Medtronic (NYSE:MDT) announced fourth-quarter results today that were even worse than expected, but the world’s largest medical device company is still upping its dividend and investing in future growth. The Fridley, Minn.–based medtech giant reported profits of $646 million, or $0.48 per share, on sales of $6.0 billion for the three months ended April 24, 2020, […]
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.
This patient-mover got an emergency COVID-19 nod from the FDA
AR Tech, a division of A&R Tarpaulins, announced today that the FDA has granted an EUA for its Patient Isolation Transportation Unit (PITU) to help hospitals better manage the COVID-19 pandemic. “PITU is a game-changer in this fight against the pandemic because it is a negative pressure isolation enclosure that makes working with highly contagious […]
FDA approves Phase 3 trial for coronavirus drug
Octapharma announced today that the FDA approved its investigational new drug (IND) application for a Phase 3 clinical trial for its drug therapy in COVID-19 patients. Octagam 10% [Immune Globulin Intravenous (Human)] therapy will be observed for efficacy and safety in use with COVID-19 patients with severe disease progression, according to a news release. Get the […]
G Medical Innovations ECG Patch receives FDA EUA for use in COVID-19 patients
G Medical Innovations recently announced that it received FDA emergency use authorization for its vital signs monitoring system ECG patch for remote monitoring of patients who are being treated for COVID-19. The patch monitors the QT interval of an ECG in patients to watch for fatal arrhythmias that may occur from treatment drugs. Prolonged QT […]
Bio-Techne, Kantaro Biosciences to produce COVID-19 serology test
Bio-Techne (NSDQ:TECH) and Kantaro Biosciences announced a partnership to manufacture and distribute COVID-19 serology tests. Kantaro, a commercial affiliate of the Mount Sinai Health System in New York, will collaborate with Bio-Techne to develop a test kit based on the Mount Sinai-developed coronavirus test and scale the manufacturing and distribution of those kits. The companies […]
Phlow lands $354m government contract for COVID-19 medications
Phlow announced today that it received $354 million in U.S. government funding to manufacture essential medicines at risk of shortage, including those involved in the COVID-19 pandemic response. Richmond, Va.-based Phlow’s manufacturing is being funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of Assistant Secretary for Preparedness and Response (ASPR) […]
Groups release guidance on medtech reps’ return to hospitals
A handful of medical organizations released guidelines today on the safe return of medtech company representatives to healthcare facilities during the coronavirus pandemic. The guidance released today by AdvaMed, the Association of periOperative Registered Nurses (AORN) and the American Hospital Association (AHA) builds on the April 17 joint statement by AHA, AORN, the American College […]
Moderna prices $1.3b public offering following positive COVID-19 vaccine results
Shortly after touting positive results from its COVID-19 vaccine candidate, Moderna announced the pricing of an offering of 17.6 million shares of its common stock. The Cambridge, Mass.-based clinical-stage biotechnology company announced yesterday that it received positive interim clinical data from trials for its mRNA-1273 vaccine candidate against coronavirus (SARS-CoV-2). Moderna’s underwritten public offering, announced […]
Moderna reports positive early data out of COVID-19 vaccine trial
Moderna today touted positive interim clinical data from trials for its mRNA-1273 vaccine candidate against coronavirus (SARS-CoV-2). The Phase I study, led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), recorded positive early results from the first eight people tested, each of whom received two […]
Beckman Coulter awarded expanded contract for sepsis algorithm
Beckman Coulter announced that it received an expanded partnership with BARDA for its expanding COVID-19 medical countermeasure portfolio. BARDA (the Biomedical Advanced Research and Development Authority, part of the U.S. Dept. of Health and Human Services) awarded Beckman Coulter the partnership in collaboration with Dascena, Inc. The collaboration will offer advanced research and development toward […]
FDA authorizes at-home COVID-19 test kit
The FDA announced that it issued emergency use authorization for Everlywell’s at-home sample collection kit for COVID-19 diagnostic testing. Everlywell’s kit has authorization for use by individuals at home who have been screened using an online questionnaire that is reviewed by a healthcare provider. The collection kit can then be sent to specified laboratories for […]
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