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What is a medical ventilator and how does it work?

Image from Ventec Life Systems

The ventilator has come to the fore as a vital piece of equipment during the COVID-19 pandemic.

Put simply, ventilators exist to help patients who can’t breathe, breathe. The novel coronavirus’ attack on the respiratory system brought ventilators into the spotlight, forcing the U.S. to turn to its strategic national stockpile as manufacturers scrambled to scale-up production in short order.

While some of the major manufacturers pump out machines and fulfill recently awarded government contracts, researchers at universities and laboratories have entered the ring with alternative ventilators falling under FDA emergency use authorization (EUA) guidelines. However, while useful in a time of need, the alternative machines that cover mechanical ventilation struggle to scratch the surface of capabilities attributable to the in-demand ICU ventilators.

Univers…

Beckman Coulter COVID-19 antibody test receives FDA EUA

Beckman Coulter announced today that it received FDA emergency use authorization (EUA) for its Access SARS-CoV-2 IgG assay.

Brea, Calif.-based Beckman Coulter has already shipped its COVID-19 antibody assay to more than 400 hospitals, clinics and diagnostics laboratories in the U.S. and began distribution globally to countries that accept EUA and its recently garnered CE Mark, according to a news release.

Beckman Coulter said it is capable f delivering more than 30 million tests a month, having already received independent validation for its test from the Henry Ford Health System, along with regulatory authorization.

“We selected the Beckman Coulter Access SARS-CoV-2 IgG antibody assay to be the backbone of Henry Ford’s COVID-19 serology testing program because of its outstanding performance in our rigorous independent evaluation,” Henry Ford Health division head of chemistry-pathology Dr. Bernard Cook said in the release. “Henry…

Federal officials to young people: Stop spreading COVID-19

As the numbers of positive COVID-19 cases soars across the South, federal officials today implored young people to be more careful about spreading the disease.

Members of the White House Coronavirus Task Force, holding their first public briefing in two months, spoke of the risks of continuing to spread the virus by people who are the least at risk for serious complications and death to those who are.

Although Drs. Deborah Birx and Anthony Fauci said they weren’t blaming anyone for spreading the virus, they clearly singled out millennials, who have begun returning to bars and other social venues in states that have opened their economies. Fauci also noted that the greatest increase in cases is coming in people under 40.

“Anyone who gets infected or is at risk of getting infected, to a greater or lesser degree, is part of the dynamic process of the outbreak,” he said. “A risk for you is not just isolated to you. Because if you are infected, you are in dan…

Partnership will study use of existing drugs for COVID-19 and and more

A new collaboration funded by in part by $1.1 million from the FDA is working on finding new uses for existing drugs for areas of high unmet medical need — with a pilot project focused on treatments for COVID-19.

The Critical Path Institute (C-Path) this week announced the launch of the CURE Drug Repurposing Collaboratory (CDRC). The National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH), is also supporting the public-private partnership, which aims to create a network connecting major treatment centers, academic institutions and researchers, private practitioners, government facilities and health care professionals around the world.

Get the full story on our sister site, Drug Discovery & Development.

Partnership will study use of existing drugs for COVID-19 and and more

A new collaboration funded by in part by $1.1 million from the FDA is working on finding new uses for existing drugs for areas of high unmet medical need — with a pilot project focused on treatments for COVID-19.

The Critical Path Institute (C-Path) this week announced the launch of the CURE Drug Repurposing Collaboratory (CDRC). The National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH), is also supporting the public-private partnership, which aims to create a network connecting major treatment centers, academic institutions and researchers, private practitioners, government facilities and health care professionals around the world.

CDRC will focus on capturing relevant real-world clinical outcome data through the FDA-NCATS CURE ID web platform and mobile app. CURE ID is designed to serve as a centralized source of reliable, curated, clinician-submitted information.

“The CURE ID platform enabl…

Texas governor halts elective procedures in populous counties

Texas Medical Center in Houston is among the hospitals ordered to halt elective procedures to slow the spread of COVID-19. (Image from Visit Houston Texas)

Citing the need to preserve hospital beds for COVID-19 patients, Texas Gov. Greg Abbott today issued an executive order halting elective medical procedures in the state’s four most heavily populated counties .

The order, issued this morning, covers the counties of Bexar, Dallas, Harris and Travis counties. Bexar County includes the city of San Antonio. Houston is in Harris County and Travis County includes Austin.

COVID-19 cases hit a new high over the past 13 days, according to a report by an KXAS in Fort Worth. The number of coronavirus patients in Texas hospitals reached 4,389 on Wednesday, up from 1,784 on June 1, the television station reported. Abbott also halted the reopening of the Texas economy.

