Brigham & Women’s Hospital says it is developing a new, sustainable alternative to N95 respirator masks that are in demand during the COVID-19 pandemic. A team of bioengineers and clinical experts at the Boston-based hospital and the Massachusetts Institute of Technology (MIT) are working on the “injection molded autoclavable, scalable, conformable” iMASC system for providing […]
U.S. paying Novavax $1.6b to ramp up COVID-19 vaccine manufacturing
The U.S. Health and Human Services Dept. and Defense Dept. announced a joint agreement with Novavax (NSDQ:NVAX) worth $1.6 billion to scale the manufacturing of its COVID-19 vaccine candidate. Gaithersburg, Md.-based Novavax’s commercial-scale manufacturing is expected to produce 100 million doses of the investigational vaccine that would become available for use in clinical trials or, should the […]
Mayo Clinic needed to engineer its way through COVID-19: Here’s what they did.
The health system’s medical and engineering staffs had to devise their own solutions for lab gear, PPE and operating room air decontamination. As COVID-19 settles into several regions of the U.S., healthcare systems that once sat on the sidelines likely will find themselves in the same situation as their counterparts in the Northeast did earlier […]
Moderna, Catalent partner on COVID-19 vaccine candidate manufacturing
Moderna (NSDQ:MRNA) and Catalent (NYSE:CTLT) today announced a collaboration for large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate (mRNA-1273) at Catalent’s biologics facility in Bloomington, Ind. Catalent will provide vial filling and packaging capacity, as well as additional staffing required for 24×7 manufacturing operations at the site to support production of an initial 100 million doses […]
COVID-19 lessons learned: 2 manufacturers, a healthcare system and a logistics company share their wisdom
The COVID-19 pandemic put medtech contract manufacturers, OEMs, distributors and healthcare providers in situations for which they were unprepared, particularly with their supply chains. What they learned will undoubtedly help them all going forward, especially if the world faces a second wave or another novel virus. Here are some supply chain lessons learned by a […]
HHS spending $347m to boost supply of COVID-19 vaccine, treatment vials
The U.S. Dept. of Health & Human Services (HHS) and Dept. of Defense (DoD) announced a joint effort to increase manufacturing for vials earmarked for COVID-19-related drugs and vaccines. The Biomedical Advanced Research and Development Authority (BARDA), as part of HHS, collaborated with DoD to provide funding for U.S.-based companies Corning Inc. and SiO2 Materials […]
CAE receives Health Canada nod for CAE Air1 ventilator
CAE (NYSE:CAE) announced today that its CAE Air1 ventilator received certification from Health Canada and is set to treat people with COVID-19. Two months ago, the Canadian government issued a contract to CAE to manufacture and supply 10,000 ventilators amid the COVID-19 pandemic. The devices deliver pressure control, volume control and pressure support ventilation using […]
Sherlock Biosciences announces manufacturing partnership for CRISPR-based COVID-19 test
Sherlock Biosciences announced today that it will collaborate with Integrated DNA Technologies (IDT) to enable large-scale manufacturing of the Sherlock CRISPR SARS-CoV-2 kit for COVID-19 detection. Officials at Cambridge, Mass.–based Sherlock Biosciences think the company’s CRISPR-based diagnostic test, which recently received an FDA emergency use authorization, will increase testing capacity and decreasing time to result […]
FDA restricts re-use of certain respirators for COVID-19
Certain respirators made in China and respirators with exhalation valves should not be decontaminated for re-use by healthcare workers, the FDA announced today. The agency revised these respirators’ emergency use authorizations (EUAs) to reflect the changes. The particular respirators from China “may vary in their design and performance,” the FDA said, basing its decision on […]
FDA warns of cyanide gas danger with improper use of Hologic COVID-19 tests
The FDA warned laboratories today that using certain transport media for COVID-19 samples with Hologic (NSDQ:HOLX) Panther and Panther Fusion diagnostic systems can produce deadly cyanide gas. Transport media is the liquid that maintains a specimen sample while it is transported to a laboratory. The Hologic Panther systems and others that have been sterilized using bleach […]
Battelle under fire for decontamination system performance
Major media outlets are questioning the ability of the Battelle Critical Care Decontamination System (CCDS) to safely reprocess used N95 respirators up to 20 times, as the company has claimed. The FDA granted the nonprofit tech development company an emergency use authorization in March for its vaporized hydrogen peroxide system to decontaminate N95 respirators used […]
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