About healthcare technology
FDA clears new version of Hyperfine’s portable MRI scanner-on-wheels: “Six months after netting the FDA’s green light for its groundbreaking portable MRI machine, Hyperfine Research has secured a second clearance for a newer generation of the device.
The Swoop system brings point-of-care imaging to the patient’s bedside, with a scanner-on-wheels that plugs into a standard electric wall outlet and fits in an elevator.
Designed to scan a person’s head and brain, the latest clearance expands the system’s use to young toddlers, infants and neonates, after it was initially available to patients ages 2 and older.”
About hospitals and health systems
HHS to distribute $1.4 billion to freestanding children's hospitals: “Eligible hospitals will receive 2.5% of their net revenue from patient care” starting this week.
“The money will go to certain free-standing children's hospitals that are not affiliated with larger hospital systems, as financial relief to offset revenue losses.”
About the public’s health
U.S. to make coronavirus strain for possible human challenge trials:”U.S. government scientists have begun efforts to manufacture a strain of the novel coronavirus that could be used in human challenge trials of vaccines, a controversial type of study in which healthy volunteers would be vaccinated and then intentionally infected with the virus…
The work is preliminary and such trials would not replace large-scale, Phase 3 trials such as those now under way in the United States testing experimental COVID-19 vaccines from Moderna Inc and Pfizer Inc, according to a statement emailed to Reuters by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.”
Updated Isolation Guidance Does Not Imply Immunity to COVID-19: From the CDC: “On August 3, 2020, CDC updated its isolation guidance based on the latest science about COVID-19 showing that people can continue to test positive for up to 3 months after diagnosis and not be infectious to others. Contrary to media reporting today, this science does not imply a person is immune to reinfection with SARS-CoV-2, the virus that causes COVID-19, in the 3 months following infection. The latest data simply suggests that retesting someone in the 3 months following initial infection is not necessary unless that person is exhibiting the symptoms of COVID-19 and the symptoms cannot be associated with another illness.People with COVID-19 should be isolated for at least 10 days after symptom onset and until 24 hours after their fever subsides without the use of fever-reducing medications.”
The U.S. has already invested billions in potential coronavirus vaccines. Here’s where the deals stand: “Key Points:
So far, the federal government has struck deals with a handful of pharmaceutical giants that have topped roughly $10.79 billion as part of Operation Warp Speed.
The operation aims to provide at least 300 million doses of a coronavirus vaccine by January 2021.
Moderna, Johnson & Johnson, Pfizer and BioNTech, Sanofi and GlaxoSmithKline, Novavax and AstraZeneca have all received funding from the operation for their vaccines.”
Texas-based McKesson tapped to help get coronavirus vaccines into American communities: ”The U.S. government has chosen medical supplier McKesson to be a centralized distributor for future COVID-19 vaccines, a crucial step in creating a pipeline to get any eventual vaccines into American arms and stop the pandemic…
Several of the current candidate vaccines must be kept at extremely low temperatures — as much as -112 degrees Fahrenheit. That temperature requirement will add to the complexity of distribution.”
FDA creates first-ever medical supply shortage list including masks, swabs and ventilators: ”The Food and Drug Administration (FDA) announced on Friday that it has created its first list of medical supplies that are facing a shortage.” Click on that site and you can ask about:
Personal Protective Equipment
Testing Supplies and Equipment
Ventilation-Related Products
New saliva-based Covid-19 test could be a fast and cheap 'game changer': “Researchers from the Yale School of Public Health created the SalivaDirect test, which received emergency use authorization from the Food and Drug Administration on Saturday…
SalivaDirect test doesn't require a specific swab or collection device. It can also be used with reagents from multiple vendors.
’We simplified the test so that it only costs a couple of dollars for reagents, and we expect that labs will only charge about $10 per sample,’ said Nathan Grubaugh, a Yale assistant professor of epidemiology…
Yale plans to publish its protocol as "open-source," meaning designated labs could follow the protocol to perform their own tests according to Yale's instructions, the FDA said.”
FDA: Don't use rapid COVID tests on people without symptoms:More sensitive PCR tests should be used on these individuals instead.: The headline speaks for itself.
Can Air Conditioners Spread COVID-19?: The quick answer is: “there's a possibility that air conditioning may be a potential route of transmission…” But read the entire article. It is very informative.
Fast Food Intake Among Children and Adolescents in the United States, 2015–2018:
”Key findings:
Data from the National Health and Nutrition Examination Survey
During 2015–2018, over one-third (36.3%) of children and adolescents consumed fast food on a given day.
During 2015–2018, children and adolescents consumed on average 13.8% of their daily calories from fast food on a given day. Adolescents aged 12–19 consumed a higher percentage of calories from fast food than children aged 2–11 years.
Non-Hispanic white adolescents aged 12–19 consumed a lower percentage of calories from fast food on a given day than both non-Hispanic black and Hispanic adolescents.
The percentage of calories from fast food in children and adolescents decreased from 14.1% in 2003–2004 to 10.6% in 2009–2010, and then increased to 14.4% in 2017–2018”
Disparities in Incidence of COVID-19 Among Underrepresented Racial/Ethnic Groups in Counties Identified as Hotspots During June 5–18, 2020 — 22 States, February–June 2020: These disparities continue to be a problem and reports are coming in daily about their extent. This report is from the CDC and concludes: “Long-standing health and social inequities have resulted in increased risk for infection, severe illness, and death from COVID-19 among communities of color…
Among 79 counties identified as hotspots during June 5–18, 2020 that also had sufficient data on race, a disproportionate number of COVID-19 cases among underrepresented racial/ethnic groups occurred in almost all areas during February–June 2020.”
About pharma
Sanofi enters $3.7-billion deal to buy Principia Biopharma: “Sanofi announced Monday a definitive agreement to acquire all of Principia Biopharma's outstanding stock for $100 per share in cash, representing an equity value of around $3.7 billion, boosting the French drugmaker's core research areas of autoimmune and allergic diseases.”
About diagnostics
Anthem and Quest Diagnostics Form Strategic Relationship: “Anthem and Quest will work together to improve efficiency in care delivery and reduce overall costs by leveraging a broad range of tools and programs to drive operational improvements, create pricing transparency, and enhance health care consumer engagement and outcomes. The strategic relationship will focus on consumers in California, Connecticut, Georgia, Indiana, Kentucky, Maine, Missouri, New Hampshire, New York, Ohio, Virginia, and Wisconsin.”