The FDA is urging healthcare providers to use ventilator splitters for COVID-19 patients only when there is no alternative. The agency released a letter to providers asking them to consider non-invasive ventilation such as high-flow nasal oxygen or non-invasive positive pressure ventilation before resorting to a ventilator splitter. If a ventilator splitter is the only option, the […]
Hospital Care
Medtronic touts newborns study involving its Nellcor pulse oximetry tech
Medtronic (NYSE:MDT) announced today that study results showed superiority for its Nellcor pulse oximeter against technology from Masimo (NSDQ:MASI). Fridley, Minn.-based Medtronic’s Nellcor bedside SpO2 patient monitoring system was compared with the Masimo Radical-7 pulse co-oximeter with both set at the highest sensitivity for electrocardiography (ECG) monitoring following the delivery of 60 term newborns by Caesarian section, according […]
Feds to order 61M more at-home coronavirus tests, build surgical glove factories
Just days after ordering 8.5 million at-home tests from Ellume, the Biden administration announced today that it’s in talks with six other at-home coronavirus test manufacturers. In an online briefing, Tim Manning, the national supply chain coordinator for COVID response, told reporters that these companies could produce another 61 million at-home tests by the end of […]
FDA grants EUA for CPAP filter to make devices safer around healthcare workers
Azimuth Sleep Solutions announced today that it received FDA emergency use authorization (EUA) for its PortPatch product. PortPatch, a patent-pending product, is designed to expand air filtration capabilities for patient treatment options and to keep healthcare workers safer in patient care areas in which non-invasive ventilatory treatment devices are in use. Memphis, Tenn.-based Azimuth Sleep […]
House committee investigates $70M federal contract for AutoMedx ventilators
A Congressional committee has launched an investigation into a $70 million White House contract for ventilators that reportedly are inadequate to treat people with COVID-19. The Department of Defense signed a $16.2 million contract in spring 2020 to buy SAVe II ventilators, manufactured by AutoMedx (Addison, Tex.), from the supplier Combat Medical Systems, according to the House Committee […]
FDA says to limit mask decontamination to 4 cycles
Soon after healthcare workers began warning of personal protective equipment (PPE) shortages, companies and other organizations started claiming their decontamination systems could reprocess used filtering facepiece respirators (FFRs) such as N95s up to 20 times. The FDA began issuing emergency use authorizations (EUAs) for FFR decontamination systems with a range of allowable cycles and major media […]
FDA adds to pandemic-related shortage list
The FDA today announced new shortages of laboratory testing supplies needed for the COVID-19 pandemic and renewed its shortage listing for several types of personal protective equipment (PPE). Newly categorized as being in short supply are micro-pipettes and what the agency described as general-purpose lab equipment. Read the full list on our sister site, Medical […]
Spark Biomedical wins FDA breakthrough nod for newborn opioid withdrawal relief device
Spark Biomedical announced today that the FDA granted breakthrough device designation to its transcutaneous electrical nerve stimulator designed to reduce signs and symptoms of neonatal opioid withdrawal syndrome (NOWS). NOWS results from exposure to prescription or non-prescription opioids such as methadone or heroin during pregnancy. Currently, no nationwide standard of care exists for managing NOWS, although […]
PPE makers want revamp of pandemic planning and supply distribution
Personal protective equipment manufacturers are asking the federal government to beef up its planning for and management of future pandemics to avoid the shortages that have endangered healthcare workers during COVID-19. Representatives of the International Safety Equipment Association (ISEA), which includes the major manufacturers of N95 masks, told reporters today that they plan to ask the federal […]
FDA allows dry heat treatment for single-user mask reuse
The FDA has announced that it will allow the use of dry heat to lower the bioburden on masks used by healthcare workers treating COVID-19 patients. While not authorizing equipment made by a particular company, guidance released last week said healthcare providers may use dry heat to reprocess NIOSH-approved filtering facepiece respirators, such as N95s, […]
Regeneron antibody cocktail wins emergency use authorization
Regeneron Pharmaceuticals (NSDQ:REGN) has announced that the FDA has granted emergency use authorization (EUA) for the combination of casirivimab and imdevimab to treat COVID-19. The monoclonal antibody cocktail is reportedly the first treatment to show “statistically significant anti-viral activity” against COVID-19, according to its developer. In a trial, the combination of drugs cut hospitalization or emergency […]
