by TractManager | Nov 18, 2020 | News
The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home.The Lucira COVID-19 All-In-One Test Kit has been authorized for home use with self-collected nasal swab samples in...
by TractManager | Nov 17, 2020 | Health Technology Assessment
Focus of the Report: This health technology assessment focuses on the use of t:slim X2 Insulin Pump and Dexcom 6 continuous glucose monitoring (CGM) with Control-IQ closed-loop control (CLC) or Basal-IQ predictive low-glucose suspend (PLGS) technology for the...
by TractManager | Nov 16, 2020 | News
The Food and Drug Administration (FDA) is reporting on a recall of Cook Medical fixed core wire guides due to a manufacturing error. The Cook Medical fixed core wire guide is a curved wire made of stainless steel with non-reactive coating. The device helps insert and...
by TractManager | Nov 11, 2020 | News
The Food and Drug Administration (FDA) has announced a recall of the Trevo XP ProVue Retriever (Stryker Neurovascular) due to a safety risk.The Trevo XP ProVue Retriever is intended to restore blood flow or remove blood clots within a blood vessel in the brain during...
by TractManager | Nov 10, 2020 | News
The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bamlanivimab (Eli Lilly and Company) for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.Bamlanivimab is an investigational, intravenously...
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