Tag: US FDA

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...

TOBA II shows repairing dissections after angioplasty “clearly augments” outcomes for...

Thomas Zeller (Bad Krozingen, Germany) delves into data and design of the TOBA II (Tack Optimized Balloon Angioplasty II) trial with principal investigator William...

BD acquires TVA Medical, makers of everlinQ endoAVF System

BD (Becton, Dickinson and Company) announced it has completed the acquisition of TVA Medical, a company that develops minimally invasive vascular access solutions...

Medtronic receives US FDA clearance for 200mm and 250mm IN.PACT Admiral...

Medtronic has announced that it has received US FDA approval for 200mm and 250mm lengths of the IN.PACT Admiral drug-coated balloon (DCB) to treat...

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 clears CorPath GRX system for use in peripheral vascular...

Corindus has announced receiving 510(k) clearance from the US Food and Drug Administration (FDA) for use of the CorPath GRX system in peripheral vascular...

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....

US FDA approves Gore Viabahn expandable stent graft for iliac artery...

The Gore Viabahn VBX balloon expandable endoprosthesis has received US Food & Drug Administration (FDA) approval for treatment of de novo or restenotic lesions found...

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...