“As Texas faces a rise in COVID…

Report: Trump fundraiser tried to cash in on N95 masks

N95 respirator [Image from the FDA]

The co-founder of a political action committee that has raised funds for President Donald Trump may have attempted to profit from N95 respirators made by 3M (NYSE:MMM), according to a report by CBS News.

The report said that, shortly after Trump invoked the Defense Production Act to obtain 3M’s respirators, Great America PAC (which raised more than $40 million in support of Trump) co-founder Eric Beach formed Colt International, touting connections with 3M despite having no known experience in supplying medical goods.

CBS News cited a letter sent to prospective customers and signed by Beach that claimed Colt International would work directly with 3M and its distributors and offering Beach’s contact information. Another letter claimed that Colt’s ties to 3M would provide local governments, hospitals and first responders access to a stock of “sever…

DOD launches $100m initiative to return COVID-19-related medtech, pharma manufacturing to the U.S.

The U.S. Department of Defense announced today that it will dedicate $100 million authorized by the CARES Act to boost medtech and pharmaceutical manufacturing in the U.S.

Working with DOD, the U.S. International Development Finance Corporation (DFC) launched a request for proposals from companies seeking financing under the Defense Production Act, which prioritizes government orders amid a war or national crisis.

Get the full story on our sister site MassDevice.

Henry Schein execs extend pay cuts

Henry Schein (NSDQ:HSIC) announced that it is continuing certain cost reduction measures, including payroll cuts, amid the COVID-19 pandemic.

The Melville, N.Y.-based medical device maker said in a news release that chairman and CEO Stanley Bergman agreed to extend his prior agreement to a temporary reduction of 100% of his base salary from April 6, 2020, through the end of the company’s fourth fiscal quarter.

Bergman also agreed that the extension of his salary reduction will not constitute “good reason” or breach under his employment agreement and will not confer or trigger additional rights or entitlements from him or the company or its affiliates.

Four of Henry Schein’s highest-paid executive officers serving as of Dec. 28, 2019, including its CFO, will continue temporary salary reductions at a level of 37.5% from June 29, 2020, the first business day of its third fiscal quarter, until a later date. Previously, they had taken …

Report: FDA lists 106 adverse events for Abbott’s rapid COVID-19 test; none for other rapid tests

Abbott’s ID Now test machine (Image from Abbott)

Users of the Abbott (NYSE:ABT) ID Now point-of-care diagnostic test for COVID-19 have reported 106 false-negative or otherwise incorrect or inadequate results to the FDA since April — and none for other companies’ rapid diagnostics for the novel coronavirus, according to a report by Kaiser Health News.

That’s up from the 15 adverse event reports the agency reported it had received by May 14, when it issued a warning about the test’s accuracy. The FDA granted the ID Now test an emergency use authorization (EUA) on March 27, and by mid-May said it was investigating whether the false-negative results could be due to the types of swabs used or the type of viral transport media. A preliminary study released in May by researchers at New York University found that the test missed up to 48% of positive results. Researchers at the Cleveland Cli…

Most Americans concerned about rising drugs costs amid COVID-19, Gallup says

[Image from Unsplash]

A new study by West Health and Gallup revealed that Americans are concerned with potential negative developments resulting from the COVID-19 pandemic.

Nearly 90% of the 1,016 U.S. adults surveyed between May 11, 2020, and May 22, 2020, said they are “very” (55%) or “somewhat” (33%) concerned that the pharmaceutical industry will leverage the ongoing pandemic to raise drug prices. According to a news release, Democrats (66%) were more likely to say they are concerned than independents (52%) and Republicans (49%).

Get the full story at our sister site, Pharmaceutical Processing World.

Most Americans concerned about rising drugs costs amid COVID-19, Gallup says

[Photo by Fusion Medical Animation on Unsplash]

A new study by West Health and Gallup revealed that Americans are concerned with potential negative developments resulting from the COVID-19 pandemic.

Nearly 90% of the 1,016 U.S. adults surveyed between May 11, 2020, and May 22, 2020, said they are “very” (55%) or “somewhat” (33%) concerned that the pharmaceutical industry will leverage the ongoing pandemic to raise drug prices. According to a news release, Democrats (66%) were more likely to say they are concerned than independents (52%) and Republicans (49%).

Other concerns raised include, to a lesser extent, rising health insurance premiums and the general cost of care, with 79% of those surveyed saying they are very or somewhat concerned about their premiums. Additionally, 84% said they are very or somewhat concerned about the cost of care generally rising and 41% are very con…