The coronavirus pandemic has cast a spotlight on U.S. reliance on pharmaceuticals made in China, with the Trump administration reportedly considering actions to increase demand for American-made drugs and medical products. The executive order in coming days would likely close loopholes that allow the federal government to buy foreign-made pharmaceutics and medical devices, The New […]
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.
Johnson & Johnson: Clinical study of potential coronavirus vaccine could start by end of year
Johnson & Johnson (NYSE:JNJ) said today that its Janssen Pharmaceutical Cos. has forged a partnership with the Beth Israel Deaconess Medical Center (BIDMC) to support coronavirus vaccine development. Janssen and the virology lab led by Dr. Dan Barouch at BIDMC have started preclinical testing of multiple vaccine prospects, with the goal of identifying a COVID-19 […]
Roche secures emergency use authorization for coronavirus test
Roche (SWX: RO, ROG) announced today that its Cobas SARS-CoV-2 test is the first commercially distributed diagnostic test to receive an FDA emergency use authorization during the coronavirus pandemic. The tests are also now available in countries accepting the EU’s CE Mark. FDA didn’t object to Roche pre-positioning its test, so labs are now able to initiate testing […]
Trump orders more general use respirators for healthcare workers
Amid the COVID-19 pandemic sweeping the globe, President Donald Trump issued an executive order to increase the availability of personal respiratory devices for healthcare workers. In a memorandum released by the White House on March 10, Trump declared that public health experts anticipate shortages in the supply of respirators available for use by healthcare workers […]
FDA asks manufacturers to help prevent protective gear shortages
The FDA said today it wants to hear from surgical mask and gown manufacturers that might be able to increase or speed production to prevent shortages in the U.S. during the COVID-19 outbreak. The agency said it may expedite review of manufacturing site changes or premarket submissions of personal protective equipment, including protective clothing, gowns, […]
Medical device companies continue to scale back sales projections amid coronavirus
Add ConMed (NSDQ:CNMD) to the list of medical device companies scaling back performance projections amid the coronavirus pandemic. The Utica, N.Y.–based minimally invasive surgical device and equipment maker said yesterday that it now expects Q1 2020 revenue growth in the 2–4% range, versus the company’s previous 5–6% guidance. The company also expects a favorable tax […]
Report: Some hospitals running short of 3M’s N95 masks amid coronavirus outbreak
Some U.S. hospitals are facing short supplies of N95 respirator masks from 3M (NYSE:MMM) as the global coronavirus outbreak ramps up, according to a report in The New York Times. “I can tell you my other colleagues across our multiple hospitals are really rationing,” Dr. Susan Ray, an infectious disease specialist at Grady Memorial Hospital in […]
BREAKING: FDA postponing all foreign inspections amid coronavirus outbreak
The U.S. FDA said today that it is postponing foreign inspections through April as the coronavirus outbreak continues to worsen around the world. The agency already halted medical device plant inspections in China, where the virus originated. Dr. Stephen Hahn, the FDA’s commissioner, said in a statement that the agency came to its latest decision […]
Hologic gets U.S. funding for coronavirus test kit
The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) is offering advanced development support to Hologic (NSDQ:HOLX) for a molecular diagnostic test for coronavirus (COVID-19). Marlborough, Mass.-based Hologic’s test is the first coronavirus product selected for development through ASPR’s biomedical advanced R&D authority streamlined selection process (BARDA), […]
Medical device company stocks aren’t immune from coronavirus
Major U.S. medical device company stocks have generally performed as poorly as others over the past two weeks as the global coronavirus outbreak drive markets down. Among 20 of the largest U.S. companies on Medical Design & Outsourcing and MassDevice‘s annual Big 100 list, both the average and median decline in price was roughly 17% […]
President Trump signs $8.3b coronavirus emergency funding bill
President Donald Trump today signed an $8.3 billion emergency package to help address the ongoing outbreak of COVID-19, which is caused by the coronavirus. According to a report by Politico, about $7.7 billion of that $8.3 billion is slated for discretionary spending to improve vaccine development, research, equipment stockpiles and both state and local health budgets. […]
