Tag: US FDA

FDA clears Aspire MAX mechanical thrombectomy system

Control Medical Technology has announced that the US Food and Drug Administration (FDA) has cleared its Aspire MAX 7 – 11F mechanical thrombectomy...
bluegrass vascular trial results

FDA grants de novo clearance to Bluegrass Vascular for Surfacer system

Bluegrass Vascular Technologies (Bluegrass Vascular) announced today that the US Food and Drug Administration (FDA) has granted a de novo classification order for its...

Scott Gottlieb resigns as head of US FDA

The commissioner of the US Food and Drug Administration (FDA), Scott Gottlieb, has unexpectedly resigned after serving just shy of two years in the...
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...

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)...

LimFlow completes enrolment in US feasibility study

LimFlow has announced completion of enrolment of the original 10-patient cohort in the US feasibility study of the LimFlow percutaneous deep vein arterialisation system....
Venous News for specialists

US FDA approves betrixaban anticoagulant for hospital and extended duration prophylaxis...

The US Food and Drug Administration (FDA) has approved betrixaban (Bevyxxa, Portola), the first and only anticoagulant for hospital and extended duration prophylaxis (35...
Robert Califf with Venous News

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...
Powdered gloves must be replaced by non-powdered alternatives, following the ban

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’s Scientific Advice programme will work with companies looking to attain both FDA approval and payer coverage

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...