The FDA today issued emergency use authorization (EUA) for a low-cost ventilator developed by the University of Minnesota and produced by Boston Scientific (NYSE:BSX). Minnesota’s Coventor device made waves last month after researchers touted the design made from various parts totaling just $150. It’s now the first ventilator of its kind authorized for use under the […]
COVID-19
Unique Software Development launches 3D printing initiative to beat coronavirus
Unique Software Development announced today that it launched the “MakerCause” initiative to centralize 3D printing efforts for necessary equipment in the fight against COVID-19. MakerCause sets out to offer a way to produce 3D printed respirator masks, face shields and nasopharyngeal swabs to support healthcare workers, first responders and those with suppressed immune systems amid […]
Synapse Biomedical wins emergency nod for ventilator-weaning device
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 […]
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 […]
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 […]
BD wins EUA, CE Mark for COVID-19 test that can return results in hours
Becton Dickinson (NYSE:BDX) announced today that it received FDA emergency use authorization (EUA) and CE Mark approval for a new COVID-19 molecular diagnostic test. The test, based on the U.S. Centers for Disease Control assay design and run on the BD Max system, may return results in 2-3 hours, according to the Franklin Lakes, N.J.-based company. […]
J&J beats The Street but lowers outlook for 2020
Johnson & Johnson (NYSE:JNJ) beat analysts’ expectations for sales and earnings in the first quarter of 2020, but lowered its financial outlook for the year due to the coronavirus pandemic. The New Brunswick, N.J.-based company reported profits of $6.154 billion, or $2.30 per share, on sales of $20.69 billion for the three months ended March 29, 2020, […]
FDA approves first saliva-based coronavirus test
The FDA granted emergency use authorization (EUA) to Rutgers University’s RUCDR Infinite Biologics and its collaborators for an approach using saliva as test biomaterial for COVID-19. In tandem with Spectrum Solutions and Accurate Diagnostics Labs, RUCDR developed the saliva collection methods as an alternative to nose and throat swabs when testing for SARS-CoV-2, the virus […]