• 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
    • MPR: Breakthrough Products Series
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Job Board
    • Leadership in Medtech
    • Manufacturer Search
    • MedTech 100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
    • DeviceTalks
  • Coronavirus: Live updates

COVID-19

Is J&J’s COVID-19 vaccine linked to tinnitus?

February 25, 2021 By Brian Buntz Leave a Comment

In Johnson & Johnson’s (NYSE:JNJ) Phase 3 trial for the Ad26.COV2.S COVID-19 vaccine, six vaccine recipients developed tinnitus or ringing in the ears. In five of those individuals, tinnitus had either resolved or was resolving. The condition was unresolved in the other trial volunteer. No placebo recipients developed the condition. Get the full story from Drug […]

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceutical Tagged With: Ad26.COV2.S, Clinical Trials, coronavirus, COVID-19, COVID-19 vaccine, Johnson & Johnson, Johnson and Johnson, tinnitus

FDA analysis finds J&J’s single-done COVID-19 vaccine is safe, effective

February 24, 2021 By Sean Whooley Leave a Comment

An FDA analysis found that the single-dose COVID-19 vaccine candidate developed by Johnson & Johnson (NYSE:JNJ) is safe and effective. The analysis comes two days ahead of the FDA’s meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the EUA request for the vaccine. Johnson & Johnson submitted the EUA […]

Filed Under: Clinical Trials, Featured, Food & Drug Administration (FDA), Pharmaceutical, Regulatory/Compliance Tagged With: coronavirus, COVID-19, COVID-19 vaccine, COVID-19 vaccine trial, FDA, Janssen Pharmaceuticals, Johnson & Johnson

Medtronic rises on Street-beating Q3

February 23, 2021 By Sean Whooley Leave a Comment

Medtronic (NYSE:MDT) shares ticked up when the market opened today on third-quarter results that topped the consensus forecast. The Fridley, Minn.-based medtech giant posted profits of $1.3 billion, or 94¢ per share, on sales of $7.8 billion for the three months ended Jan. 29, 2021, for a -33.4% bottom-line slide on sales growth of 0.8%. Adjusted […]

Filed Under: Business/Financial News, Cardiovascular, Diabetes, Featured, MassDevice Earnings Roundup, Surgical, Wall Street Beat Tagged With: coronavirus, COVID-19, Medtronic

FDA issues guidelines to address COVID-19 variants

February 22, 2021 By Sean Whooley Leave a Comment

The FDA today issued guidance for medical product developers to address the emergence of variants of SARS-CoV-2, which causes COVID-19. Variants of the virus have been detected in multiple countries across the globe, including the U.S., and they pose a major threat to potentially ending the COVID-19 pandemic as protocols such as mask-wearing and hand-washing […]

Filed Under: Business/Financial News, Diagnostics, Featured, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Pharmaceutical, Regulatory/Compliance Tagged With: BioNTech, coronavirus, COVID-19, COVID-19 vaccine, COVID-19 variants, FDA, Moderna, Pfizer

BD, Scanwell Health collaborating on smartphone-enabled, home COVID-19 rapid test

February 22, 2021 By Sean Whooley Leave a Comment

Becton Dickinson (NYSE:BDX) announced today that it is collaborating with Scanwell Health to create an at-home rapid COVID-19 test. Scanwell Health, a developer of smartphone-enabled at-home medical tests, will offer its mobile app to pair with a BD antigen test for SARS-CoV-2, the virus causing COVID-19, according to a news release. As part of the collaboration, […]

Filed Under: Business/Financial News, Diagnostics, Digital Health, Featured, Genomics/Molecular Diagnostics, Health Technology, Research & Development, Software / IT Tagged With: BD, becton dickinson, coronavirus, COVID-19, Scanwell Health

MedTech 100 roundup: Slight dip after all-time best for industry

February 22, 2021 By Sean Whooley Leave a Comment

The medtech industry’s stocks rose higher than they ever had to begin last week before eventually dropping to a slightly more normal level. MassDevice‘s MedTech 100 index ended the week (Feb. 19) at 108.72 points, marking a -1.7% dip from the 110.63-point mark set at the end of the previous week (Feb. 12). On Monday (Feb. […]

Filed Under: Business/Financial News, Diagnostics, Featured, Food & Drug Administration (FDA), Funding Roundup, Genomics/Molecular Diagnostics, Mergers & Acquisitions, Regulatory/Compliance, Wall Street Beat Tagged With: Butterfly Network, coronavirus, COVAX, COVID-19, FDA, Henry Schein One, Joe Biden, Mainstay Medical, MedTech 100 Index, Medtronic, Personnel Moves, Retractable Technologies Inc., Zimmer Biomet

Pfizer vaccine stable at standard freezer temps, effective with single dose

February 19, 2021 By Brian Buntz Leave a Comment

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have submitted data to FDA indicating that their vaccine is stable at –25° C to –15°C. Currently, the vaccine can be stored in an ultra-cold freezer between –80° C and –60° C, according to current CDC guidelines. Updating the companies’ emergency use authorization prescribing information would be simplify logistics. It would […]

Filed Under: Featured, Pharmaceutical Tagged With: BioNTech, coronavirus, COVID-19, Pfizer

Biden announces $4B to support global vaccinations worldwide

February 19, 2021 By Sean Whooley Leave a Comment

President Joe Biden announced that the U.S. is set to provide $4 billion to the COVAX Facility to support access to safe and effective COVID-19 vaccines. Money appropriated by a December 2020 Congressional vote will comprise an initial $2 billion contribution to Gavi, the Vaccine Alliance for the COVAX advance market commitment (AMC) covering 92 […]

Filed Under: Business/Financial News, Contract Manufacturing, Featured, Pharmaceutical Tagged With: BioNTech, coronavirus, COVAX, COVID-19, COVID-19 vaccine, GlaxoSmithKline plc, Johnson & Johnson, Pfizer, Sanofi

J&J submits EUL application to WHO for single-shot COVID-19 vaccine

February 19, 2021 By Sean Whooley Leave a Comment

Johnson & Johnson (NYSE:JNJ) announced today that it submitted for emergency use listing (EUL) to the World Health Organization (WHO) for its COVID-19 vaccine. New Brunswick, N.J.-based J&J’s Janssen subsidiary’s single-dose COVID-19 vaccine candidate was submitted for EUL with a data package including interim efficacy and safety results from the Phase 3 Ensemble clinical trial, which […]

Filed Under: Clinical Trials, Featured, Pharmaceutical, Regulatory/Compliance Tagged With: coronavirus, COVID-19, COVID-19 vaccine, Janssen Pharmaceuticals, Johnson & Johnson, World Health Organization

EU and US take steps to battle coronavirus mutations

February 18, 2021 By Brian Buntz Leave a Comment

The EU recently added clauses to COVID-19 vaccine contracts to prioritize vaccines that are effective against emerging SARS-CoV-2 variants. Meanwhile, a U.S. House bill that would provide $1.75 billion for genomic sequencing of coronavirus samples is scheduled for floor debate and the Senate is considering similar legislation. The UK variant (B.1.1.7) that is spreading across […]

Filed Under: Pharmaceutical Tagged With: coronavirus, COVID-19

This vocal biomarker software can screen for COVID-19

February 18, 2021 By Nancy Crotti Leave a Comment

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

  • Go to page 1
  • Go to page 2
  • Go to page 3
  • Interim pages omitted …
  • Go to page 73
  • 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