Tag: US FDA

shutdown

US government shutdown disrupting FDA work

The US government shutdown means the country’s Food and Drug Administration (FDA) cannot accept new user fees, which means the agency cannot accept new...

First United States treatment with J-Valve TAVI device

The first US patient has been successfully treated with JC Medical's transfemoral transcatheter aortic valve implantation (TAVI) device, the J-Valve TF system. The patient...

Sapien 3 Ultra receives FDA approval

It has been announced that the Sapien 3 Ultra system (Edwards Lifesciences) has received US FDA approval for transcatheter aortic valve implantation (TAVI) in...

FFRangio system receives US FDA clearance

US FDA 510(k) clearance has been granted for the FFRangio System (CathWorks). The FFRangio system demonstrated accuracy versus the invasive FFR wire in a...

First patients treated in United States with OrbusNeich Teleport Microcatheter

The first patients in the United States have been treated using the OrbusNeich Teleport Microcatheter (Teleport; Cardiovascular Systems), which recently received US Food and...

Europe braces for harder times in medical device innovation while US...

Countries in the European Union have long been the first to receive new innovations in medical technology, as the EU’s Medical Device Directive (MDD)...

US FDA agrees to 1000-patient pivotal trial of Armetheon’s tecarfarin

Armetheon has reached agreement with the US Food and Drug Administration (FDA) for a single 1000-patient final pivotal trial for its drug candidate, tecarfarin...

US FDA grants Fast Track designation to Angionetics’ Generx coronary heart...

The US Food and Drug Administration (FDA) has granted Angionetics “Fast Track” designation for the phase three clinical investigation of Generx cardiovascular angiogenic...

Robert Califf to resign as US FDA commissioner

Robert Califf is to step down as US Food and Drug Administration (FDA) commissioner upon the inauguration of Donald Trump as US President on...

US FDA bans powdered gloves

The US Food and Drug Administration (FDA) has issued a final rule to ban powdered surgical gloves, patient examination gloves and the absorbable powder...

NICE collaborates with US FDA on Payer Communication Taskforce

The UK’s National Institute for Health and Care Excellence (NICE) has announced its participation in the US Food and Drug Administration (FDA)’s Payer Communication...