Becton Dickinson (NYSE:BDX) announced today that it received CE Mark for and launched its immune assessment product for COVID-19 patients. The BD Multitest 6-color TBNK reagent with BD Trucount tubes received the European regulatory approval with expanded clinical application for the identification and enumberation of T-cell subtypes in COVID-19 patients to help inform the clinical course […]
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.
Pfizer expects to apply for COVID-19 vaccine EUA in late November, CEO says
Pfizer (NYSE:PFE) chairman & CEO Albert Bourla penned an open letter today setting an expected timeline for the company’s COVID-19 vaccine candidate. The vaccine candidate, being developed in collaboration with BioNTech (NSDQ:BNTX), is among the top COVID-19 vaccines currently undergoing Phase 3 clinical trials and nearing potential regulatory authorization, should they prove safe and effective. Once the company […]
The top 5 MassDevice stories of the week — October 16, 2020
For the second consecutive week, medtech giant Medtronic (NYSE:MDT) managed to dominate the news on MassDevice. The company’s “Investor Day” brought about several headlines, including new clinical trials ahead and a rallying cry from CEO Geoff Martha. Other news that garnered some attention came in the form of a new ultrasound system from another big player […]
Sanofi to launch COVID-19 vaccine trial in Q4
Sanofi (NYSE:SNY) and Translate Bio (NSDQ:TBIO) announced today that a Phase 1/2 clinical trial for its COVID-19 vaccine candidate is set for the fourth quarter of 2020. Preclinical results for MRT5500, the COVID-19 vaccine candidate under development by the two companies, demonstrated a favorable immune response profile against SARS-CoV-2, the virus causing coronavirus, which supports the selection […]
Medtronic CEO Geoff Martha: ‘Time to be bold and add grit’
Medtronic (NYSE:MDT) CEO Geoff Martha has no intention of slowing the medtech giant down amid the COVID-19 pandemic. Speaking during the Fridley, Minn.-based company’s “Investor Day” virtual presentation, Martha made one thing clear: “We are going on the offensive,” Martha said at the start and echoed throughout the program. About six months into his tenure as […]
Cue Health lands $481M from HHS for COVID-19 test
The federal government has awarded startup Cue Health $481 million to increase domestic production capacity of point-of-care testing for COVID-19. The money from the Department of Health and Human Services and the Department of Defense will enable San Diego, Calif.-based Cue to manufacture 100,000 COVID-19 test kits per day by March 2021, including 6 million […]
Report: Eli Lilly halts COVID-19 treatment trial
Eli Lilly (NYSE:LLY) reportedly paused a clinical trial testing its COVID-19 antibody treatment candidate because of a “potential safety concern.” The New York Times reported that Eli Lilly’s testing site researchers were notified of the pause by emails sent by government officials (it is a government-sponsored trial) and the company later confirmed it. A spokesperson from the […]
Vaccine trial pause sees Johnson & Johnson dip despite strong Q3
Johnson & Johnson (NYSE:JNJ) shares ticked down despite third-quarter results that came in well ahead of the consensus forecast. News of the company’s COVID-19 vaccine candidate trial being put on pause after a patient illness likely played its part, as shares of JNJ were trading down -2.1% at $148.68 per share in midday trading today. The […]
J&J halts COVID-19 vaccine trial due to illness
Johnson & Johnson (NYSE:JNJ) announced that it temporarily paused further dosing in its COVID-19 vaccine candidate clinical trials. The pause in the trials conducted by J&J’s Janssen Pharmaceuticals subsidiary follows an unexplained illness arising in a study participant, according to a news release. Under the company’s guidelines, the illness is being reviewed and evaluated by internal and independent […]
Abbott wins FDA EUA for COVID-19 IgM antibody test
Abbott (NYSE:ABT) announced that it received FDA emergency use authorization (EUA) for its IgM antibody serology test for COVID-19. The AdviseDx SARS-CoV-2 IgM lab-based serology test runs on the Architect and Alinity platforms to detect antibodies in response to the virus, indicating a recent or prior infection. Abbott Park, Ill.-based Abbott’s latest test is the company’s […]
MedTech 100 roundup: New peak for industry
Stocks in the medtech industry continue to impress as, over the past week, they set a new benchmark amid the COVID-19 pandemic. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 95.05 (Oct. 9), marking a 5.9% gain from the 89.73 points registered at the […]