• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » BD wins CE mark for 15-minute COVID-19 diagnostic test

BD wins CE mark for 15-minute COVID-19 diagnostic test

September 30, 2020 By Sean Whooley

Becton DickinsonBecton Dickinson (NYSE:BDX) announced today that it received CE Mark approval in Europe for its rapid COVID-19 test.

Franklin Lakes, N.J.-based BD’s rapid, point-of-care SARS-CoV-2 antigen test — used on the BD Veritor Plus system — delivers results in 15 minutes on a portable instrument to allow for on-site results and decision making, according to a news release.

BD’s test has been available in the U.S. since July after receiving FDA emergency use authorization (EUA) but now expands to Europe, where the BD Veritor Plus system is already in use for testing with Group A Strep, influenza A & B and respiratory syncytial virus (RSV).

The BD Veritor Plus, which is slightly larger than a mobile phone, includes an easy-to-use workflow for point-of-care use and offers traceability and reporting capabilities through the BD Synapsys informatics platform. Its ability to test for both SARS-CoV-2 (the virus causing COVID-19) and influenza A & B aligns with the recent European Centre for Disease Prevention & Control guidance that all patients with acute respiratory symptoms should be tested for both in parallel during flu season.

By leveraging its global manufacturing network, BD intends to produce 8 million SARS-CoV-2 antigen tests per month by October, with 12 million tests set as the total expected per month by March 2021.

“Availability of the SARS-CoV-2 assay on the BD Veritor Plus system in Europe builds on our molecular test on the BD MAX system that has been available since March,” BD EMEA region president Roland Goette said in the news release. “The addition of a truly portable, point-of-care test that can deliver results while the patient waits will be welcomed by health care providers and patients alike to help protect against additional waves of COVID-19.”

Filed Under: Diagnostics, Featured, Genomics/Molecular Diagnostics, Regulatory/Compliance Tagged With: becton dickinson, CE Mark, coronavirus, COVID-19

More recent news

  • Comphya raises CHF 7.5 million for neurostim to treat ED
  • Fujifilm launches intelligent automation features for digital radiography
  • Integer appoints former iRhythm CEO to board
  • MMI debuts robotic surgery instruments, digital surgery platform
  • Synchrony Medical wins FDA nod for airway clearance system

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy