coronavirus Archives - Page 73 of 99 - Medical Design Sourcing

HHS to release 1.5M N95 respirators to nursing homes

HHS will release 1.5 million N95 respirators from the Strategic National Stockpile for distribution to approximately 3,336 nursing home facilities across the United States.

The respirators, made in the U.S. by the Halyard business of Owens & Minor (NYSE:OMI), will go to select nursing homes that recently reported only enough supplies for only zero to three days of operations, according to the announcement, posted yesterday. Shipments start Aug. 28.

“President Trump and Secretary Azar remain fully committed to caring for our nation’s most vulnerable citizens, and that means ensuring nursing homes have the equipment and supplies they need to treat patients safely during the pandemic,” said Dr. Robert Kadlec, the HHS Assistant Secretary who oversees the SNS. “This additional federal supplement of N95 respirators from the SNS will immediately help those nursing homes prevent the spread of COVID-19 and keep the patients they care for safe during this pandemic.”

Hahn apologizes for convalescent plasma claim

FDA commissioner Stephen Hahn

Under intense criticism for his statement that convalescent plasma donated by former coronavirus patients could reduce COVID-19 deaths by 35%, FDA commissioner Stephen Hahn apologized on Twitter late Monday.

The agency announced on Sunday that it had granted an emergency use authorization (EUA) for plasma donated by coronavirus survivors as a treatment for new patients. President Trump, Hahn and U.S. Health and Human Services secretary Alex Azar all touted the 35% figure based on a small subgroup of hospitalized COVID-19 participants in a Mayo Clinic study — patients who were younger than 80 years old, not on ventilators and who received plasma that contained high levels of antibodies within 3 days of diagnosis, according to a report by the New York Times.

Get the full story on our sister site, Medical Design & Outsourcing.

Report: 20,000 COVID cases traced to Boston medtech company’s conference

The “super-spreading” event held by Biogen (NSDQ:BIIB) in February reportedly led to approximately 20,000 COVID-19 cases across four Massachusetts counties.

According to a Boston Globe report, the international company meeting at the Marriott Long Wharf hotel in Boston was said to have resulted in 99 identified cases of the virus, but, according to scientists studying early cases, that number reached roughly 20,000 by early May in those four counties.

Researchers studied all confirmed early cases of COVID-19 in the area by changes in the genetic makeup of coronaviruses to gauge the spread of the event hosted by Cambridge, Mass.-based Biogen, according to The Globe.

Almost all of the 772 cases observed came from Essex, Middlesex, Norfolk and Suffolk counties. Through observing mutations in the genetic code of the viruses, the researchers identified more than 80 distinct SARS-CoV-2 genomes that spread around the Boston area, the report says. Read more

Dräger boosts N95 mask production with new U.S. facility opening

Image from Draeger

Dräger announced today that it is opening a new production facility in Pennsylvania to manufacture N95 respirator masks.

Telford, Pa.-based Dräger’s new production facility is located in Montgomeryville, Pa., and is set to begin production in September 2020 with 50 highly skilled jobs slated to be added to the local community.

Get the full story at our sister site, Medical Design & Outsourcing.

Dräger boosts N95 mask production with new U.S. facility opening

Image from Draeger

Dräger announced today that it is opening a new production facility in Pennsylvania to manufacture N95 respirator masks.

Telford, Pa.-based Dräger’s new production facility is located in Montgomeryville, Pa., and is set to begin production in September 2020 with 50 highly skilled jobs slated to be added to the local community.

Get the full story at our sister site, Medical Design & Outsourcing.

Dräger boosts N95 mask production with new U.S. facility opening

Image from Draeger

Dräger announced today that it is opening a new production facility in Pennsylvania to manufacture N95 respirator masks.

Telford, Pa.-based Dräger’s new production facility is located in Montgomeryville, Pa., and is set to begin production in September 2020 with 50 highly skilled jobs slated to be added to the local community.

The facility will operate 24/7 to produce N95 masks for its contract from the U.S. Dept. of Health and Human Services as more masks are needed in the fight against COVID-19.

