FDA expects that any COVID-19 vaccine it licenses should prevent the disease or decrease its severity in at least 50% of people vaccinated, according to guidance that the agency released today. The recommendation, which FDA said reflects the advice the agency has provided vaccine developers in recent months, was part of an overall document called […]
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Perimeter Medical Imaging to go public in Toronto
Perimeter Medical Imaging — creator of AI-based medical imaging tools for cancer surgery — plans to go public on the TSX Venture Exchange in Toronto on the week of June 29. The Toronto- and Dallas-based company is going public at the same time that it enters the commercial stage for its proprietary, FDA-cleared OCT imaging […]
Medtronic recall of DBS placement software is Class I
FDA said today that a Medtronic (NYSE:MDT) recall of software used to help place deep brain stimulation systems is Class I, the agency’s most serious level. The company in August 2019 recalled the auto-registration feature of its StealthStation DBS software due to inaccuracies caused by minor patient movements during the auto-registration process when used with NexFrame […]
Zoll Medical hit with dozens of COVID-19 cases
Zoll Medical‘s Pawtucket, R.I. facility — which manufacturers parts for ventilators and defibrillators — has seen 75 cases of COVID-19, according to a report in The Providence Journal. Zoll learned of the outbreak in late March, sending all the plant workers home April 2–6 as it cleaned the facility and reoriented the workspace, Zoll Medical […]
ResMed launches remote ventilator monitoring in Europe
ResMed (NYSE:RMD) announced today an accelerated launch of cloud-based remote monitoring software for ventilators and Lumis bilevel devices across Europe. The San Diego–based maker of respiratory support devices has been among a host of ventilator makers rushing to meet demand amid the COVID-19 pandemic. But the company noted that there are also many other people who […]
NIH says still no drug proven safe, effective for treating COVID-19
The National Institutes of Health today announced the publishing of new COVID-19 treatment guidelines, and the expert panel producing the guidelines says no drug has yet been proven safe and effective against the virus. NIH has the new guidelines posted online at covid19treatmentguidelines.nih.gov — and says it will update the guidelines often as new peer-reviewed […]
Stryker gains emergency nod for respirator decontamination
The FDA has granted Stryker (NYSE:SYK) an emergency use authorization to decontaminate used N95 respirators using the company’s Sterizone VP4 sterilizer during the coronavirus outbreak. The Sterizone VP4 uses vaporized hydrogen peroxide to sterilize up to 20 of the masks in one cycle, according to the FDA. Stryker’s sterilizer is the fourth that uses vaporized hydrogen […]
U.S. Defense Department using Defense Production Act to boost N95 masks supply
The U.S. Defense Department is using the Korean War-era Defense Production Act to boost the nation’s supply of N95 respirator masks by 39 million over the next 90 days. Defense Secretary Mark T. Esper made the announcement yesterday, saying the $133 million contract would “ensure our government has the industrial capacity to meet the nation’s […]
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 […]
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, […]
Dupont to deliver millions of Tyvek suits to aid coronavirus fight
The U.S. Department of Health and Human Services says DuPont has agreed to deliver 450,000 Tyvek suits to the U.S. this week to protect healthcare workers fighting the COVID-19 pandemic. Along with an N95 respirator or surgical/face mask, a face shield or protective eyewear, and gloves, a Tyvek coverall suit is an important piece of […]
