Tag: FDA

‘Nearly nothing’ in surgery will go untouched by AI, ACS Clinical...

Almost nothing will go untouched by artificial intelligence (AI) in healthcare and surgery, notably in the quickly evolving world of vascular and endovascular surgery,...

Vascular surgeons encouraged to consult talking points document on paclitaxel devices

Vascular surgeons are being encouraged to take consideration of a set of talking points about the risks and benefits of paclitaxel-equipped devices—which has been...

Terumo Aortic gains FDA approval for Treo endovascular device

Terumo Aortic has been granted Food and Drug Administration (FDA) approval for the Treo abdominal aortic stent-graft system to be sold in the U.S. The...

First US commercial use of Tack Endovascular System in BTK arteries...

Intact Vascular has announced the first commercial use of its Tack Endovascular System (4F) in multiple sites across the United States. Notably the first Food...

FDA grants Nexus aortic arch stent graft system breakthrough designation

Endospan was recently granted breakthrough device designation from the Food and Drug Administration (FDA) for the Nexus aortic arch stent graft system. The FDA’s breakthrough...

FDA official delivers government agency’s early reaction to latest contentious meta-analysis...

HOLLYWOOD, Fla.—A Food and Drug Administration (FDA) official delivered a talk which represents the government agency’s earliest public reaction to the latest meta-analysis suggesting...

Early adaptation of SVS, STS TBAD joint document will drive robust...

The Society for Vascular Surgery (SVS) and the Society of Thoracic Surgeons (STS) recently published a joint document on reporting standards for type B...

Newly FDA-approved device for central venous occlusions hailed as exciting advance

HOUSTON—These are exciting times in the theater of dialysis access, expert in the field Eric Peden, MD, mused in the latter part of last...
x-ray image below knee amputation or BKA amputation

Deploying robust, detailed SVS VQI data to help better define role...

In December 2018, the Journal of the American Heart Association published “Risk of death following application of paclitaxel‐coated balloons and stents in the femoropopliteal...

FDA keeps close watch on heparin dosing reports

The Food and Drug Administration (FDA) is closely monitoring reports of higher than usual doses of heparin being required to achieve activated clotting times...

SVS president presents point-by-point defense of Society position on paclitaxel controversy

NEW YORK—Kim Hodgson, MD, president of the Society for Vascular Surgery, delivered a robust defense of the SVS position on the drug-coated balloon (DCB)...

Regulatory unity can help drive medical device adoption globally, FDA official...

LAS VEGAS—Efforts at international collaboration across borders can drive harmony among disparate regulatory requirements and lead to greater global cooperation at the medical device...