“Respiratory protection technology has been at the heart of Dräger’s Technology for Life mission since our company’s inception in 1889,”Dräger North America president & CEO Lothar Thielen said in a news release. “In recent years, the demand for personal protective equipment has been substantial, and the emergence of COVID-19 greatly escalated the demand for quality safety…

Dräger boosts N95 mask production with new U.S. facility opening

Image from Draeger

Dräger announced today that it is opening a new production facility in Pennsylvania to manufacture N95 respirator masks.

Telford, Pa.-based Dräger’s new production facility is located in Montgomeryville, Pa., and is set to begin production in September 2020 with 50 highly skilled jobs slated to be added to the local community.

The facility will operate 24/7 to produce N95 masks for its contract from the U.S. Dept. of Health and Human Services as more masks are needed in the fight against COVID-19.

“Respiratory protection technology has been at the heart of Dräger’s Technology for Life mission since our company’s inception in 1889,”Dräger North America president & CEO Lothar Thielen said in a news release. “In recent years, the demand for personal protective equipment has been substantial, and the emergence of COVID-19 greatly escalated the demand for quality safety…

Feds’ convalescent plasma claim questioned

[Coronavirus image courtesy of World Health Organization]

Scientists are questioning the Trump administration’s claim for the effectiveness of convalescent plasma in preventing deaths from COVID-19, according to published reports.

President Trump and the heads of the FDA and the Department of Health and Human Services all said on Sunday that plasma donated by former coronavirus patients has reduced deaths by 35%. Their calculation appears to be based on a small subgroup of hospitalized COVID-19 participants in a Mayo Clinic study — patients who were younger than 80 years old, not on ventilators and who received plasma that contained high levels of antibodies within 3 days of diagnosis, according to a report by the New York Times.

Get the full story on our sister site, Medical Design & Outsourcing.

Medtronic’s recovery ‘faster than expected’ during its Q1

Medtronic (NYSE:MDT) shares ticked up today on first-quarter results that came in ahead of the consensus forecast.

The Fridley, Minn.-based company posted profits of $491 million, or 36¢ per share, on sales of $6.5 billion for the three months ended July 31, 2020, for a -44% bottom-line slide on a sales decline of -13.2%.

Adjusted to exclude one-time items, earnings per share were 62¢, 44¢ ahead of Wall Street, where analysts were looking for sales of $5.4 billion.

As a result of the COVID-19 pandemic and subsequent delays in elective procedures, Medtronic saw a -14% sales decrease in its minimally invasive therapies segment, a -13% sales drop in its cardiac and vascular group, a -15% dip in restorative therapies and a 5% skid in diabetes.

“We reported solid improvement from last quarter, and our results reflect a faster than expected recovery from the depths of the pandemic we saw back in April,” Medtronic CEO Geoff Martha said in a news release.…

Report: Top FDA official vows to quit if vaccine approved prematurely

A top FDA official has threatened to resign if the Trump administration moves too quickly to approve a vaccine for COVID-19, according to a published report.

Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER), made the threat over concerns a vaccine would be approved without being proven safe and effective, according to a report by Reuters. The news agency quoted Marks as saying that he is not under political pressure to speed a vaccine to market but that he would quit if that changed.

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

Report: Top FDA official vows to quit if vaccine approved prematurely

A top FDA official has threatened to resign if the Trump administration moves too quickly to approve a vaccine for COVID-19, according to a published report.

Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER), made the threat over concerns a vaccine would be approved without being proven safe and effective, according to a report by Reuters. The news agency quoted Marks as saying that he is not under political pressure to speed a vaccine to market but that he would quit if that changed.

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

Report: Top FDA official vows to quit if vaccine approved prematurely

A top FDA official has threatened to resign if the Trump administration moves too quickly to approve a vaccine for COVID-19, according to a published report.

Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER), made the threat over concerns a vaccine would be approved without being proven safe and effective, according to a report by Reuters. The news agency quoted Marks as saying that he is not under political pressure to speed a vaccine to market but that he would quit if that changed.

“I could not stand by and see something that was unsafe or ineffective that was being put through,” Marks told Reuters. “You have to decide where your red line is, and that’s my red line. I would feel obligated (to resign) because in doing so, I would indicate to the American public that there’s something wrong.”

Public health officials have expressed concern that the administration might move too quickly on a COVID-19 vaccine a…