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coronavirus

Here at MassDevice — medtech's online business journal — we're covering news about the coronavirus (COVID-19) pandemic daily. Here is the latest about coronavirus and the medical device industry, regulatory changes related to the pandemic, new tests for the virus, vaccine development, and much more.

Pfizer, BioNTech start trial to evaluate COVID-19 vaccine’s effect on pregnant women

February 18, 2021 By Sean Whooley

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that it dosed the first participants in a trial of its COVID-19 vaccine for pregnant women. The companies, which developed one of the two COVID-19 vaccines to be authorized in the U.S. so far, are conducting a global Phase 2/3 study to evaluate the safety, tolerability and immunogenicity of the vaccine […]

Filed Under: Clinical Trials, Pharmaceutical, Women's Health Tagged With: BioNTech, coronavirus, COVID-19, COVID-19 vaccine, COVID-19 vaccine trial, Pfizer

Integra LifeSciences posts earnings beat in Q4

February 18, 2021 By Sean Whooley

Integra LifeSciences (NSDQ:IART) shares dipped today despite fourth-quarter results that beat the consensus earnings forecast. The Princeton, N.J.-based medtech company posted profits of $92.7 million, or $1.09 per share, on sales of $388.6 million for the three months ended Dec. 31, 2020, coming in well ahead of its Q4 2019 profit of $15.3 million despite a […]

Filed Under: Business/Financial News, Featured, MassDevice Earnings Roundup, Wall Street Beat Tagged With: coronavirus, COVID-19, Integra LifeSciences

Feds to spend $1.6B to expand COVID testing, domestic manufacturing

February 17, 2021 By Nancy Crotti

The Biden administration announced plans today to expand COVID-19 testing across the country, boost domestic manufacturing of tests and testing supplies and increase virus genome sequencing to detect virus variants. The departments of Health and Human Services and Defense will jointly invest $650 million to expand testing for K-8 schools and underserved congregate settings, such […]

Filed Under: Business/Financial News, Diagnostics, Featured, Lab Instruments & Supplies Tagged With: AdvaMed, coronavirus, COVID-19, COVID-19 variants, Dept. of Health & Human Services (HHS), U.S. Centers for Disease Control and Prevention (CDC), U.S. Department of Defense

FDA lets Everlywell sell its COVID-19 home collection kit direct to consumers

February 17, 2021 By Sean Whooley

Everlywell announced today that it received FDA emergency use authorization for its COVID-19 test home collection kit DTC. Under EUA, the home collection kit made by Everlywell can now be used directly by individuals who are not experiencing symptoms and have no suspected exposure and who are without a doctor’s prescription, according to a news […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Regulatory/Compliance Tagged With: coronavirus, COVID-19, Everlywell, FDA

EUAs help push FDA to record novel-device nods in 2020

February 17, 2021 By Nancy Crotti

The FDA approved, cleared or authorized a record high of 132 novel medical devices in 2020, with pandemic-related emergency use authorizations (EUAs) adding significantly to the total. That compares with 29 novel devices the agency authorized in 2010, according to a new article by officials from the agency’s Center for Devices and Radiological Health (CDRH). […]

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: coronavirus, COVID-19, De Novo Clearance, FDA

4 things to keep in mind as COVID-19 vaccination efforts scale

February 17, 2021 By Brian Buntz

In the early days of the pandemic, hopes were high that a vaccine could return society to normalcy. But now that FDA has authorized two vaccines, much of the general public is waiting for them to become broadly available. Some 4.5% of the U.S. population has been fully vaccinated as of Feb. 17, according to […]

Filed Under: Pharmaceutical Tagged With: coronavirus, COVID-19, COVID-19 vaccines, FDA, Winston & Strawn

Henry Schein dips despite Street-beating Q4

February 17, 2021 By Sean Whooley

Henry Schein (NSDQ:HSIC) shares dipped today despite fourth-quarter results that topped the consensus forecast. The Melville, N.Y.-based company posted profits of $142.6 million, or 99¢ per share, on sales of $3.2 billion for the three months ended Dec. 26, 2020, for a -56.8% bottom-line slide on sales growth of 18.6%. Adjusted to exclude one-time items, earnings […]

Filed Under: Business/Financial News, Dental, Featured, MassDevice Earnings Roundup, Wall Street Beat Tagged With: coronavirus, COVID-19, Henry Schein Inc., Henry Schein Medical

J&J applies for COVID vaccine approval in Europe

February 16, 2021 By Sean Whooley

Johnson & Johnson (NYSE:JNJ) announced today that it submitted a conditional marketing authorization application (cMAA) for its COVID-19 vaccine. New Brunswick, N.J.-based J&J’s cMAA application with the European Medicines Agency (EMA) is seeking authorization for the investigational, single-dose COVID-19 vaccine candidate developed by its Janssen subsidiary, according to a news release. The submission is based on […]

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

FDA issues mea culpa for early COVID-19 serology test nods

February 16, 2021 By Nancy Crotti

Early in the pandemic, when the numbers of asymptomatic COVID-19 cases were mounting, officials at the FDA decided to authorize the use of serology tests that laboratories had validated but that the agency hadn’t actually reviewed. Now two FDA officials are admitting that this was a mistake, but one the agency has learned from. In […]

Filed Under: Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Center for Devices and Radiological Health (CDRH), coronavirus, COVID-19, Ellume, FDA

FDA issues EUA for Thermo Fisher Scientific COVID-19, flu combo test

February 16, 2021 By Sean Whooley

Thermo Fisher Scientific (NYSE:TMO) announced today that it received FDA emergency use authorization (EUA) for a COVID-19/flu combo test. Carlsbad, Calif.-based Thermo Fisher’s Applied Biosystems TaqPath COVID-19, Flu A, Flu B combo kit is a real-time PCR test for detecting and differentiating RNA from SARS-CoV-2, influenza A and influenza B viruses in nasopharyngeal and nasal swabs, […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Regulatory/Compliance Tagged With: coronavirus, COVID-19, FDA, Thermo Fisher Scientific

MedTech 100 roundup: Rise to new heights continues

February 16, 2021 By Sean Whooley

The medtech industry hit another high as 2021 continues to bring strong performances out of some of the biggest companies around. MassDevice‘s MedTech 100 index ended the week (Feb. 12) at 110.63 points, marking a 2.2% rise from the 108.23-point mark set at the end of the previous week (Feb. 5). The final mark for the […]

Filed Under: Business/Financial News, Featured, MassDevice Earnings Roundup, Mergers & Acquisitions, Wall Street Beat Tagged With: Butterfly Network, coronavirus, COVID-19, Dexcom, iRhythm Technologies Inc., MedTech 100 Index, Moderna, Pfizer, Philips, Schivo

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