The U.S. Department of Health and Human Services announced it will purchase an additional 30 million Abbott (NYSE:ABT) BinaxNOW tests for a variety of groups vulnerable to COVID-19. Recipients will include nursing homes, assisted living facilities, home healthcare, hospice organizations, historically black colleges and universities, Native American tribes and other vulnerable groups, the agency announced. The […]
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.
These 10 stories mattered the most for medtech in 2020
COVID-19 dominated the news, but there was so much more going on in medtech. Let’s face it: These are soul-trying times, and no one is going to miss 2020. We’re leaving behind a year of tragedy and disaster — with the COVID-19 pandemic and its more than 1.6 million deaths (more than 300,000 in the […]
FDA allows virtually-guided, at-home use of Abbott’s rapid COVID-19 test cards
Abbott (NYSE:ABT) announced today that FDA has granted an EUA for virtually-guided, at-home use of the company’s BinaxNow COVID-19 Ag Card. Abbott has partnered with digital health provider eMed to provide telehealth-supported, at-home, prescription use of the cards, which run at $25 apiece. Similar in design to some pregnancy tests, the cards produce results within minutes […]
GE Healthcare helps set up a ‘Virtual ICU’ across Oregon
As the COVID-19 pandemic ravages rural areas in the U.S., GE Healthcare (NYSE:GE) is touting “Virtual ICU” technology as a way to allow people with severe cases to stay near their homes. The medtech giant today announced a multi-year agreement with Oregon Health & Science University (OHSU) to help intensivists virtually connect with ICU patients across […]
BREAKING: BD orders for COVID-19 vaccine injection devices surpass 1 billion
Becton Dickinson (NYSE:BDX) announced today that orders have surpassed 1 billion for syringes and needles needed to deliver COVID-19 vaccines. The Franklin Lakes, N.J.–based medtech giant now has commitments from governments in countries including the United States, Australia, Belgium, Canada, Germany, Netherlands, Saudi Arabia, Spain and the United Kingdom. Get the full story on our sister […]
BD is playing a crucial role delivering COVID-19 vaccines: Here’s how
Hundreds of millions of vaccine doses will require hundreds of millions of syringes from companies such as BD. As much-hoped-for COVID-19 vaccines roll out to the public, Becton Dickinson (NYSE:BDX) faces an arguably impressive challenge: The Franklin Lakes, N.J.–based medtech giant already has commitments to provide more than 800 million needles and syringes to deliver future COVID-19 […]
Abbott secures CE Mark for test that helps measure immune repsonse to COVID-19
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 […]
BREAKING: FDA authorizes first over-the-counter, fully at-home COVID-19 test
FDA announced today that it has granted an EUA for the Ellume COVID-19 Home — the first fully at-home test for the novel coronavirus that the agency is authorizing for over-the-counter sales. FDA last month OK’d an at-home test from Lucira, but it needs a prescription. The first authorization for a non-prescription COVID test came […]
FDA data says Moderna’s COVID-19 vaccine is safe and effective
Ahead of a meeting to discuss the potential approval of the COVID-19 vaccine from Moderna (NSDQ:MRNA), FDA data says the candidate is safe and effective. Cambridge, Mass.-based Moderna filed for emergency use authorization in November, having conducted a Phase 3 study, known as the COVE study, that enrolled more than 30,000 U.S. participants, with 196 confirmed cases of COVID-19. […]
10 trends that will matter for life sciences in 2021
One silver lining of the COVID-19 pandemic is that it has accelerated the rate of change for pharma and life sciences fields in general. The pandemic has forced a rethink of how to manage clinical trials and treat patients in hospitals and their homes. And the breakneck speed of vaccine development in 2020 could potentially […]
What are the most effective COVID-19 antibody tests?
The FDA released a list of emergency use authorized COVID-19 antibodies to offer comparisons over the sensitivity of the diagnostics. Among the larger companies on the list with larger sample sizes, antibody tests made by Roche and Siemens were some of the highest-ranking diagnostics, according to the FDA comparison. Tests are in part described by […]