Tag: FDA
US FDA warns thousands of companies and researchers against suppressing unfavourable trial results
The US Food and Drug Admi...
US FDA issues first draft guidance for AI-based medical device development
The US Food and Drug Admi...
SCAI statement seeks to guide physician operators and facilities on renal denervation use
The Society for Card...
FDA issues two final guidances for including patient perspectives in medical device studies
The US Food and Drug Admi...
CDRH adjusts working practices with medical device companies to deal with COVID-19
The US Food and Drug Admi...
Revivent transcatheter system receives Breakthrough Device Designation from the FDA
The Revivent transcat...
US FDA designates Medtronic HVAD system controller field action as class I recall
The US Food and Drug ...
US FDA grants Fast Track designation to Angionetics’ Generx coronary heart disease gene therapy
The US Food and Drug Admi...
US FDA issues Class I recall for 8040 Leonhard Lang multifunction defibrillation electrodes
The Leonhard Lang def...
