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Battelle Memorial Institute

FDA revokes Battelle mask decontamination EUA

May 3, 2021 By Nancy Crotti

The FDA has revoked its authorization for Battelle Memorial Institute to decontaminate used N95 respirators for healthcare workers. In a letter dated April 30, 2021, the agency said it revoked the EUA at Battelle’s request. The Columbus, Ohio-based research organization asked to withdraw the EUA for its Critical Care Decontamination System (CCDS) in an April 2 letter. […]

Filed Under: Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Battelle, Battelle Memorial Institute, coronavirus, FDA

FDA warns Battelle on reporting mask decontamination problems

October 7, 2020 By Nancy Crotti

The FDA is warning Battelle Memorial Institute that it must improve its adverse event reporting procedure for decontaminating N95 masks for reuse by frontline healthcare workers treating COVID-19 patients. The agency granted an emergency use authorization (EUA) in March for the Battelle Critical Care Decontamination System (CCDS), which uses vaporized hydrogen peroxide to reprocess used N95 […]

Filed Under: Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Respiratory Tagged With: Battelle Memorial Institute, Center for Devices and Radiological Health (CDRH), coronavirus, COVID-19, FDA

DARPA grants $23M contract to Battelle, NxStage and Aethlon for a sepsis treatment

July 25, 2013 By Sony Salzman Leave a Comment

DARPA hands a $23M contract to Battelle, NxStage and Aethlon for a sepsis treatment

Filed Under: Blood Management, News Well Tagged With: Aethlon Medical Inc., Battelle Memorial Institute, Deals Roundup, Defense Advanced Research Projects Agency (DARPA), Dialysis, NxStage Medical Inc.

Welch Allyn, Battelle Memorial, others land U.S. Defense Dept. deals

June 21, 2013 By Sony Salzman Leave a Comment

Department of Defense logo

The U.S. Defense Dept. handed out contracts worth millions of dollars for medical devices and research to Welch Allyn, Battelle Memorial Institute and 2 radiology companies.

Filed Under: News Well, Patient Monitoring Tagged With: Battelle Memorial Institute, defensedepartment, Dialysis, MinXray, Virtual Imaging, Welch Allyn

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