FDA issues Emergency Use Authorization to Thermo Fisher
On Friday, the FDA issued the fourth COVID-19 diagnostic Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath COVID-19 Combo Kit. The FDA issued an EUA to Thermo Fisher for its diagnostic test within 24 hours of receiving the request. This is the second commercially distributed test to receive an EUA during the COVID-19 outbreak.
“This action today shows our agency’s dedication to working around the clock to review and authorize diagnostics during this public health emergency,” said FDA Commissioner Stephen M. Hahn, M.D. “We have been engaging with test developers and encouraging them to come to the FDA and work with us. Since the beginning of this outbreak, more than 80 test developers have sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process. Additionally, more than 30 laboratories have notified us they are testing or intend to…”
UPMC ready to test for coronavirus; first collection site opens
UPMC has developed a test for the novel coronavirus SARS-CoV-2, which causes COVID-19. UPMC will use this test to diagnose select, symptomatic cases. The health system plans to rapidly increase capacity at its central laboratory and, if there is a need, could test hundreds of patients per week in the near future, filling a critical gap before other commercial tests come online, the health system said. UPMC on Tuesday will begin directing patients with symptoms consistent with COVID-19 to a specimen collection site in Pittsburgh’s South Side neighborhood. The site is not open to the general public. Patients must have a physician referral approved by UPMC’s infection prevention team and an appointment to have their specimen collected for testing by either UPMC or public health authorities.
UPMC will later open additional specimen collection facilities in Harrisburg, Erie, Williamsport and Altoona, Pennsylvania, at an as-yet undetermined date after gaining experience with the South Side facility and after UPMC’s testing capacity increases…
Trump declares COVID-19 emergency, asks hospitals to activate emergency plans
President Donald Trump on Friday asked hospitals to activate their emergency preparedness plans and declared the COVID-19 outbreak a national emergency, which will allow HHS to give providers more flexibility.
“I’m also asking every hospital in this country to activate its emergency preparedness plan so that they can meet the needs of Americans everywhere,” Trump said.
The emergency declaration, in conjunction with the administration’s prior designation of COVID-19 as a public health emergency on January 31, frees up to $50 billion in federal disaster relief funding, Trump said, and provides the HHS secretary with more authority to waive some Medicare, Medicaid and Children’s Health Insurance Program (CHIP) requirements.
Trump highlighted that the HHS secretary will have authority to waive several requirements hospitals had voiced concerns about, including…
Federal Reserve cuts rates to zero and launches massive $700 billion quantitative easing program
The Federal Reserve, in light of the disruption that the coronavirus outbreak has caused, cut interest rates to essentially zero and launched a massive $700 billion quantitative easing program to shelter the economy from the effects of the virus. The new fed funds rate, used as a benchmark both for short-term lending for financial institutions and as a peg to many consumer rates, will now be targeted at 0% to 0.25% down from a previous target range of 1% to 1.25%, according to CNBC.
Facing highly disrupted financial markets, the Fed also slashed the rate of emergency lending at the discount window for banks by 125 basis points to 0.25%, and lengthened the term of loans to 90 days…
Wall Street set to crash again after Fed slashes rates
“Wall Street looked set to crater on Monday as fears of a coronavirus-driven recession intensified following a second emergency interest rate cut in a fortnight by the Federal Reserve.
S&P 500 futures EScv1 fell 4.77% to hit a daily down limit in early trading, and S&P 500 ETFs (SPY.P) plunged 9%, suggesting the benchmark index would set off a 15-minute cutout at 7% put in place to prevent another 1987 “Black Monday”-style crash.
“Central banks in the United States, Japan, Australia and New Zealand announced sweeping monetary easing in a co-ordinated effort not seen since the 2008 financial crisis, but failed to shore up global investor sentiment.
“The extent of the action, taken ahead of the Fed’s regularly scheduled meeting set for Tuesday and Wednesday, spooked investors following Wall Street’s attempt at a rebound on Friday as President Donald Trump declared a national emergency and earmarked $50 billion in…”
CDC recommends the cancellation or postponement of all events with 50 people or more for the next 8 weeks
The CDC, in accordance with its guidance for large events and mass gatherings, recommends that for the next 8 weeks, organizers (whether groups or individuals) cancel or postpone in-person events that consist of 50 people or more throughout the U.S. Large events and mass gatherings can contribute to the spread of COVID-19 in the United States via travelers who attend these events and introduce the virus to new communities. Examples of large events and mass gatherings include conferences, festivals, parades, concerts, sporting events, weddings, and other types of assemblies. These events can be planned not only by organizations and communities but also by individuals. Events of any size should only be continued if they can be carried out with adherence to guidelines for protecting vulnerable populations, hand hygiene, and social distancing. When feasible, organizers could modify events to be virtual…
Italian hospital saves Covid-19 patients lives by 3D printing valves for reanimation devices
One of the biggest immediate problems that coronavirus is causing is the massive number of people who require intensive care and oxygenation. 3D printing may be able to help.
Massimo Temporelli, founder of The FabLab (Milan, Italy), was told that the hospital in Brescia (near one of the hardest-hit regions for coronavirus infections) urgently needed valves for an intensive care device and that the supplier could not provide them in such a short time. His contact asked if it would be possible to 3D print them
After several phone calls to fablabs and companies in Milan and Brescia and then, fortunately, a company in the area, Isinnova, responded to the call for help through its Founder & CEO Cristian Fracassi, who brought a 3D printer directly to the hospital and, in just a few hours, redesigned and then produced the missing piece…