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From Medical Design & Outsourcing

• MIT researchers may have invented a safer way of splitting ventilators
  MIT and Brigham and Women’s Hospital researchers say they have a way of splitting ventilators which could address many of the safety concerns — potentially boosting the supply of ventilators amid the COVID-19 pandemic. They have demonstrated their concept’s effectiveness in the lab — but they still caution it should be used only as a… […]
• What is a pulse oximeter — and how does it work?
  If you’re recovering from a respiratory problem — including COVID-19 — chances are you may have had your oxygen levels checked with a pulse oximeter. Pulse oximetry is the non-invasive measurement of oxygen saturation (SpO2). Oxygen saturation is defined as the amount of oxygen dissolved in the blood, based on the detection of Hemoglobin, Hb,… […]
• Tegra Medical CEO to retire
  Tegra Medical announced today that CEO J. Mark King will retire on Aug. 1, 2020. King is also retiring from his position as head of the medical division within the SFS Group, which acquired Tegra in 2016. King joined Tegra in 2012 as chief operating officer with more than 20 years of operations, sales, engineering… […]
• Steris wins second EUA to decontaminate up to 30m respirators per day
  Steris (NYSE:STE) has won an FDA emergency use authorization (EUA) for a new steam sterilization method to decontaminate used N95 respirators. The EUA covers the new Steris Steam Decon cycle to decontaminate 3M 1860, 3M 1860S, and 3M 1804 NIOSH-approved N95 respirators that are or might be contaminated with SARS-CoV-2 and other pathogenic microorganisms. The FDA… […]
• Raumedic supplies adhesive for production of thousands of ventilators
  When the federal government tapped Hamilton Medical to produce tens of thousands of ventilators for COVID-19 patients, the company turned to its long-term partner Raumedic for a special silicone adhesive. The adhesive is solvent- and plasticizer-free, easy to use and bonds silicones to each other and to other materials, such as metal or plastics, according… […]
• 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 accessories. The… […]
• Ga. warehouse workers sue Sterigenics, ConMed over EtO exposure
  Fifty-three people who worked in an Atlanta-area warehouse that stored medical devices sterilized by ethylene oxide (EtO) filed suit this week against Sterigenics and its parent company over exposure to the gas. The plaintiffs or their families claim that long-term EtO exposure to the sterilized devices, which they unloaded, handled, warehoused and distributed, caused multiple… […]
• FDA eases regs on certain device changes during pandemic
  The FDA will allow limited changes to certain devices so medtech companies can address manufacturing and supply chain issues due to COVID-19-related disruptions. In a guidance released yesterday, the agency said it would allow changes to devices approved through its premarket approval (PMA) and humanitarian device exemption (HDE) pathways as long as those changes do… […]
• 15 heart devices that could boost their manufacturers’ sales
  Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices. Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures. Now hospitals… […]
• This wearable could help people practice safe distancing amid COVID-19
  Imec spinoff Lopos, with the Ghent University (Belgium) announced the Lopos SafeDistance wearable for promoting safety during the COVID-19 pandemic. As businesses attempt to return to in-person activities, the collaboration designed the wearable device to warn employees through an audible or haptic alarm when they are violating social distancing guidelines as they approach each other.… […]
• FDA launches COVID-19 research initiative
  The FDA has entered an agreement with healthcare analytics company Aetion to research urgent questions about COVID-19. The New York City-based company said the research will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns using relevant, novel data sources and analyzing these data according to well-established principles.… […]