Tag: US 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US FDA issues first draft guidance for AI-based medical device development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...
FDA issues two final guidances for including patient perspectives in medical device studies
The US Food and Drug Admi...
FDA issues new policy on remote monitoring devices for use during COVID-19 pandemic
The US Food and Drug ...
FDA issues update on reducing the risk of patient infections during cardiac surgery
The US Food and Drug Admi...
SeQuent Please ReX drug-coated PTCA balloon catheter receives FDA breakthrough device designation
B Braun Interventional Sy...
First patients treated in United States with OrbusNeich Teleport Microcatheter
The first patients in the...
Europe braces for harder times in medical device innovation while US FDA eases regulations
Countries in the European...
US FDA grants Fast Track designation to Angionetics’ Generx coronary heart disease gene therapy
The US Food and Drug Admi...
