CereVasc announced today that it received FDA breakthrough device designation for its eShunt system for treating normal pressure hydrocephalus (NPH). The company said data generated during pilot clinical studies of the device supported the breakthrough device designation. This designation enables priority review and enhanced communication with … [Read more...] about CereVasc wins FDA breakthrough nod for eShunt system
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FDA clears Siemens Healthineers’ AI-powered cardiovascular ultrasound and catheter
Siemens Healthineers announced today that it received FDA clearance for its Acuson Origin ultrasound system and AcuNav Lumos 4D ICE catheter. Acuson Origin, a new, dedicated cardiovascular ultrasound, includes AI-powered features. It can help physicians perform cardiac procedures more efficiently in the areas of diagnostics, structural heart … [Read more...] about FDA clears Siemens Healthineers’ AI-powered cardiovascular ultrasound and catheter
Medtronic endotracheal tubes recall sparks an FDA warning
The FDA issued a notice instructing healthcare providers to stop using certain reinforced endotracheal tubes made by Medtronic (NYSE:MDT). This warning extends to NIM Contact EMG reinforced endotracheal tubes and NIM (Standard) EMG reinforced endotracheal tubes. Medtronic offers the neural integrity monitor (NIM) electromyogram (EMG) tubes for … [Read more...] about Medtronic endotracheal tubes recall sparks an FDA warning
Teleflex has a serious balloon catheter recall, 3 deaths linked to issue
The FDA says a recall of Teleflex (NYSE:TFX) intra-aortic balloon (IAB) catheter kits is Class I, the most serious kind of recall. Teleflex recalled its Arrow FiberOptix IAB catheter kit and Arrow UltraFlex IAB catheter kit. This recall is a correction, not a product removal. However, the issues related to the kits resulted in reports of 31 … [Read more...] about Teleflex has a serious balloon catheter recall, 3 deaths linked to issue
Xeltis wins FDA IDE approval for restorative vascular access conduit pivotal trial
Xeltis announced today that it received FDA investigational device exemption (IDE) to begin a pivotal study of its restorative vascular access conduit. aXess enables the creation of a new, permanent, living vessel for hemodialysis vascular access. It combines the safety and patency of arteriovenous fistula (AVF) with the speed to treatment of … [Read more...] about Xeltis wins FDA IDE approval for restorative vascular access conduit pivotal trial
Atraverse wins FDA nod for left-heart access device, raises $12.5M
Atraverse Medical announced today that the FDA cleared its Hotwire radiofrequency guidewire left-heart access device. The novel device enables zero exchange left-heart access while acting as a rail for catheter-based therapy systems. Steven Mickelsen, the founder of Farapulse, invented the Hotwire system with co-founder Eric Sauter. It's the … [Read more...] about Atraverse wins FDA nod for left-heart access device, raises $12.5M
CereVasc can begin new IDE study of eShunt
CereVasc announced today that it received FDA investigational device exemption (IDE) approval to begin a pivotal study of its eShunt. The FDA said the Boston-based company can initiate the STRIDE pivotal study looking at eShunt in treating normal pressure hydrocephalus. IDE approval allows the company look at the novel system's safety and … [Read more...] about CereVasc can begin new IDE study of eShunt
Abbott wins FDA approval for dissolving drug-eluting scaffold
Abbott announced today that the FDA approved its Espirit everolimus-eluting resorbable scaffold system. The Espirit scaffold treats chronic limb-threatening ischemia (CLTI) below the knee (BTK). Abbott designed it to keep arteries open and deliver everolimus to support vessel healing prior to completely dissolving. Abbott says that before … [Read more...] about Abbott wins FDA approval for dissolving drug-eluting scaffold
Fresenius Medical Care recalls more than 2 million catheter components
The FDA says a recall of Fresenius Medical Care catheter extension sets and luer lock adapters is Class I, the most serious kind. Fresenius Medical Care initiated the recall of a number of its Stay-Safe luer lock adapters and catheter extensions on Jan. 23, 2024. It extends to nearly 2.2 million devices distributed between March 5, 2003, and … [Read more...] about Fresenius Medical Care recalls more than 2 million catheter components
FDA approves Boston Scientific’s Agent drug coated balloon
Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] announced today that it received FDA approval for its Agent drug-coated balloon (DCB). The DCB won approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented … [Read more...] about FDA approves Boston Scientific’s Agent drug coated balloon
