LumiraDx announced today that it received FDA emergency use authorization (EUA) for its LumiraDX SARS-CoV-2 point-of-care antigen test. London-based LumiraDx’s test is designed to detect antigen nucleocapsid protein from a nasal swab and provide results in less than 12 minutes from sample application in symptomatic patients, according to a news release. In clinical studies, the […]
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.
A promising drug for COVID-19 survival?
Researchers at Hackensack Meridian Health are touting the drug tocilizumab as a treatment for critically ill COVID-19 patients in the ICU. Observational data of hospitalized COVID-19 patients shows that tocilizumab, generally used to treat rheumatoid arthritis and cancer, improves hospital survival in the critically ill ICU patients, according to a news release. Get the full […]
CUNY med school, TechnoVax report COVID-19 vaccine breakthrough
The CUNY School of Medicine at The City College of New York and TechnoVax announced a breakthrough in developing a COVID-19 vaccine. Scientests from the collaborating organizations said in a news release that they have generated and characterized SARS-CoV-2 virus-like particles, which are structural mimics of the native virus in size, morphology and surface composition, […]
Congressional leaders want more info on COVID supply chain
Leaders in both houses of Congress want federal trade officials to further investigate the supply chain for COVID-19-related goods and devices, but don’t expect any answers before December. Members of the House Ways and Means and Senate Finance committees wrote a letter to U.S. International Trade Commission (USITC) chairman Jason Kearns last week, asking for a more […]
Accelerate Diagnostics gains EUA for rapid coronavirus antibody test
Accelerate Diagnostics (NSDQ:AXDX) and BioCheck announced that they received FDA emergency use authorization for their COVID-19 antibody test. The BioCheck SARS-CoV-2 IgM and IgG combo test and fully-automated MS-Fast instrument that received authorization can process human serum samples in 30 minutes to detect antibodies that indicate recent or prior COVID-19 infection, according to a news […]
Alcon slides on missed Q2 earnings
Alcon (NYSE:ALC) shares dipped before hours today on second-quarter results that missed the consensus earnings forecast. The Geneva, Switzerland-based company posted losses of -$422 million, or -86¢ per share, on sales of $1.2 billion for the three months ended June 30, 2020, for an 8.2% bottom-line slide on a sales decline of -36.2%. Adjusted to exclude […]
Medtech stocks help boost S&P rally
Medtech stocks helped the S&P 500 Index reach record highs today amid a bounceback from the lows of the COVID-19 pandemic. Reuters reported that medtech played its part in the record turn of the market, with Abiomed (NSDQ:ABMD), Regeneron Pharmaceuticals (NSDQ:REGN) and West Pharmaceutical Services (NYSE:WST), all of which are involved in developing COVID-19 therapeutics, all rising more […]
CMS pushes for return to essential kidney treatments, transplants
The Centers for Medicare & Medicaid Services (CMS) has announced updated guidance urging for the resumption of kidney procedures. CMS said its guidance is designed to ensure medical providers can able return to offering essential surgical, life-sustaining procedures while reinforcing infection control precautions at dialysis facilities in COVID-19 hotspots. The guidance includes a checklist of […]
NIH puts $4.3M into convalescent plasma trial for COVID-19 treatment
The National Institutes of Health today awarded the Albert Einstein College of Medicine and Montefiore a $4.3 million grant to test plasma in treating COVID-19. Einstein and Montefiore launched a Phase 2 clinical trial to evaluate the efficacy of convalescent plasma in treating COVID-19 in April. The $4.3 million will support the randomized, double-blind, placebo-controlled […]
Labor unions, environmental groups demand federal action on PPE
A group of labor unions and environmental organizations is petitioning the Trump Administration to mandate production of personal protective equipment (PPE) using the Defense Production Act. The petition, submitted Aug. 11 to the U.S. departments of Health and Human Services and Homeland Security, dovetails with the FDA’s issuance on Monday of its first list of PPE shortages, […]
Report: Ventilators are piling up in government stockpiles
As the COVID-19 pandemic roars on, the government stockpile of once-in-demand ventilators has reportedly turned into a collection of unused devices. The Washington Post reports that, following the panic caused by an anticipated ventilator shortage and subsequent rush to add to the stockpile after President Trump invoked the Defense Production Act, the approach to treating COVID-19 […]