Cepheid announced today that it received FDA emergency use authorization (EUA) for its Xpert Xpress CoV-2/Flu/RSV Plus diagnostic. Sunnyvale, California-based Cepheid designed its Xpert Xpress Plus as a rapid molecular diagnostic test for the qualitative detection of the viruses causing COVID-19, Flu A, Flu B and respiratory syncytial virus (RSV). Nearly one year ago, 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.
Scancell picks PharmaJet’s needle-free injection systems to deliver COVID-19 vaccine candidates
PharmaJet announced today that its partner, Scancell, chose its needle-free injection platform to administer its COVID-19 vaccine candidates. Scancell selected Golden, Colorado-based PharmaJet’s devices to administer two SARS-CoV-2 DNA-based vaccine candidates, SCOV1 and SCOV2. The vaccines will be exclusively administered using the PharmaJet Tropis and PharmaJet Stratis needle-free injection systems. Get the full story at our sister […]
FDA outlines plan to ‘follow the science’ as it mulls over COVID-19 vaccines for children
FDA leaders have issued a statement regarding the agency’s plan moving forward with regards to authorizing COVID-19 vaccines for children. The FDA plans to “follow the science” with eyes on COVID-19 vaccines for children younger than 12 as schools begin to get back in session around the country, the agency said in a news release […]
Moderna submits initial data to FDA for COVID-19 vaccine booster
Moderna (NSDQ:MRNA) announced that it initiated its submission to the FDA for a booster dose of its COVID-19 vaccine. Cambridge, Massachusetts-based Moderna expects to submit data to the European Medicines Agency and other regulatory authorities around the world in addition to the FDA in the coming days for the booster shot at a 50 µg dose […]
Report: Two vaccine leaders set to step down from FDA
Two senior vaccine leaders within the FDA are reportedly relinquishing their positions within the administration. According to a report from Endpoints News, which cites a letter released internally to FDA staff first reported on by BioCentury, Marion Gruber and Phil Krause will depart in the coming months due to frustrations over the delegation of certain decisions within some governing […]
Overcoming vaccine delivery device design’s top challenges
Vaccine delivery has long been a hot topic and only got hotter in the ongoing push to vaccinate against COVID-19 around the world. Most would probably associate vaccines with the standard “jab” injection with a syringe. Over the past year and more, companies have touted ideas for other avenues. Inovio has a “smart” delivery device for […]
Amazon makes moves for a major medical diagnostics play
Amazon (NASDAQ: AMZN) wants to hire key employees to expand its medical diagnostics operations on a global scale, which very well could grow beyond COVID-19 testing. Senior-level job postings offer a glimpse of the notoriously secretive and ambitious tech company’s global aspirations for medical diagnostics. Just this week, Amazon put a call out for a […]
Pfizer seeks FDA blessing for COVID-19 vaccine booster
Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) aim to expand the recent FDA approval of their COVID-19 vaccine to include booster doses for individuals 16 and older. The companies have submitted a supplemental Biologics License Application to the FDA, including Phase 3 data drawn from participants aged 15 to 55. The latest data indicate that […]
Janssen COVID-19 booster leads to nine-fold increase in neutralizing antibodies
Johnson & Johnson (NYSE:JNJ) has announced that a booster of its viral-vector COVID-19 vaccine led to considerable increases in coronavirus spike-binding antibodies, according to interim data from two Phase 1/2 trials known as VAC31518COV1001 and VAC31518COV2001. In particular, the boosters led to a nine-fold increase in antibodies relative to levels 28 days after administering the prime […]
Abbott disputes New York Times story about destroyed COVID-19 test inventory
Abbott (NYSE:ABT) has responded to a New York Times article reporting the disposal of COVID-19 test inventory at a Maine factory. The New York Times article on Aug. 20 stated that, as COVID-19 cases dwindled in the U.S. in June and July, workers at Abbott’s Westbrook, Maine, facility that produced its BinaxNow rapid COVID-19 tests were […]
FDA approves Pfizer-BioNTech COVID-19 vaccine
The FDA today issued approval for Pfizer and BioNTech’s COVID-19 vaccine, making it the first to receive full approval in the U.S. The approval covers the prevention of COVID-19 in individuals 16 years of age and older. In addition, the vaccine remains available under FDA emergency use authorization (EUA) for people who are 12 years […]
