Dentsply Sirona (NSDQ:XRAY) shares dipped today despite preliminary first-quarter results that topped the consensus forecast. The Charlotte, N.C.-based company posted losses of -$139.9 million, or -63¢ per share, on sales of $874.3 million for the three months ended March 31, 2020, for a bottom-line slide from profits of $39.2 million this time last year on a […]
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.
Zoll Medical hit with dozens of COVID-19 cases
Zoll Medical‘s Pawtucket, R.I. facility — which manufacturers parts for ventilators and defibrillators — has seen 75 cases of COVID-19, according to a report in The Providence Journal. Zoll learned of the outbreak in late March, sending all the plant workers home April 2–6 as it cleaned the facility and reoriented the workspace, Zoll Medical […]
Biomerica wins CE Mark for high-volume, 10-minute COVID-19 test
Biomerica (NDSQ:BMRA) announced that it received CE Mark and is launching a high-volume production version of its COVID-19 rapid test. Irvine, Calif.-based Biomerica’s IgG/IgM rapid test uses the finger-prick method to test blood with results obtained within 10 minutes. The test can be performed by trained professionals anywhere. The company’s new high-volume version of the […]
FDA authorizes at-home collection for Rutgers’ saliva-based COVID-19 test
FDA announced today that it has expanded the previous EUA it granted for the saliva-based COVID-19 test out of Rutgers University — allowing people to collect samples at home and return the samples to the Rutgers Clinical Genomics Laboratory in a sealed package for testing. The news comes just weeks after FDA authorized an at-home COVID-19 […]
FDA warns of color-coding problem when sterilizing N95 masks
The FDA is warning that a problem is cropping up as health providers use hydrogen peroxide sterilization to reuse N95 respirators amid the COVID-19 pandemic: There’s no standard color to show the process worked. Specifically, staff at hospitals are facing a pink versus blue problem. The 3M Comply Hydrogen Peroxide Chemical Indicator 1248 uses blue […]
Abbott touts study showing nearly 100% accuracy of its COVID-19 antibody test
Abbott (NYSE:ABT) today highlighted University of Washington research showing that its COVID-19 blood antibody test had 99.9% specificity and 100% sensitivity among people tested 17 days after the start of symptoms. Abbott has already shipped more than 10 million of the SARS-CoV-2 IgG lab-based serology blood tests around the world for use on the company’s Architect […]
FDA yanks 60 Chinese companies’ respirators from emergency use list
The FDA has removed respirators made by 60 companies in China from its emergency use authorization (EUA) list for COVID-19 over concerns that they may be “sub-standard.” The list, which had totaled 74 manufacturers when issued April 24, still includes 15 models of N95 respirators made in China by 3M (NYSE:MMM), plus a number of models […]
BD ramping up testing capacity for possible second wave of COVID-19
Becton Dickinson is preparing to scale up its manufacturing operations of COVID-19 testing kits for a second wave of infections in the fall, according to Reuters. Franklin Lakes, N.J.-based BD in April received FDA emergency use authorization (EUA) and CE mark approval for its COVID-19 test that returns results in 2-3 hours. The test is […]
3M wins federal contracts to further expand U.S. respirator production
3M (NYSE:MMM) announced today that it received two more U.S. Department of Defense contracts to further expand its domestic production of N95 respirator masks. Since January, the Maplewood, Minn.-based company has doubled its global output of respirators to 1.1 billion per year, with 35 million N95 masks produced per month in the U.S. According to a […]
TransMedics slides on mixed Q1
TransMedics (NSDQ:TMDX) shares took a slight dip today on first-quarter results that came up mixed compared to the consensus forecast. The Andover, Mass.-based company posted losses of -$8.9 million, or -42¢ per share, on sales of $7.5 million for the three months ended March 31, 2020, for a 28.4% bottom-line slide on sales growth of 61%. […]
Invacare up on mixed bag Q1
Invacare (NYSE:IVC) shares ticked up today on first-quarter results that saw earnings top the consensus forecast despite reduced revenues. The Elyria, Ohio-based medical equipment maker posted profits of $732,000, or 2¢ per share, on sales of $218.4 million for the three months ended March 31, 2020, for a bottom-line return to profits on a sales decline […]