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

MassDevice

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

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts
    • DeviceTalks Weekly
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Job Board
    • Leadership in Medtech
    • Manufacturer Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
    • DeviceTalks
  • Coronavirus: Live updates

CE Mark

Abbott wins CE mark for next-generation TriClip

April 8, 2021 By Sean Whooley Leave a Comment

Abbott (NYSE:ABT) announced today that it received CE mark approval for its next-generation TriClip transcatheter tricuspid valve repair system. The company touts the TriClip as a first-of-its-kind, minimally invasive tricuspid heart valve repair device for treating tricuspid regurgitation (TR), according to a news release. Abbott Park, Ill.–based Abbott’s clip-based therapy is a non-surgical heart valve […]

Filed Under: Cardiac Implants, Cardiovascular, Featured, Regulatory/Compliance, Replacement Heart Valves, Structural Heart Tagged With: Abbott, CE Mark

Abbott Xience stent gains expanded CE mark

April 6, 2021 By Sean Whooley Leave a Comment

Abbott (NYSE:ABT) announced today that its Xience stent received CE mark approval for a shorter duration of dual anti-platelet therapy (DAPT). The European approval for the stent allows for the DAPT to go as short as 28 days, the shortest indication available in the world for patients with high bleeding risk (HBR), according to a news […]

Filed Under: Blood Management, Cardiac Implants, Cardiovascular, Featured, Regulatory/Compliance, Stents, Structural Heart Tagged With: Abbott, Abbott Vascular, CE Mark

Praxis Medical wins CE mark for CytoCore soft tissue biopsy device

March 10, 2021 By Sean Whooley

Praxis Medical announced that it received CE mark approval for its CytoCore soft tissue biopsy device. Tampa, Fla.-based Praxis said in a March 8 news release that the approval for CytoCore allows the country to expand its technology into European Union member countries and offer fine-needle biopsies on a global scale. CytoCore is designed to […]

Filed Under: Diagnostics Tagged With: CE Mark, Praxis Medical

This vocal biomarker software can screen for COVID-19

February 18, 2021 By Nancy Crotti

Startup Vocalis Health today announced that its artificial intelligence-aided screening tool, VocalisCheck, screening tool, VocalisCheck, has obtained a CE mark for screening for COVID-19. VocalisCheck is designed as a screening tool that can deliver a reliable risk score to guide people who may need diagnostic testing for the coronavirus. A smartphone or other device using […]

Filed Under: Business/Financial News, Featured, Regulatory/Compliance Tagged With: CE Mark, coronavirus, COVID-19, Vocalis Health

Roche obtains CE Mark for rapid COVID-19 test with easier nose collection

February 1, 2021 By Sean Whooley

Roche (SWX: RO, ROG) announced today that it received CE Mark approval for its new SARS-CoV-2 nasal rapid antigen test. Basel, Switzerland-based Roche’s nasal test collects the sample from the front area of the nose instead of the nasopharynx, which is the method used with its existing SARS-CoV-2 rapid antigen test. The new method results in a simplified […]

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

Abbott Panbio rapid antigen test wins CE mark for asymptomatic COVID-19 screening

January 26, 2021 By Sean Whooley

Abbott (NYSE:ABT) announced today that it received CE Mark for two new uses of its Panbio COVID-19 Ag rapid diagnostic. Panbio COVID-19 Ag has received an updated label with clinical data on asymptomatic individuals to enable mass testing of people who do not currently present symptoms of the disease, according to a news release. The other […]

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

TransEnterix receives CE Mark for AI for its robotic surgery system

January 19, 2021 By Sean Whooley

TransEnterix (NYSE:TRXC) announced today that it received CE Mark approval for its Intelligent Surgical Unit for the Senhance system. The Intelligent Surgical Unit (ISU) enables machine vision capabilities on the Senhance surgical system, providing Senhance digital laparoscopic programs in Europe augmented intelligence capabilities in surgical settings, according to a news release. The FDA cleared the ISU […]

Filed Under: Digital Health, Featured, Health Technology, Imaging, Regulatory/Compliance, Software / IT, Surgical Tagged With: CE Mark, TransEnterix

Distalmotion gains CE Mark for surgical robot

December 30, 2020 By Sean Whooley

Distalmotion announced that it received CE Mark approval for its Dexter surgical robot for minimally invasive surgical care. Lausanne, Switzerland-based Distalmotion said in a news release that its Dexter system combines the affordability of laparoscopy with the benefits of robotic surgery to increase simplicity and versatility in the space. Distalmotion said Dexter is ready for […]

Filed Under: Featured, Regulatory/Compliance, Robotics, Surgical Tagged With: CE Mark, Distalmotion

Abbott secures CE Mark for test that helps measure immune repsonse to COVID-19

December 15, 2020 By Sean Whooley

Abbott (NYSE:ABT) announced today that it received CE Mark approval for its new SARS-CoV-2 IgG lab-based serology test. The Abbott Park, Ill.-based company’s IgG antibody test for the virus causing COVID-19 offers a quantitative result to help evaluate a person’s immune response to a vaccine, according to a news release. Abbott’s quantitative IgG antibody test detects […]

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

Cardio-Phoenix secures CE Mark for AI-powered heart diagnostic

December 14, 2020 By Sean Whooley

Cardio-Phoenix recently announced that it received CE Mark approval for its Cardio-Heart heart disease diagnostic device. European approval came in October for the “Chart” system which combines a device for capturing the heart’s physiological bio-signals with a cloud-based, AI-powered diagnostic analysis engine, according to a news release. Cardio-Phoenix said the system is designed to ensure […]

Filed Under: Cardiovascular, Diagnostics, Regulatory/Compliance Tagged With: Cardio-Phoenix, CE Mark

Abbott launches next-gen 3D cardiac mapping platform in Europe, Australia

November 2, 2020 By Sean Whooley

Abbott (NYSE:ABT) announced today that it received CE Mark and Australian approval for its new EnSite X EP system. EnSite X EP is touted as the only system that allows for navigation of the cardiac anatomy in two different ways through the same lone platform. The new cardiac mapping platform builds upon Abbott’s electrophysiology portfolio with […]

Filed Under: Business/Financial News, Cardiovascular, Catheters, Featured, Imaging, Structural Heart Tagged With: Abbott, CE Mark

  • Go to page 1
  • Go to page 2
  • Go to page 3
  • Interim pages omitted …
  • Go to page 25
  • Go to Next Page »

Primary Sidebar

MEDTECH 100 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.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Tweets by @MassDevice
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion

MASSDEVICE

Subscribe to MassDevice
Advertise with us
About
Contact us

Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2021 · 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.

Advertise | Privacy Policy | RSS