The medtech industry is poised for a big week with the U.S. rollout of the COVID-19 vaccine and stocks remain high from previous peaks. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 100.03 (Dec. 11), marking a minor 0.7% uptick from the 100.75 points […]
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.
BREAKING: FDA authorizes Pfizer’s COVID-19 vaccine
The U.S. FDA tonight authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX), providing a much-hoped-for tool to roll back the deadly coronavirus pandemic. The FDA authorization came a day after an advisory commission for the agency provided an upbeat assessment of the two companies’ vaccine. The agency is also coordinating with the CDC and the […]
Roche launches high-volume antigen test in Europe
Roche (SWX: RO, ROG) announced today that it launched a high-throughput SARS-CoV-2 antigen test on the European market. Basel, Switzerland-based Roche said in a news release that the antigen test is designed as an aid in the diagnosis of SARS-CoV-2, the virus causing COVID-19, in markets accepting the CE Mark. Roche has also filed for FDA emergency […]
The top 5 MassDevice stories of the week — December 11, 2020
The medtech industry continues to plug along as major news comes in about vaccines, the incoming presidential administration and more. This week’s top stories include the latest on COVID-19, Joe Biden and some additional FDA clearances, plus a major royalties spat. Want to hear more about the week’s top medtech news on MassDevice? Tom Salemi will […]
Rheonix gains expanded EUA for COVID-19 diagnostic
Rheonix announced that it has received expanded FDA emergency use authorization for its Rheonix COVID-19 MDx assay. Ithaca, N.Y.-based Rheonix’s expanded authorization allows the use of saliva as an approved sample type after the assay was initially authorized for use on a range of respiratory specimens in April, according to a news release. The Rheonix […]
While FDA advisory panel backs Pfizer’s COVID-19 vaccine, patient advocates urge caution
Today, an FDA advisory panel recommended that the COVID-19 vaccine candidate from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) be granted emergency use authorization (EUA). A total of 77% of the 22 panelists voted “yes” to issue an EUA for the vaccine. In the past week, three countries — UK, Canada and Bahrain — granted emergency use […]
PPE makers want revamp of pandemic planning and supply distribution
Personal protective equipment manufacturers are asking the federal government to beef up its planning for and management of future pandemics to avoid the shortages that have endangered healthcare workers during COVID-19. Representatives of the International Safety Equipment Association (ISEA), which includes the major manufacturers of N95 masks, told reporters today that they plan to ask the federal […]
Edwards Lifesciences projects TAVR, overall growth in 2021
Edwards Lifesciences (NYSE:EW) is projecting significant growth for 2021, particularly in its transcatheter aortic valve replacement business. Irvine, Calif.-based Edwards is projecting 2021 TAVR sales to represent growth of between 15% and 20% as well as growth in the mid-teens for global sales, the company shared during its investor day presentation. Additionally, Edwards projected adjusted earnings […]
LabCorp wins FDA EUA for at-home COVID-19 test kit
Laboratory Corporation of America (NYSE:LH) announced that it received FDA emergency use authorization (EUA) for its COVID-19 test home collection kit. Burlington, N.C.-based LabCorp’s Pixel by LabCorp COVID-19 test home collection kit’s EUA makes it the first test kit available over the counter without requiring a prescription, enabling LabCorp to potentially distribute the kit through retail […]
Canada signs off on Pfizer-BioNTech COVID-19 vaccine
Canada’s health regulator has authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). Pfizer submitted documentation related to the BNT162b2 vaccine to Canadian regulators on Oct. 9, 2020. “Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place,” Health Canada explained in a statement. The agency also stressed […]
EZaccessMD launches at-home rapid COVID-19 test
Subscription-based telehealth provider EZaccessMD announced that it launched a rapid, in-home COVID-19 test from Becton Dickinson (NYSE:BDX). Rochester, N.Y.-based EZaccessMD said in a news release that its new offering for subscribers brings mobile testing equipment and a qualified provider into the home at no extra charge. The company touts a two-hour response time and test result […]