Pfizer (NYSE:PFE) has announced its vaccine candidate promises to be 90% effective in protecting against COVID-19 infections. The announcement included the interim analysis results of its Phase 3 trial. Pfizer had earlier suggested that it would announce those results in late October. The promising data clears the way for Pfizer to apply for emergency-use authorization from FDA […]
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.
MedTech 100 roundup: Stocks show no signs of slowing down
The medtech industry hit further highs in the market last week and the stocks show no sign of stopping their ascent now. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 97.62 (Nov. 6), marking a 7.3% leap from the 91.01 points registered at the […]
FDA issues EUA for GenScript’s COVID-19 neutralizing antibody detection kit
GenScript announced today that it received FDA emergency use authorization (EUA) for its cPass SARS-CoV-2 neutralizing antibody detection kit. Piscataway, N.J.-based GenScript touts its test as the first commercially available diagnostic for specifically detecting neutralizing antibodies without the use of live virus. It measures the presence of neutralizing antibodies in any sample, both in patients […]
Mesa Biotech lands $13M to develop rapid COVID/flu test
Mesa Biotech announced today that it was awarded $13 million by BARDA to develop its COVID-19 and flu molecular diagnostic. San Diego-based Mesa Biotech received the contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and […]
Study: Abbott antigen test can detect COVID-19 in asymptomatic people
A study out of Spain found that an antigen test made by Abbott (NYSE:ABT) is capable of detecting COVID-19 infection in asymptomatic people. Antigen-based rapid diagnostic tests are seen as a potential alternative to the standard for COVID-19 diagnosis, the RT-qPCR test, which has drawbacks including the need for laboratory processing, high cost and some long […]
Eurofins launches SARS-CoV-2 test kit
Eurofins (Paris:ERF.PA) announced today that it launched the GSD NovaPrime SARS-CoV-2 Mplex FLA (Sanger) kit for COVID-19 testing. Luxembourg-based Eurofins’ test kit uses the fragment length analysis principle on Sanger sequencing instruments, such as the ABI 373xl, with the assay enabling each sequencer to process more than 2,000 samples per day while the kit provides sensitivity […]
BD beats The Street in Q4, posts 2021 guidance
Becton Dickinson (NYSE:BDX) reported Street-beating fourth-quarter financial results and revealed its 2021 fiscal guidance. The Franklin Lakes, N.J.-based company posted profits of $128 million, or 36¢ per share, on sales of $4.8 billion for the three months ended Sept. 30, 2020, for a -21.5% bottom-line slide on sales growth of 4.4%. Adjusted to exclude one-time items, […]
Hologic rises on Street-beating Q4
Hologic (NSDQ:HOLX) shares got a boost today on fourth-quarter results that topped the consensus forecast. The Marlborough, Mass.-based diagnostic company posted profits of $495 million, or $1.88 per share, on sales of $1.35 billion for the three months ended Sept. 26, 2020, for a massive bottom-line gain from the red on sales growth of 55.6%. Adjusted […]
Study: Smartwatches, fitness trackers can detect COVID-19
Researchers are touting the use of personal sensor data from wearable technologies for identifying markers that could indicate COVID-19 infection. Led by Giorgio Quer, the research team developed a smartphone app for collecting smartwatch and activity tracker data, as well as self-reported symptoms and diagnostic testing results from individuals in the U.S., according to the […]
Report: Oxford chief says there’s ‘small chance’ COVID-19 vaccine is ready by Christmas
The director of the group developing a COVID-19 vaccine candidate at Oxford University says it’s possible that the vaccine could be ready by Christmas. According to a Reuters report, Oxford vaccine trial chief investigator Andrew Pollard said he’s optimistic that the university, which is collaborating with AstraZeneca on the vaccine, will present trial results by the end […]
FDA flags false-positives with COVID-19 antigen tests
The FDA announced today that it is alerting laboratory staff and healthcare providers of false-positive results for rapid COVID-19 antigen tests. Generally, antigen tests are indicated for the qualitative detection of SARS-CoV-2 antigens in authorized specimen types collected from individuals suspected of COVID-19 by their healthcare provider within a certain number of days of symptom […]