Moderna (NSDQ:MRNA) announced today that it submitted for full FDA approval of its mRNA COVID-19 vaccine for individuals 18 years of age and older. Cambridge, Mass.-based Moderna initiated the rolling submission process with the FDA for a Biologics License Application (BLA) to license its mRNA COVID-19 vaccine, according to a news release. The move mirrors […]
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.
Abbott stock down on reduced 2021 earnings outlook
Abbott (NYSE:ABT) announced today that it is cutting its earnings outlook for the year amid reduced demand for COVID-19 diagnostics. The news sent ABT shares down more than 8% to $106.91 apiece by midday trading today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down slightly. Abbott had […]
U.K. authorizes J&J COVID-19 vaccine
The United Kingdom announced that it approved the single-dose COVID-19 vaccine developed by Johnson & Johnson’s Janssen Pharmaceutical business. The Medicines and Healthcare products Regulatory Agency (MHRA) granted the regulatory approval, making Janssen’s the fourth COVID-19 vaccine authorized by the independent regulator and the first to be approved as a single-dose option, according to a […]
FDA shifts gears as mask shortages ease
The FDA wants healthcare providers to move away from using certain imported disposable masks, such as KN95s. The recommendation to ease off using non-NIOSH-approved masks comes less than two months after the agency said providers could transition away from reusing decontaminated masks. Get the full story on our sister site, Medical Design & Outsourcing.
Honeywell lays off nearly 500 on Rhode Island N95 production line
Honeywell is laying off approximately 470 employees on its Smithfield, R.I.-based N95 respirator mask production line. Charlotte, N.C.-based Honeywell expanded operations at the Smithfield eye protection products plant so that the facility could also manufacture millions of N95 masks at the beginning of the pandemic in March 2020. Get the full story at our sister site, […]
Barclays is bullish on medtech
A Barclays analysis projects that medtech might be on its way to a stretch of “outperformance” even in the wake of the COVID-19 pandemic. According to SeekingAlpha, the report cited eight reasons that make the investment bank bullish on the industry in the coming years, starting with what it calls “robust innovation.” On top of […]
COVID-19 lab-leak theory re-emerges as U.S. intelligence report surfaces
A previously undisclosed U.S. intelligence report revealed that three scientists from China’s Wuhan Institute of Virology became sick enough in November 2019 to seek hospital care, according to the Wall Street Journal. The illnesses were consistent with both COVID-19 and common seasonal illnesses, but the report fuels speculation that the scientists at the Wuhan lab were among […]
MedTech 100 roundup: More growth ahead?
A turgid month for the medtech industry might be drifting into the past after the past week indicated a slight turnaround as summer nears. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week at 107.74 points, marking a 1.4% rise from the 106.22-point mark set one […]
Eurofins gains EUA for young children’s COVID test
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 […]
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 […]
