FDA’s CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet later this year to examine the safety of endovascular stent grafts made by Endologix and other companies. Day one of the meeting will examine the benefit-risk profile of the Endologix AFX endovascular graft system regarding a potentially … [Read more...] about FDA committee to examine safety of endovascular stent grafts
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Cook Medical has a serious catheter recall
FDA has designated Cook Medical's recall of its Flexor Check-Flo introducers and Flexor tuohy-borst side-arm introducers as Class I, its most serious level. Cook Medical initiated the recall on Nov. 24. It involves 37,326 of the devices, which are used to deliver medical devices to blood vessels (though not vessels of the heart and brain). The … [Read more...] about Cook Medical has a serious catheter recall
SoniVie wins FDA breakthrough nod for renal denervation tech
SoniVie announced that it received FDA breakthrough device designation for its Tivus renal artery denervation technology. Tivus (therapeutic intra-vascular ultrasound system) is designed for treating resistant hypertension through renal artery denervation. The system previously received breakthrough designation for treating pulmonary arterial … [Read more...] about SoniVie wins FDA breakthrough nod for renal denervation tech
NanoVibronix device gains FDA nod for import to U.S.
NanoVibronix (NSDQ:NAOV) announced that it received FDA enforcement discretion for the U.S. distribution of the UroShield device. According to a news release, the FDA exercised its enforcement discretion, giving Elmsford, N.Y.-based NanoVibronix’s UroShield an intended use code (IUC), clearing the way for the import of the system to the U.S. … [Read more...] about NanoVibronix device gains FDA nod for import to U.S.
FDA labels Applied Medical catheter recall as Class I
The FDA announced yesterday that the Applied Medical recall of multiple kinds of its catheters is designated as Class I, the most serious type of recall. The Python embolectomy catheters, Bard embolectomy catheters and the OTW Latis cleaning catheters were the types recalled by Applied Medical. A total of 19,400 devices were recalled in the … [Read more...] about FDA labels Applied Medical catheter recall as Class I
Vascular Solutions recall of Langston dual lumen catheter is Class I
The FDA issued a notice today warning that its recall of the Vascular Solutions Langston dual lumen catheter is identified as Class I, the most serious kind of recall. Vascular Solutions, a Teleflex (NYSE:TFX) subsidiary, designed the Langston dual lumen catheter for the rapid delivery of dye into blood vessels during medical imaging tests, … [Read more...] about Vascular Solutions recall of Langston dual lumen catheter is Class I
Could these DIY ventilators stop coronavirus from killing people?
Amid the global crisis caused by the coronavirus pandemic, hospitals and healthcare facilities are reporting shortages of vital equipment that not only keeps the patients safe, but the staffers, too. One important device for which demand has ramped up is ventilators for patients who need assistance with their breathing due to the respiratory … [Read more...] about Could these DIY ventilators stop coronavirus from killing people?
Boston Scientific has a Class I recall of angiographic catheters
The FDA has issued a Class I designation for a recall involving the Imager II 5F angiographic catheters produced by Boston Scientific (NYSE:BSX). Marlborough, Mass.-based Boston Scientific’s catheters are designed to provide a pathway for delivering contrast agents to blood vessels including carotid arteries. Get the full story at our sister … [Read more...] about Boston Scientific has a Class I recall of angiographic catheters
LeMaitre Vascular recall of embolectomy catheters is Class I
The FDA identified the recall of LeMaitre Vascular (NSDQ:LMAT) Over the Wire embolectomy catheters for a failure to deflate as a Class I recall. Burlington, Mass.–based LeMaitre Vascular's Over the Wire embolectomy catheter is indicated for use in the surgical removal of blood clots that are lodged in a blood vessel (emboli) and blood clots that … [Read more...] about LeMaitre Vascular recall of embolectomy catheters is Class I
Bluegrass Vascular Technologies wins de novo nod for ‘inside-out’ vascular access catheter
Bluegrass Vascular Technologies announced that it won FDA de novo clearance for its Surfacer inside-out access catheter system. The Surfacer is designed to obtain central venous access through its inside-out approach, facilitating catheter insertion to the central venous system in people with upper body venous occlusions or other conditions that … [Read more...] about Bluegrass Vascular Technologies wins de novo nod for ‘inside-out’ vascular access catheter
