The FDA has granted Google’s (NSDQ:GOOGL) Verily emergency use authorization (EUA) for its pooled COVID-19 testing. In a letter to the company dated yesterday, the FDA confirmed the EUA status for the qualitative test for detecting nucleic acid from SARS-CoV-2 in respiratory specimens procured through nasal, mid-turbinate, nasopharyngeal and oropharyngeal swabbing. The test also can be […]
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.
Thermo Fisher to manufacture Inovio COVID-19 vaccine candidate
Inovio Pharmaceuticals (NSDQ:INO) announced that Thermo Fisher Scientific (NYSE:TMO) will manufacture its COVID-19 vaccine candidate. Plymouth Meeting, Pa.-based Inovio said in a news release yesterday that Thermo Fisher signed a letter of intent to manufacture the INO-4800 COVID-19 vaccine candidate, joining a consortium of third-party manufacturers that aim to produce 100 million doses of Inovio’s vaccine by 2021, […]
Pfizer touts animal trial results for COVID-19 vaccine candidate
Pfizer (NYSE:PFE) announced today that its COVID-19 vaccine candidate protected against infection in preliminary non-human trials. The vaccine, being developed in collaboration with BioNTech (NSDQ:BNTX), was tested in mouse and non-human primate models. In the non-human primate study, the BNT162b2 mRNA-based vaccine candidate protected rhesus macaques against SARS-CoV-2 infection, according to a news release. Get the full story […]
AstraZeneca puts COVID-19 vaccine trial on hold
AstraZeneca (NYSE:AZN) announced today that it voluntarily paused the trials for its COVID-19 vaccine candidate after an unexplained illness. The company said in a news release that a standard review process was triggered so an independent committee could review safety data surrounding a single event of an unexplained illness that occurred in the UK Phase III […]
How the presidential election could affect medtech
No matter who ends up in the White House, there will need to be a reckoning over how the government’s relationship with medtech has changed, according to industry insiders. It’s been a tumultuous few years for the medical device industry, with highs and lows that no one could have foreseen. President Donald Trump’s administration streamlined […]
Drug companies agree not to release COVID-19 vaccine until it’s ready
Executives from nine different drug companies today announced a pledge to ensure safety with a potential COVID-19 vaccine. The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NSDQ:BNTX), GlaxoSmithKline (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Moderna (NSDQ:MRNA), Novavax (NSDQ:NVAX), Pfizer (NYSE:PFE) and Sanofi (NYSE:SNY), all of whom are developing vaccine candidates, all signed the pledge, which vows to “uphold the integrity of the scientific process” […]
MedTech 100 roundup: Stocks top pre-pandemic high
After weeks of flirting with the heights hit before COVID-19 ravaged the markets, medtech stocks finally topped the pre-pandemic high last week. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — spiked up to 93.11 points on Sep. 2, nearly a full point ahead of the pre-pandemic high of […]
How decontamination could solve the COVID-19 mask shortage problem
With cold and flu season rapidly approaching, public health officials worry about a resurgence of COVID-19 and personal protective equipment shortages. Protecting frontline workers will likely include decontaminating face masks. A spike in COVID-19 cases this fall and winter could leave healthcare facilities with renewed shortages of personal protective equipment — particularly masks. Hundreds of […]
Roche test for both COVID-19 and influenza receives EUA
Roche (SWX: RO, ROG) announced today that the FDA has granted an EUA for its Cobas SARS-CoV-2 and Influenza A/B Test for use on Cobas 6800 and 8800 systems. The test is also available in nations accepting the European Union’s CE Mark. The new Roche test can provide simultaneous qualitative detection and differentiation of SARS-CoV-2, […]
Cummins is supplying material for millions of face masks against COVID-19
Cummins (NYSE:CMI) is making material for millions of face masks out of its Cookeville, Tenn., filtration plant — thanks to a partnership with the U.S. Department of Energy’s Oak Ridge National Laboratory nearby. “Because of our expertise in the automotive filtration industry, we believed we could adapt to supply the filter media used in the […]
Report: Abbott to hire 2,000 in Illinois to make rapid COVID-19 test
Abbott (NYSE:ABT) is reportedly set to hire 2,000 new employees to increase manufacturing for its rapid COVID-19 test. The Chicago Sun-Times reported last week that the Abbot Park, Ill.-based company would be adding jobs at its Gurnee, Ill., facility following the FDA emergency use authorization (EUA) for its BinaxNow COVID-19 Ag Card and the subsequent announcement […]
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