The FDA granted an emergency use authorization to Qiagen (NYSE:QGEN) for a diagnostic test that the company said can differentiate among COVID-19 and 20 other respiratory diseases that cause similar symptoms, the company said today. The SARS-CoV-2 Panel test works in about an hour, according to Netherlands-based Qiagen. It is a multiplexed nucleic acid test […]
4 medtech companies ink $84m government ventilator contract
The U.S. Defense Logistics Agency (DLA) signed an $84.4 million contract over the weekend with four medtech companies to produce 8,000 ventilators to fight the COVID-19 pandemic. The contract is with Combat Medical Systems, Hamilton Medical, Vyaire Medical and Zoll Medical, according to the agency. Shipments may begin in a few days with time-phased delivery […]
Medline reopens Illinois medtech sterilization plant
Medline Industries resumed sterilization operations at its Waukegan, Ill., plant on Friday, following state certification of the company’s $10 million in emission-control upgrades, the company announced. The Waukegan plant reopening follows the decision this week by officials in Cobb County, Ga., to allow an Atlanta Sterigenics EtO plant to reopen for 21 days to sterilize devices and products […]
AdvaMed: Invoking Defense Production Act could hinder U.S. medtech imports
Forcing manufacturers to repurpose their production lines to make equipment to fight the coronavirus epidemic might actually hurt the U.S. supply of those items, the head of medtech trade group AdvaMed said today. AdvaMed officials have talked with U.S. secretary of Health and Human Services Alex Azar and FDA commissioner Dr. Stephen Hahn about medtech […]
Judge tosses wrongful termination suit against Abiomed
Abiomed (NSDQ:ABMD) has convinced a federal judge that whistleblower Max Bennett had no basis on which to claim the company fired him in retaliation for his investigation of federal False Claims Act violations. Judge Indira Talwani ruled on Tuesday that “no reasonable jury could find that Bennett had engaged in protected activity or that he was […]
European Commission scrutinizes J&J TachoSil buy
The European Commission said Wednesday that it has opened an in-depth investigation of the proposed $400 million acquisition of Takeda Pharmaceutical’s (TSE:4502;NYSE:TAK) TachoSil surgical sealant patch by Johnson & Johnson (NYSE:JNJ). The commission said it is concerned that the acquisition by J&J’s Ethicon unit may reduce competition and innovation for the supply of dual haemostatic patches, used […]
FDA warns against at-home COVID-19 tests
The FDA is warning consumers against unauthorized COVID-19 test kits marketed for use in the home. The agency said it has not authorized any diagnostic test for the virus for at-home use, nor has it endorsed any prevention or treatment claims that individual companies have made. The FDA also said it is not naming any […]
Factory CRO Group rebrands as Avania
Medtech contract research organization Factory-CRO Group is changing its name to Avania. Formed Boston-based Boston Biomedical Associates (Marlborough, Mass.), Factory CRO (Bilthoven, Netherlands), Five Corners (Artarmon, Australia), and MileStone Research Organization (San Diego), Avania said it will bring together regional teams of experts across a wide range of therapeutic specialties, including medical devices, novel technology, […]
FDA to authorize certain imported respirators for healthcare worker use
The FDA said yesterday that certain imported respirators (FFRs) may be eligible for emergency use authorization (EUA) to protect public health and safety during the coronavirus outbreak. The FDA said these these devices, imported from Australia, Brazil, Europe, Japan, Korea and Mexico, may be effective in protecting healthcare workers from airborne COVID-19 particulates, “based on […]
Pressure mounts to reopen Sterigenics Ga. plant to address coronavirus pandemic
Under pressure from the FDA, officials in Cobb County, Ga., may allow Sterigenics to reopen a medical device sterilization plant sooner than expected to address the coronavirus pandemic. Oak Park, Ill.-based Sterigenics temporarily shut the Atlanta plant on August 26 to voluntarily upgrade emission controls for ethylene oxide (EtO), the carcinogenic gas it used to […]
How medtech contract manufacturers are managing during the coronavirus pandemic
From invoking their business continuity plans to marshaling their pandemic teams, medical device contract manufacturers are finding ways to keep business going during the coronavirus pandemic. Medical Design & Outsourcing conducted an informal survey of manufacturers and other companies that serve the medtech industry. Here’s some of what we learned. Get the full story on our […]