The FDA has granted emergency use authorization to Synapse Biomedical (Oberlin, Ohio) for its TransAeris diaphragmatic pacing stimulator to help wean COVID-19 patients off of ventilators. TransAeris is the first system authorized by the FDA to perform such a task. The 30-day authorization is aimed at patients considered at high risk of weaning failure. It […]
Respiratory
3M sues Florida company for alleged mask price-gouging
3M (NYSE:MMM) has sued a Florida company for allegedly trying to sell tens of millions of the company’s N95 respirators to the federal government at inflated prices. The lawsuit filed in the U.S. District Court for the Northern District of Florida alleges that Orlando-based Geftico LLC twice attempted to fraudulently sell the “likely nonexistent” respirators at […]
Coala Heart Monitor receives EUA to provide remote heart and lung exams
Coala Life announced today that it received FDA emergency use authorization (EUA) for an expanded indication for its Coala Heart Monitor. The expanded indication for the heart monitor enables physicians to remotely monitor heart and lung sounds in real-time, which can be used in COVID-19 respiratory diagnostic exams. Coala, a Swedish company with a location […]
General Motors kicks off mass production of ventilators
General Motors today began mass production of the Ventec Life Systems V+Pro critical care ventilator at the automaker’s Kokomo, Ind. plant. GM and Ventec have a $489.4 million contract from the U.S. Department of Health and Human Services to deliver 6,132 ventilators to the Strategic National Stockpile by the end of June, with 30,000 shipped […]
Inspire soars on Q1 sales projection
Inspire Medical Systems (NYSE:INSP) shares shot up more than 8% today on a first-quarter revenue projection of approximately $21.3 million, up 31% from the $16.3 million it pulled in during the first quarter of 2019. Shares of INSP were up 8.2% at $68.61 per share in mid-afternoon trading today. Inspire also withdrew its full-year guidance today […]
B. Braun lands FDA EUA for use of infusion pumps with nebulizers to treat COVID-19
B. Braun Medical announced that it received FDA emergency use authorization to use its infusion pumps with nebulizers to treat patients with COVID-19. The Bethlehem, Pa.-based company’s authorization win includes its Perfusor space syringe infusion pump, Infusomat space volumetric infusion pump and Outlook ES pump systems. Health providers can use the pumps for tracheal delivery […]
3M, Cummins partner on respirator filters
3M (NYSE:MMM) announced today it is working with diesel engine manufacturer Cummins to more than double production of high-efficiency particulate filters for use in 3M’s powered air purifying respirators, or PAPRs. 3M said it needs the filters for the additional PAPRs it is manufacturing to meet a surge in demand for personal protective equipment due to […]
Philips ups plans for ventilator production, debuts new ventilator
Royal Philips (NYSE:PHG) announced today that it plans to double production of its hospital ventilators by next month with an eye on a four-fold increase by the third quarter of 2020. The Amsterdam-based company is building on its initial doubling of production amid a shortage of equipment for the COVID-19 pandemic. On top of that, the […]
Hamilton Medical, Vyaire lead the way among 7 new ventilator contracts from HHS
Hamilton Medical, Vyaire and Zoll Medical by far had the largest ventilator contracts among seven new deals that the U.S. Department of Health and Human Services has announced. The contracts, announced yesterday evening and worth a total of $1.44 billion, come on top of previously announced deals with Royal Philips (NYSE:PHG), which is receiving $646.7 million, […]
Hamilton Medical opening Nevada factory to produce ventilators under $551.6m deal
The Switzerland-based ventilator maker Hamilton Medical is opening a factory in Reno, Nev. so that it can meet a five-month, $551.6 million contract with the U.S. Department of Health and Human Services, according to Rep. Mark Amodei, R-NV. “Nobody should be saying mission accomplished while we’re still living in the midst of this challenge. However, […]
Ford to start production of new powered air-purifying respirator to fight coronavirus
Ford Motor Co. said production will start tomorrow on a new powered air-purifying respirator created with design and testing consultation from 3M (NYSE:MMM). Roughly 90 paid United Auto Workers volunteers will assemble respirators at Ford’s Vreeland facility near Flat Rock, Mich. The operation will have the ability to churn out more than 100,000 of the respirators, […]