Anthem and HealthCore Sera Prognostics Partners with Anthem and HealthCore
    The FDA Wants to Bring Manufacturing ‘Home’ The FDA Wants to Bring Manufacturing ‘Home’
    RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device
    FDA OKs SentiAR FDA OKs SentiAR's Holographic Cardiac Ablation Guidance System
    FDA OKs Masimo’s Rad-G Pulse Oximeter FDA OKs Masimo’s Rad-G Pulse Oximeter
    FDA Clears Scientia Vascular FDA Clears Scientia Vascular's Zoom Wire
    FDA Authorizes First Point-of-Care COVID-19 Antibody Test FDA Authorizes First Point-of-Care COVID-19 Antibody Test
    FDA OKs Surmodics FDA OKs Surmodics' Pounce Thrombus Retrieval System
    FDA Launches the Digital Health Center of Excellence FDA Launches the Digital Health Center of Excellence
    Acutus AcQMap Catheter Cleared by FDA Acutus AcQMap Catheter Cleared by FDA
    FDA OKs Varian FDA OKs Varian's Eclipse v16.1 Proton Therapy Treatment Planning Software
    FDA Approves Expanded Use of Roche FDA Approves Expanded Use of Roche's CINtec PLUS Cytology Test

    Related Breaking News

    • Patient Monitoring
      Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe

      Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe

      Uses 12 LEDs to simultaneously offer 12 blood constituent parameters noninvasively and continuously.
      Business Wire 09.13.21

    • Patient Monitoring
      Medtronic Rolls Out SonarMed Pediatric Monitor

      Medtronic Rolls Out SonarMed Pediatric Monitor

      Alerts clinicians to potential airway obstructions during ventilation.
      Sam Brusco, Associate Editor 05.10.21

    • Study Shows Benefits of CCHD Screening Using Masimo SET Pulse Oximetry

      Study Shows Benefits of CCHD Screening Using Masimo SET Pulse Oximetry

      Prevalence of critical congenital heart disease in the Sri Lankan study was 2.02 per 1,000 live births.
      Michael Barbella, Managing Editor 04.22.21


    • Sera Prognostics Partners with Anthem and HealthCore

      Sera Prognostics Partners with Anthem and HealthCore

      Aims to improve outcomes for preterm babies.
      Globe Newswire 01.08.21

    • Contract Manufacturing
      The FDA Wants to Bring Manufacturing ‘Home’

      The FDA Wants to Bring Manufacturing ‘Home’

      The agency commissioners comment how the need to modernize the critical medical supply chain is long overdue.
      Sean Fenske, Editor-in-Chief 10.01.20


    Trending
    • The Power Of Leveraging Customer Relationships
    • Intermountain Healthcare & Siemens Healthineers Open 3 Tellica Outpatient Imaging Centers
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Magnetic Insight Announces $17 Million In Series B Funding
    • NHS England Selects Spectra Optia Apheresis System To Treat Sickle Cell Disease
    Breaking News
    • Magnetic Insight Announces $17 Million in Series B Funding
    • BreatheSuite Adds Brad Fluegel to its Board
    • Labcorp Launches At-Home Collection Device for Diabetes Risk Testing
    • Thirona, Free Flow Medical Partner on COPD Solutions
    • Smart Sleep Tracking Products Market to Sustain Double-Digit Growth
    View Breaking News >
    CURRENT ISSUE

    June 2022

    • OEMs Seek Molders Offering Timely Techniques
    • Robotic Surgery: Cutting Through to the Latest
    • Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    • 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

    Florida Food Products Acquires Javo
    Roquette Launches Nutralys Rice Protein
    New IADSA Chair Lauds Explorations of Supplementation in Healthcare Policy
    Coatings World

    Latest Breaking News From Coatings World

    The Southern Society for Coatings Technology's 84th Annual Technical Conference A Success
    PPG to Showcase Specialty Automotive, Aerospace Adhesives, Sealants at Adhesives & Bonding Expo
    PPG’s New Paint for a New Start Initiative to Transform 25-plus Schools Worldwide
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Magnetic Insight Announces $17 Million in Series B Funding
    BreatheSuite Adds Brad Fluegel to its Board
    Labcorp Launches At-Home Collection Device for Diabetes Risk Testing
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Pierre Fabre and Lonza Enter Manufacturing Agreement
    MasterControl and Elemental Machines Form Biomanufacturing Partnership
    Qosina Strengthens Aseptic Capabilities
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Benefit Exec Joins Madison Reed's Board
    Peroni & Ellis Brooklyn Launch Fragrance Collection Inspired by Italian Spritz Cocktails
    Rhode Is Trending for June, Trendalytics Says
    Happi

    Latest Breaking News From Happi

    Botanical Embedded Candles Can Be Fire Hazard, Says National Candle Association
    Caire Beauty to Celebrate Menopause Empowerment Day
    Beautycounter Launches Text Campaign for FDA Safety and Landmark Advancements Act
    Ink World

    Latest Breaking News From Ink World

    British Coatings Federation Posts Online History
    Orion Announces Price Increases, Reduced Payment Terms
    INX Troubleshooting Guide App Adds New Solutions
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    PCMC teams with IGT, Fujifilm makes big announcement and more
    Loftware recognized as 'AIDC Company of the Year'
    Schreiner MediPharm highlights sustainability of Needle-Trap technology
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Tranzonic Names VP of Supply Chain
    Ontex Climate Action Targets Approved by Science-Based Targets Initiative
    Suominen Test Center Assesses Biodegradability of Nonwovens
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    3Spine Inc. Receives IDE Approval for U.S. Pivotal Clinical Trial
    Volume-Based Procurement to Reduce Chinese Orthopedic Market Value
    Isto Biologics Rolls Out Influx Fibrant
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    NREL Names Jennifer Logan to Leadership Team as CFO
    National Grid Renewables Orders 2 GW of First Solar Modules
    EO System Company Ltd. Picks eMagin’s OLED Microdisplays for Global Projects

    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