Eurofins announced today that it received FDA emergency use authorization (EUA) for its at-home COVID-19 testing kit for children 3 years of age and older. Luxembourg-based Eurofins’ Clinical Enterprise subsidiary became the first to receive EUA for an at-home nasal PCR test for young children with the empowerDX kit, according to a news release. In […]
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.
BD to build $200M facility in Spain for pre-filled drug delivery device manufacturing
BD (NYSE:BDX) announced today that it will build a more than $200 million drug delivery device manufacturing facility in Spain. The approximately $201.5 million (€165 million) high-tech manufacturing facility in Zaragoza, Spain, is expected to create up to 600 jobs by 2030, according to a news release. Get the full story at our sister site, Drug […]
Cue Health raises $235M to support its over-the-counter, home-use diagnostics
Healthcare technology company Cue Health announced that it closed a private financing round worth $235 million. Existing investors Johnson & Johnson Innovation — JJDC, Decheng Capital, CAVU Ventures, ACME Capital and more contributed to the financing, as did new investors Perceptive Advisors, MSD Capital and Koch Strategic Platforms, according to a news release. Morgan Stanley […]
United, Abbott partner to use rapid COVID-19 test for international travel
United Airlines and Abbott announced a collaboration to use the latter’s BinaxNOW COVID-19 home test to make international travel more seamless. Recent CDC guidelines permit travelers to self-administer a rapid antigen test under the real-time supervision of a telehealth service and use the verified negative result to board an international flight to the U.S., according […]
How PhysIQ is advancing digital therapeutics through its partnership with Janssen
A partnership with J&J’s Janssen Pharmaceuticals is helping PhysIQ advance with its device-agnostic clinical data collection and analysis platform. Over the course of the last year and some change, the impact of digital health and the need for it has increased by an immeasurable amount. Virtual care became the norm after the COVID-19 pandemic hit, […]
FDA OKs Pfizer-BioNTech COVID-19 vaccine for younger adolescents
The FDA has authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) for adolescents as young as 12. The agency had previously authorized the vaccine for people 16 and older in December 2020. The FDA came to its decision after Pfizer demonstrated in a Phase 3 trial that the vaccine showed 100% efficacy in preventing symptomatic […]
MedTech 100 roundup: Largest slide for industry in 2021
The medtech industry’s 2021 performance has been all over the place and the past weekend highlighted its topsy-turvy nature. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — had been on the rise since the beginning of April, with its mark of 112.25 on April 16 representing an all-time best and […]
BREAKING: Biden administration calls for waiving IP protections for COVID-19 vaccines
U.S. Trade Representative Katherine Tai announced this afternoon that the Biden administration supports waiving IP protections for COVID-19 vaccines. “This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,” Tai said in the statement. Get the full story on our sister site Pharmaceutical Processing World.
Pfizer to seek FDA approval for COVID-19 vaccine, will seek authorization for kids above 2
Pfizer CEO Albert Bourla said the company will soon seek full FDA approval and authorization for further age groups for its COVID-19 vaccine. Speaking during the company’s first-quarter earnings call yesterday, transcribed by The Motley Fool, Bourla outlined the regulatory pathways that the company is pursuing for the vaccine it developed with BioNTech, which is […]
FDA could soon authorize Pfizer COVID-19 vaccine for younger adolescents
The COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) appears to be on the cusp of winning regulatory authorization for use in adolescents between the ages of 12 and 15, according to several media reports. FDA has authorized the vaccine for people aged 16 and up. In March, Pfizer submitted clinical trial results to FDA, suggesting the efficacy of the […]
FDA revokes Battelle mask decontamination EUA
The FDA has revoked its authorization for Battelle Memorial Institute to decontaminate used N95 respirators for healthcare workers. In a letter dated April 30, 2021, the agency said it revoked the EUA at Battelle’s request. The Columbus, Ohio-based research organization asked to withdraw the EUA for its Critical Care Decontamination System (CCDS) in an April 2 letter. […]
