Fujifilm (TSE:4901) is spending big to double the size of its United Kingdom-based vaccine manufacturing facility. According to a news release, Fujifilm is spending about $532.8 million (£400 million) to expand its Teesside (north-east England) plant making the Novavax COVID-19 vaccine. The expansion includes facilities specializing in antibody treatments and viral gene therapies. Fujifilm said […]
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.
FDA’s Woodcock reassures about COVID-19 tests, vaccines under Omicron
Acting FDA Commissioner Dr. Janet Woodcock thinks many COVID-19 tests will continue to work with the new Omicron variant — with information coming soon on vaccine efficacy. In a statement posted yesterday, Woodcock said she thought the agency is well-positioned to work with companies to address the potential impact of viral mutations on COVID-19 tests, […]
COVID-19 test makers say their products also detect Omicron
Abbott, BD, Hologic, PerkinElmer and Thermo Fisher are reassuring the public that their COVID-19 tests detect the Omicron variant. Discovered last week in South Africa, the new variant has enough mutations that it has raised concerns worldwide — even though it is still unknown for sure whether the mutations cause greater transmissibility or vaccine evasion. […]
Thermo Fisher says TaqPath tests can detect Omicron variant of COVID-19
Thermo Fisher Scientific (NYSE:TMO) said today that its TaqPath diagnostic kit can detect the emerging Omicron variant of COVID-19. Waltham, Massachusetts-based Thermo Fisher’s polymerase chain reaction (PCR) TaqPath COVID-19 Combo Kit and TaqPath COVID-19 CE-IVD RT-PCR Kit, which test for the presence of SARS-CoV-2 (the virus causing COVID-19), offer accurate results for samples with the […]
Pfizer and Moderna keeping a close watch on Omicron COVID-19 variant
Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) are planning to research their vaccines’ effectiveness against the highly mutated Omicron variant (B.1.1.529), which is behind a surge in infections in Johannesburg, South Africa. If needed, they plan to create new versions of their vaccines. The Omicron variant has more than 30 changes to the SARS-CoV-2 spike protein. “I […]
Time recognizes Abbott offerings among this year’s 100 best inventions
Abbott (NYSE:ABT) was among a series of medtech companies to receive recognition from Time in its list of 2021’s best inventions. The list of the year’s top inventions included Abbott’s innovations twice, with a nod to its NeuroSphere Virtual Clinic and its at-home COVID-19 testing offerings. Get the full story at our sister site, Medical Design & Outsourcing.
Ellume’s at-home COVID-19 tests recall expands to more than 2 million
The FDA announced this week that a recall of Ellume at-home COVID-19 tests at risk of false positives has expanded to include more than 2 million. The Class I recall had only been in the hundreds of thousands of kits when first announced in October. The Australian company has stressed that the reliability of negative […]
World faces a shortage of up to 2 billion COVID-19 vaccine syringes
The World Health Organization (WHO) reportedly warned that a massive shortage of syringes for COVID-19 vaccines could be on the horizon. Reuters reported that WHO expert Lisa Hedman told a United Nations briefing that the potential shortage of 1 billion to 2 billion syringes could slow down routine immunizations and create issues with needle safety along […]
Moderna takes big hit on missed Q3 projections
Moderna (NSDQ:MRNA) shares took a big hit today on third-quarter results that came up short of the consensus forecast. MRNA shares were down 17.1% at $286.80 per share in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 0.2%. Get the full story at our […]
BD ticks up on Street-beating Q4, sets 2022 guidance range
BD (NYSE:BDX) shares rose today on fourth-quarter results that came in ahead of the consensus forecast. The Franklin Lakes, New Jersey-based medtech posted profits of $242 million, or 84¢ per share, on sales of $5.1 billion for the three months ended Sept. 30, 2021, more than doubling its bottom line on sales growth of 7.3%. […]
Detect wins FDA authorization to sell COVID-19 test over the counter
Detect announced today that it received FDA emergency use authorization (EUA) to sell its COVID-19 test over the counter. Guilford, Connecticut-based Detect develops a molecular rapid test designed to identify SARS-CoV-2, the virus causing COVID-19, at lower viral loads than antigen tests to allow for earlier detection, according to a news release. The Detect COVID-19 […]