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 […]
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.
Integra LifeSciences posts earnings beat in Q4
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 […]
Feds to spend $1.6B to expand COVID testing, domestic manufacturing
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 […]
FDA lets Everlywell sell its COVID-19 home collection kit direct to consumers
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 […]
EUAs help push FDA to record novel-device nods in 2020
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). […]
4 things to keep in mind as COVID-19 vaccination efforts scale
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 […]
Henry Schein dips despite Street-beating Q4
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 […]
J&J applies for COVID vaccine approval in Europe
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 […]
FDA issues mea culpa for early COVID-19 serology test nods
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 […]
FDA issues EUA for Thermo Fisher Scientific COVID-19, flu combo test
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, […]
MedTech 100 roundup: Rise to new heights continues
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 […]
