Ex-Theranos CEO Elizabeth Holmes lost a bid to have the trial in her criminal fraud case delayed, despite pleas of hardship due to the COVIDd-19 outbreak. According to published reports, Holmes’ defense attorneys argued yesterday that travel and other restrictions related to the pandemic would hamper their client’s trial preparation efforts. They had filed motions […]
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.
Siemens Healthineers seeking EUA for its coronavirus test kit
Siemens Healthineers (ETR: SHL) announced today that it is making its Fast Track Diagnostics (FTD) test kit for COVID-19 available as it seeks FDA emergency use authorization (EUA) and other forms of regulatory approval. The FTD SARS-CoV-2 assay kit is designed to diagnose infection by the SARS-CoV-2 virus that causes coronavirus. Siemens Healthineers is already shipping test […]
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 […]
Nemaura Medical repurposes its CGM to spot coronavirus fevers
Nemaura Medical (NSDQ:NMRD) announced today that it is planning to immediately repurpose its SugarBeat continuous glucose monitor (CGM) as a continuous temperature monitor (CTM) to help diagnose fevers in potential cases of COVID-19. The Loughborough, England-based company said in a news release that its inbuilt temperature sensor is capable of continuously tracking body temperature through the […]
U.S. ventilator manufacturing is rapidly expanding: Here’s how
Amid a shortage of life-saving ventilators due to the coronavirus pandemic, medical device companies are rapidly expanding production, trade group AdvaMed reported today. Respiratory device companies that belong to AdvaMed have boosted ventilators production to 2,000–3,000 per week — and expect to soon reach 5,000–7,000 ventilators per week. Last year, the same companies were making […]
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 […]
Chembio, Molecule Holdings launch fingerstick COVID-19 tests
Chembio Diagnostics and Molecule Holdings announced the launch of their separate COVID-19 serological point-of-care tests for detecting antibodies associated with coronavirus. Chembio’s fingerstick-style test using its MicroReader 1 and MicroReader 2 analyzers is designed to detect IgM and IgG antibodies and offer results within 15 minutes, according to a news release. Chembio (Medford, N.Y.) said […]
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 […]
Masimo withdraws 2020 guidance due to COVID-19
Masimo (NSDQ:MASI) announced today that it is updating its preliminary product revenue range for the first quarter but withdrawing its full-year 2020 guidance as a result of the COVID-19 pandemic. The Irvine, Calif.-based non-invasive monitoring technology developer anticipates product revenue in the first quarter of 2020 to range between $265 million and $271 million, reflecting growth […]
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 […]
How is the coronavirus affecting medtech events?
The coronavirus (COVID-19) outbreak has swept the globe and made a huge impact in the medtech space — especially when it comes to the events that provide a crucial networking and innovation-sharing function. The March 5 cancellation of the Healthcare Information and Management Systems Society (HIMSS) 2020 Global Health Conference & Exhibition was one of […]
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