FDA clears a Gynesonics 510(k) to market its next generation Sonata System 2.1 for Transcervical Fibroid Ablation.
Medtronic recalls (Class 1) its HeartWare Ventricular Assist Device Pump Outflow Graft and Outflow Graft Strain Relief because the outflow graft of th...
FDA releases a reference panel to support its evaluation of diagnostic tests for Covid-19.
Academic researchers propose a drug quality system to differentiate among products and manufacturers.
FDA posts upcoming and recent eMDR system enhancements.
FDA approves a new indication for Astellas VESIcare in an oral suspension to treat a type of bladder dysfunction in pediatric patients over age two.
FDA denies a petition asking it to investigate and take enforcement action against Edwards Lifesciences for marketing an annuloplasty ring without 510...
GlaxoSmithKline submits to FDA additional materials involving an assessment of its Zofran.