Forcing manufacturers to repurpose their production lines to make equipment to fight the coronavirus epidemic might actually hurt the U.S. supply of those items, the head of medtech trade group AdvaMed said today. AdvaMed officials have talked with U.S. secretary of Health and Human Services Alex Azar and FDA commissioner Dr. Stephen Hahn about medtech […]
Thermo Fisher Scientific wins CE mark for COVID-19 test
Thermo Fisher Scientific (NYSE:TMO) announced that it received CE Mark approval in Europe for the use of its diagnostic test in detecting nucleic acid from the SARS-CoV-2 virus that causes COVID-19. The Waltham, Mass.-based company’s test uses Applied Biosystems’ TaqPath assay and real-time PCR technology. It is designed to provide results within four hours of a […]
Mologic starts validation of point-of-need coronavirus test
Mologic announced today that it initiated early validation of point-of-need COVID-19 diagnostic tests with two United Kingdom-based universities. The Bedfordshire, U.K.-based company is initiating its tests with the Liverpool School of Tropical Medicine and St. George’s University London, according to a news release. The accelerated development of the test is a product of funding from […]
Bardy Diagnostics’ patch could monitor coronavirus patients prescribed HCQ experimentally
Bardy Diagnostics says Seattle-area health providers are using its Carnation ambulatory monitor (CAM) patch to measure QT segments in COVID-19 patients prescribed hydroxychloroquine (HCQ) experimentally. Hospitals across the city in their protocals have slated the local company’s CAM patch for use monitoring cardiac rhythms after coronavirus patients on HCQ are discharged from the hospital, as […]
Ixlayer Launches COVID-19 testing platform
Ixlayer announced today that it is adapting its established testing platform for COVID-19-specific content and user flows to allow for quick connection in the delivery of coronavirus testing. The San Francisco-based company said its platform already encompasses complex security components and is now adapted to the coronavirus-related content and flows that allow physicians, health systems, […]
FDA warns against at-home COVID-19 tests
The FDA is warning consumers against unauthorized COVID-19 test kits marketed for use in the home. The agency said it has not authorized any diagnostic test for the virus for at-home use, nor has it endorsed any prevention or treatment claims that individual companies have made. The FDA also said it is not naming any […]
Thermo Fisher lines up financing for Qiagen buy
Thermo Fisher Scientific (NYSE:TMO) confirmed in a prospectus supplement that it is in part financing its $11.5 billion purchase of Qiagen (NYSE:QGEN) with an offering worth $2.2 billion. The offering includes $1.1 billion in 4.133% senior notes due in 2025 and another $1.1 billion in 4.497% senior notes due in 2030. Thermo Fisher said in its prospectus […]
PerkinElmer secures FDA emergency use authorizaiton for COVID-19 tests
PerkinElmer (NYSE:PKI) announced that the FDA granted it emergency use authorization (EUA) for its new coronavirus RT-PCR test. The Waltham, Mass.-based company said in a news release that clinical laboratories that are certified under the Clinical Laboratory Improvement Amendments (CLIA) can now immediately begin using the kit to detect the SARS-CoV-2 virus that causes COVID-19. PerkinElmer […]
SGI-DNA touts its automated gene printer for coronavirus vaccine development
Synthetic biology company SGI-DNA is touting its efforts to accelerate research in the creation of vaccines for SARS-CoV-2, the virus causing the COVID-19 pandemic. The San Diego-based company said in a news release last month that it built the genes thought to be critical to developing successful vaccines against the virus and made those tools available as […]
5 companies on the front lines of the coronavirus fight
Nancy Crotti, Managing Editor and Danielle Kirsh, Senior Editor Amid the stock market roller-coaster ride that began last month, medtech companies that make devices and diagnostic tests vital to fighting COVID-19 may ultimately fare better than others, but it’s hard to tell until the virus peaks and people get back to work. At midafternoon today, […]
Cepheid wins emergency use nod from FDA for bedside coronavirus test
Danaher Corp. (NYSE:DHR) subsidiary Cepheid announced that it received emergency use authorization from the FDA for its bedside Xpert Xpress SARS-CoV-2 test for detecting the virus causing the COVID-19 outbreak. The rapid molecular diagnostic test is designed to detect the SARS-CoV-2 virus causing coronavirus while operating on any of Cepheid’s GeneXpert systems worldwide, with a detection […]
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