Tag: FDA

Interventional News for specialists

CDRH adjusts working practices with medical device companies to deal with...

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has written to the medical device industry to outline its...
extended reality

LIVE blog: US FDA host public workshop on extended reality in...

The US Food and Drug Administration (FDA) is hosting a public workshop entitled "Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented...

Cerus Endovascular receives FDA approval for its first microcatheter

Cerus Endovascular receives FDA approval for its first microcatheter. The 021 microcatheter will be offered with three different distal configurations, and commercial sales are...
Interventional News for specialists

FDA issues guidance on PTA balloon and specialty catheter 510(k) submissions

The US Food and Drug Administration (FDA) has released draft guidance detailing the information device-makers should include in 510(k) submissions of catheter-based devices intended...
regulatory

With national regulatory approaches diverging, FDA urges “global consensus” at VIVA

Many regulatory jurisdictions are establishing different approaches for medical devices, Misti Malone, assistant director in the Office of Cardiovascular Devices at the US Food...

Medtronic receives FDA breakthrough device designation for its Valiant Navion LSA...

Medtronic today announced it has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Valiant TAAA stent graft system...

LimFlow receives FDA approval for US study of minimally-invasive technology designed...

LimFlow has announced that the US Food and Drug Administration (FDA) has approved its investigational device exemption (IDE) for the PROMISE II pivotal study of...

Orchestra BioMed announce FDA breakthrough device designation for Virtue sirolimus-eluting balloon

Orchestra BioMed, in partnership with Terumo Corporation, today announced that the company has secured breakthrough device designation by the US Food and Drug Administration...

FDA clears Artis icono family of angiography systems from Siemens Healthineers

The US Food and Drug Administration (FDA) has cleared the Artis icono, a family of angiography systems from Siemens Healthineers that permit a range...
Pipeline Flex

Medtronic statement regarding updated FDA letter to healthcare providers on paclitaxel...

Medtronic has issued the following statement regarding the US Food and Drug Administration’s (FDA) updated letter to healthcare providers for paclitaxel-devices in patients with...
FDA

FDA: Paclitaxel device clinical trials “may continue”; Agency is working to...

Clinical studies of paclitaxel-coated balloons and paclitaxel-eluting stents “may continue and should collected long-term safety (including mortality) and effectiveness data”, says the US Food...
lutonix

FDA notifies BD that Lutonix paclitaxel balloon PMA application for below...

The US Food and Drug Administration (FDA) have denied BD premarket approval (PMA) for the company’s Lutonix drug-coated balloon (DCB) in the treatment of...
Interventional News for specialists

FDA clears Shape Memory Medical’s Impede-FX embolization plug

The US Food and Drug Administration (FDA) has granted 510(k) clearance for the Impede-FX embolization plug (Shape Memory Medical). This device is available in...
CIRSE

CIRSE updates position on paclitaxel use in peripheral arteries

The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) has released a statement on the use of paclitaxel-coated balloons and stents in the treatment...
embosphere

Merit’s Embosphere microspheres receive expanded indication to control haemorrhaging in the...

The FDA has cleared an expanded indication of Embosphere microspheres (Merit Medical) for the embolization of blood vessels to occlude blood flow in the...
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...
MANTA

US FDA grants premarket approval of MANTA vascular closure device

The US Food and Drug Administration (FDA) has given premarket approval (PMA) for the MANTA vascular closure device from Teleflex. This device is the...

US FDA evaluating paclitaxel data, recommend patient surveillance

The impact of the 2018 meta-analysis of randomised paclitaxel-device trials, published in the Journal of the American Heart Association by Konstantinos Katsanos et al,...
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...

US FDA plan shakeup of its 510(k) clearance programme

The US FDA has announced plans to modernise its 510(k) clearance programme for approving medical devices for the US market. Data show that about...
Rivaroxaban

Rivaroxaban receives peripheral arterial disease indication in Europe and USA

Rivaroxaban (brand name Xarelto, Bayer) has received approval from the US Food and Drug Administration (FDA) and the European Commission to reduce risks in...

Valiant Navion thoracic stent graft receives FDA approval

The US Food and Drug Administration (FDA) has approved Valiant Navion thoracic stent graft system (Medtronic) for the minimally invasive repair of all lesions...
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...
warning

Cook Medical announces successful resolution of 2014 FDA warning letter

Cook Medical has announced that it received a close-out letter from the US Food and Drug Administration (FDA) resolving a 2014 warning letter for...

Impede embolization plug gets US FDA clearance

Shape Memory Medical announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Impede embolization plug. The device...

Thailand FDA approves new indication for Guerbet’s Lipiodol Ultra-Fluide

Guerbet has announced that the Thailand FDA has given approval of a new indication for Lipiodol Ultra-Fluide for selective hepatic intra-arterial injection for visualisation,...

US FDA grants Medtronic investigational device exemption for new In.Pact Admiral...

Medtronic has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate a study of the In.Pact Admiral...
Interventional News for specialists

Teleflex gets US FDA nod for Arrow VPS Rhythm with optional...

Teleflex has announced that its Arrow VPS Rhythm device with optional TipTracker technology has been issued 510(k) clearance so that the device can be...
recruiting

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...

Spectranetics gets CE mark for Stellarex 0.014” drug-coated balloon

Spectranetics has announced that its Stellarex 0.014” drug-coated angioplasty balloon has received the CE mark. The device is designed to treat small vessels, below-the...
Interventional News for specialists

Medtronic gets FDA clearance of new lower profile HawkOne 6F directional...

Medtronic has received US FDA 510(k) clearance for the HawkOne directional atherectomy system in a new size for treating patients with peripheral artery disease....

Medtronic receives US FDA clearance for TrailBlazer angled peripheral support catheter

Medtronic has announced that the US FDA has cleared the TrailBlazer angled support catheter for use in the peripheral vascular system. Support catheters such...
Interventional News for specialists

Cook Medical issues global recall of Roadrunner UniGlide hydrophilic wire guides...

The US Food and Drug Administration has announced that Dutch company DSM Biomedical BV—Cook Medical’s supplier of hydrophilic coating for the Roadrunner Uniglide hydrophilic...