Haemonetics (NYSE:HAE) announced that it acquired next-generation whole blood coagulation testing system developer Enicor GmbH for an undisclosed amount. Munich, Germany-based Enicor develops the ClotPro system designed for viscoelastic diagnostics touted to offer more assays than any other hemostasis analyzer on the market. Haemonetics said in a news release that ClotPro is set to be coupled […]
CDC weighs DIY facemasks for the general public. Here’s the science behind mask materials.
Lee Teschler, Executive Editor, DesignWorld It looks as though the U.S. Centers for Disease Control and Prevention (CDC) may end up strongly suggesting that Americans cover their faces in public until the coronavirus pandemic plays out. The Washington Post reports the recommendations now being floated would call for the use of cloth coverings instead of hard-to-find […]
BD to launch point-of-care COVID-19 antibody test
Becton Dickinson (NYSE:BDX) yesterday announced a new point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19 in as little as 15 minutes. The new test, developed and manufactured by BioMedomics (Morrisville, N.C.), will be available through BD and distributed exclusively by Henry Schein (NSDQ:HSIC) to healthcare providers throughout the […]
Worcester Polytechnic Institute working on open-source ventilator designs
Researchers at Worcester (Mass.) Polytechnic Institute (WPI) are touting a design for turning inexpensive bag valve mask (BVM) resuscitators into automated ventilators to aid the fight against the coronavirus outbreak. The WPI team is designing the ventilators from readily available, manual BVM resuscitators so that they can fill the gap between the number of ventilators […]
FDA to authorize single-laboratory COVID-19 tests
The FDA said yesterday it will consider emergency use authorization (EUA) for molecular COVID-19 diagnostic tests to be used solely in the laboratories that developed them. The laboratories must be certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity tests. The tests must either be new or represent a significant deviation […]
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 […]
Factory CRO Group rebrands as Avania
Medtech contract research organization Factory-CRO Group is changing its name to Avania. Formed Boston-based Boston Biomedical Associates (Marlborough, Mass.), Factory CRO (Bilthoven, Netherlands), Five Corners (Artarmon, Australia), and MileStone Research Organization (San Diego), Avania said it will bring together regional teams of experts across a wide range of therapeutic specialties, including medical devices, novel technology, […]
Study tests proven blood clot buster against COVID-19
While vaccines and pharmaceutical treatments for COVID-19 might be far off, researchers at the Massachusetts Institute of Technology and University of Colorado are exploring a stopgap measure that could buy time for critically ill patients, according to a news release by the two institutions. In a clinical trial being planned for hospitals in Massachusetts and […]
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 […]
Moody’s lowers outlook for U.S. medtech industry due to coronavirus
Moody’s Investors Service has lowered its outlook for the U.S. medical device industry due to lower sales it expects from the coronavirus outbreak. The Wall Street ratings service said yesterday that it has revised its EBITDA forecast for the next 12 to 18 months to 2% to 4% from 5% to 6%, but added that […]
FDA lets states approve COVID-19 tests
The FDA has issued an unprecedented new guidance that allows individual states to approve diagnostic tests for COVID-19. The guidance also describes a policy regarding the use of serological testing for antibodies to the virus without an emergency use authorization (EUA). The new guidance allows commercial manufacturers to more rapidly distribute their validated SARS-CoV-2 diagnostics […]
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