Tag: US FDA

Gottlieb

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...
ProVu

Acessa Health wins FDA nod for 3rd generation ProVu

Acessa Health has announced that the company has received US Food and Drug Administration (FDA) 510(k) clearance for its third generation Acessa ProVu radiofrequency ablation...

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...
Purple drug-coated balloon in an s shape

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)...
Purple Embozene microspheres

Embozene microspheres are now indicated for prostate artery embolization

Boston Scientific showed at the Global Embolization Cancer Symposium and Technologies (GEST US; 17–19 May, Miami Beach, USA) meeting that the US Food and...

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....

XableCath gets US FDA clearance for broadly effective catheter aimed at...

XableCath has announced its XableCath blunt tip support catheter has received clearance from the US FDA. The blunt tip catheter facilitates true lumen passage...

Study finds no evidence that gadolinium causes neurologic harm

There is no evidence that accumulation in the brain of the element gadolinium speeds cognitive decline, according to a new study presented at the...

US FDA clears first 7T magnetic resonance imaging device

The US Food and Drug Administration has cleared the first seven tesla (7T) magnetic resonance imaging (MRI) device, more than doubling the static magnetic...

Bard gets US FDA premarket approval for Lutonix 035 DCB in...

Bard’s Lutonix 035 drug-coated balloon PTA catheter (DCB) has been granted premarket approval (PMA) by the US Food and Drug Administration (FDA) for a...

Spectranetics announces FDA approval of Stellarex drug-coated balloon

Spectranetics has announced receipt of US Food and Drug Administration (FDA) premarket approval of the Stellarex drug-coated balloon (DCB), designed to restore and maintain...

Embosphere receives US FDA de novo classification for prostatic artery embolization

Merit Medical has announced that it has received 513(f)(2) (de novo) classification from the FDA to expand indication for its Embosphere microspheres. The indication...

First patient enrolled in IN.PACT arteriovenous access drug-coated balloon study

The US FDA has approved the investigational device exemption (IDE) study to evaluate the safety and efficacy of IN.PACT AV access drug-coated balloon as...

Mirabilis announces European approval for non-invasive uterine fibroid treatment

Mirabilis has announced CE mark authorisation to market the Mirabilis System in the European Union. The system combines high-speed therapeutic ultrasound technology with an...

BTG receives US FDA 510(k) clearance for Ekos control unit 4.0

BTG has announced that US FDA 510(k) clearance has been granted to the Ekos control unit 4.0. The Ekos system includes an ultrasonic device...

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...

NICE collaborates with US FDA on Payer Communication Taskforce

  NICE’s Scientific Advice programme will work with companies looking to attain both FDA approval and payer coverageThe UK’s National Institute for Health and Care...

Final patient enrolled for VIVO iliofemoral venous stent study

Cook Medical has completed enrolment in the first clinical study of an iliofemoral venous stent conducted in the USA under a US FDA-approved investigational device exemption. The...

Merit Medical receives 510(k) clearance for the SwiftNinja steerable microcatheter

Merit Medical Systems has received 510(k) clearance for the  SwiftNinja steerable microcatheter, covering peripheral and coronary applications. With the exception of Japan, Merit has global...

Teleflex receives US FDA clearance for Arrow and TightTrack tunneler

Teleflex has announced that it has received US FDA 510(k) clearance to market its Arrow JACC with Chlorag+ard technology and TightTrack tunneler. Arrow JACC...

First US commercial placements of Angel catheter

Bio2 Medical has announced that the Angel catheter, a new device for the prevention of pulmonary embolism, was placed in two patients at St...