Contaminated Gas Risk Leads To Worldwide Ventilator Recall
German medical technology firm Drägerwerk announced a worldwide recall in August of its Drager brand ventilators after tests revealed potential contamination of the gas used with the devices.
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The US FDA has issued final guidance to assist developers in preparing various applications for medical devices that come in contact with the human body. The guidance also seeks to clarify the use of international standards in assessing device biocompatibility.
This week, NIST published a new version of its international cybersecurity standard; SeaStar Medical’s kidney device got an HDE; and the FDA announced safety issues for DT MedTech LLC, operating room tables, and GE incubators.
News We’re Watching: Smart Watch Blood Glucose Warning, $100M For Women’s Health, Zimmer Surgical Robot Clearance
This week, the FDA reminded consumers that smart watches and rings are not blood glucose monitors; First Lady Jill Biden announced a $100M women’s health initiative; and the Zimmer ROSA Shoulder System got FDA clearance.