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 […]
Distribution
Nanox inks $48m distro deal for Russia and Belarus
Nanox Imaging announced today that it entered into exclusive distribution agreements for its medical imaging services in Russia and Belarus. Under the agreement, unnamed distribution partners will commit an annual service fee to Nanox of approximately $48 million over three years, subject to regulatory approval and acceptance test clearance. The commitment is backed by a […]
Chinese company faces federal charges in ‘fake’ N95 respirator case
A Chinese manufacturer has been charged with producing and exporting to the United States nearly half a million misbranded and defective masks that falsely purported to be N95 respirators, the federal government reported. King Year Packaging and Printing Co. Ltd. (King Year) faces three counts of violating the Federal Food, Drug and Cosmetic Act (FDCA) […]
U.S. senators demand investigation of Trump COVID-19 supply chain effort
Three U.S. senators today demanded an investigation into Project Air Bridge, a Trump administration supply chain management project to import personal protective equipment (PPE) and other medical supplies during the COVID-19 pandemic. Dubbing the project “opaque,” U.S. Senators Elizabeth Warren (D-Mass.), Chuck Schumer (D-N.Y.) and Richard Blumenthal (D-Conn.) also released new documents and information from […]
U of M releases Coventor ventilator design as open-source
The University of Minnesota recently announced that it released the design for its Coventor alternative ventilator as open-source. Minnesota’s Coventor low-cost device gained notoriety in March after researchers touted the design made from various parts totaling just $150. In April, it became the first ventilator of its kind authorized for use under the FDA’s EUA […]
Fibralign partners with Terumo
Stanford spin-out Fibralign announced today that it entered into a long-term distributor agreement with Terumo for the BioBridge collagen matrix. The agreement is set to see Terumo market and distribute BioBridge collagen matrix, which is used to treat and prevent secondary lymphedema, in Japan. BioBridge is a sterile, implantable, biocompatible and biodegradable surgical mesh made […]
FDA signals PPE shortage, issues EUA for more
The FDA has issued a call for manufacturers to produce more non-surgical gowns and other personal protective equipment (PPE) as the coronavirus pandemic makes its way across the country. The emergency use authorization issued Friday also listed conductive shoes and shoe covers, operating room shoes and shoe covers, surgical helmets and caps and other surgical […]
Study: PPE shortages persist nationwide
Shortages of personal protective equipment continue to plague hospitals and healthcare facilities across the United States, according to a study published this week in The Lancet. The study reports on data collected by GetUsPPE, a volunteer organization connecting healthcare providers with supplies of PPE during the COVID-19 pandemic and was authored by academics and volunteers […]
Gilead licenses remdesivir production to 5 generic drugmakers
Gilead Sciences’ (NSDQ:GILD) said Tuesday that it has signed licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of remdesivir, the experimental drug being used in the U.S. to treat COVID-19. The non-exclusive, voluntary agreements allow the companies — Mylan (NSDQ:MYL), Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences — […]
3M, Ford to begin shipping respirators to COVID-19 first responders
3M (NYSE:MMM) and Ford Motor Company announced today that they have begun shipping 10,000 of the jointly developed powered air-purifying respirators (PAPRs) to healthcare workers fighting COVID-19. Production began April 13 at Ford’s Vreeland facility near Flat Rock, Mich., after 40 days of development, according to 3M. 3M said it will sell and distribute the PAPRs […]
AdvaMed’s Whitaker calls for pandemic cooperation
Preparation for future pandemics will require closer cooperation between the medtech industry and the U.S. government, according to Scott Whitaker, CEO and president of the trade group AdvaMed. In an interview on the DeviceTalks Weekly podcast, Whitaker laid out steps he believes the federal government and medtech industry must take, including addressing medical device and […]