Pfizer and BioNTech have asked the FDA to extend the emergency use authorization of their COVID-19 vaccine to adolescents ages 12 to 15, and acting FDA Commissioner Janet Woodcock said the request would be reviewed "as expeditiously as possible." The companies announced last month that clinical trial results showed the vaccine was safe and effective, and that it generated strong antibody responses in the age group.
Tokyo-based firm Olympus has opened its new global headquarters for its therapeutic solutions division in Westborough, Mass. "The U.S. market continues to be the largest in the world because of growing demand for minimally invasive treatment and surgery and the need for remote collaboration under COVID-19, so it's natural that we decided to combine all functions in Massachusetts in one place to facilitate agility and collaboration," said Nacho Abia, Olympus' chief operating officer.
Austin, Texas-based Luminex will be acquired by Italian Diagnostics firm DiaSorin in a deal worth approximately $1.8 billion. "Luminex perfectly fits with our strategy to grow our positioning in the molecular diagnostics space," said DiaSorin CEO Carlo Rosa.
NASA will begin testing Variable's E-Nose COVID-19 screening device, a handheld device that is designed to detect signature volatile organic compounds in the breath of people who have been infected with SARS-CoV-2. "Once the clinical trials are completed and the sensitivity and specificity are demonstrated, E-Nose can be deployed in factories, airports, grocery stores, and businesses of all sorts to rapidly screen for active infections," said Jing Li, the NASA scientist who invented the nanosensor technology used by the device.
Lucira Health is reporting that its COVID-19 All-In-One Test Kit, a molecular diagnostic COVID-19 test, is able to detect the double mutant variant of SARS-CoV-2.
European regulators have given CE mark approval to AnteoTech for its EuGeni Reader and EuGeni COVID-19 Antigen Rapid Test that has a 99.6% specificity and 97.3% sensitivity.
The European Medicines Agency is investigating four serious incidents of "unusual blood clots with low blood platelets" linked to Johnson & Johnson's COVID-19 vaccine, which led to one death. In the US, Colorado-based health system Centura Health and North Carolina's UNC Health temporarily halted administration of J&J's vaccine after a small number of people experienced adverse reactions.
A Class I recall has been issued for Medtronic's Valiant Navion thoracic stent graft system.
Australian Prime Minister Scott Morrison says his country is ordering 40 million doses of Pfizer's COVID-19 vaccine, double its original order, over concerns about clotting issues with AstraZeneca's vaccine. Health officials say the change is a precaution and are still advising residents over 50 to take the AZ vaccine.
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