COVID-19: Lucira Health Diagnostic Kit Granted First EUA For At-Home Self-Testing
In what could be a game-changer in the fight against the coronavirus, Lucira Health has received the first-ever emergency use authorization from the US FDA for an at-home prescription diagnostic test kit for detecting SARS-CoV-2.
You may also be interested in...
ASTM International is proposing a new standard that will provide a cleaning agent formula for removing dried blood from stainless steel medical devices.
Consensus report CR511 from the Association for the Advancement of Medical Instrumentation highlights common system elements for engineers, and outlines safety and risk-control measures that manufacturers and caregivers should consider.
The addition of the question “Was this device serviced by a third party servicer?” to adverse event reports filed through the US FDA’s electronic Medical Device Reporting system could prove helpful for the agency and device makers, experts tell Medtech Insight. Industry has long complained about poor work performed by servicers – and loudly groused that they’re not regulated.