Canada reportedly signed a contract to purchase 37 million syringes from Becton Dickinson (NYSE:BDX) in preparation for a potential COVID-19 vaccine. A report in The Record revealed that Public Services & Procurement Minister Anita Anand said the country made a purchase order from the Canadian branch of BD in an effort to make sure Canada is […]
Contract Manufacturing
Steris wins second EUA to decontaminate up to 30m respirators per day
Steris (NYSE:STE) has won an FDA emergency use authorization (EUA) for a new steam sterilization method to decontaminate used N95 respirators. The EUA covers the new Steris Steam Decon cycle to decontaminate 3M 1860, 3M 1860S, and 3M 1804 NIOSH-approved N95 respirators that are or might be contaminated with SARS-CoV-2 and other pathogenic microorganisms. The FDA […]
Ga. warehouse workers sue Sterigenics, ConMed over EtO exposure
Fifty-three people who worked in an Atlanta-area warehouse that stored medical devices sterilized by ethylene oxide (EtO) filed suit this week against Sterigenics and its parent company over exposure to the gas. The plaintiffs or their families claim that long-term EtO exposure to the sterilized devices, which they unloaded, handled, warehoused and distributed, caused multiple deaths, cancer, […]
FDA eases regs on certain device changes during pandemic
The FDA will allow limited changes to certain devices so medtech companies can address manufacturing and supply chain issues due to COVID-19-related disruptions. In a guidance released yesterday, the agency said it would allow changes to devices approved through its premarket approval (PMA) and humanitarian device exemption (HDE) pathways as long as those changes do not create […]
This patient-mover got an emergency COVID-19 nod from the FDA
AR Tech, a division of A&R Tarpaulins, announced today that the FDA has granted an EUA for its Patient Isolation Transportation Unit (PITU) to help hospitals better manage the COVID-19 pandemic. “PITU is a game-changer in this fight against the pandemic because it is a negative pressure isolation enclosure that makes working with highly contagious […]
Phlow lands $354m government contract for COVID-19 medications
Phlow announced today that it received $354 million in U.S. government funding to manufacture essential medicines at risk of shortage, including those involved in the COVID-19 pandemic response. Richmond, Va.-based Phlow’s manufacturing is being funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of Assistant Secretary for Preparedness and Response (ASPR) […]
Beckman Coulter awarded expanded contract for sepsis algorithm
Beckman Coulter announced that it received an expanded partnership with BARDA for its expanding COVID-19 medical countermeasure portfolio. BARDA (the Biomedical Advanced Research and Development Authority, part of the U.S. Dept. of Health and Human Services) awarded Beckman Coulter the partnership in collaboration with Dascena, Inc. The collaboration will offer advanced research and development toward […]
RespiraWorks, ICS partner on inexpensive ventilator for developing countries
RespiraWorks. and Integrated Computer Solutions (ICS) announced a partnership to collaborate on the former’s open-source ventilator. San Francisco-based Respiraworks touts the medical-grade device as capable of being assembled for less than $500. The company designed the system for long-term vs. crisis use and for developing countries with the intent to source and manufacture locally, according […]
Integer beats The Street on Q1 results, expects temporary COVID-19 sales hit
Integer Holdings (NYSE:ITGR) shares are up slightly today after the company posted Street-beating first-quarter results the previous evening. The Plano, Texas–based medical device contract manufacturing giant reported profits of $31 million, or 29¢ per share, off sales of $328 million for the quarter ended April 3, 2020, for a bottom-line gain of 46% off 4% sales […]
3M wins federal contracts to further expand U.S. respirator production
3M (NYSE:MMM) announced today that it received two more U.S. Department of Defense contracts to further expand its domestic production of N95 respirator masks. Since January, the Maplewood, Minn.-based company has doubled its global output of respirators to 1.1 billion per year, with 35 million N95 masks produced per month in the U.S. According to a […]
Cleanbox launches UV-C mask decontamination device
Cleanbox Technology announced that it is launching its CleanDefense ultraviolet point-of-use mask decontamination product in response to the COVID-19 pandemic. The Carlsbad, Calif.-based company’s technology uses UV-C light in an LED to decontaminate products worn on the face or the head with a focus on high-risk contagion transfer points. According to a news release, Cleanbox […]