Penumbra (NYSE:PEN) has received FDA clearance and launched its Ruby XL system for embolization procedures. The Alameda, California-based device maker launched the platform as a new option for physicians treating high-flow or large-vessel cases. The Ruby XL system includes three new coils that are compatible with 0.035-inch diagnostic catheters … [Read more...] about Penumbra launches Ruby XL coil system for large vessel embolization
Medtronic has a serious tracheostomy tube recall
Medtronic (NYSE: MDT) is recalling specific lots of its Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff and reusable inner cannula due to an issue that could pose serious health risks. The FDA labeled the recall as Class I, the most serious kind, because the device’s securement flange may detach from the cannula, potentially … [Read more...] about Medtronic has a serious tracheostomy tube recall
FastWave Medical reports first-in-human use of coronary laser IVL system
FastWave Medical has completed the first human procedures with its Sola coronary laser intravascular lithotripsy system. The company said that these initial procedures marked the start of its multi-center feasibility study evaluating the platform’s safety and performance. [Scott Nelson, FastWave Medical’s co-founder and CEO, will participate in a … [Read more...] about FastWave Medical reports first-in-human use of coronary laser IVL system
Terumo Neuro launches Sofia Flow 88 for stroke care, expanding aspiration catheter line
Terumo Neuro (formerly MicroVention) has launched the Sofia Flow 88 large-bore aspiration catheter, designed for supporting clot removal in stroke procedures. The catheter features a 0.088 in. inner diameter and incorporates design enhancements aimed at improving procedural control, vessel safety, and compatibility across aspiration … [Read more...] about Terumo Neuro launches Sofia Flow 88 for stroke care, expanding aspiration catheter line
Reflow Medical wins FDA de novo clearance for Spur stent
Reflow Medical today announced it received FDA de novo clearance for its Spur Peripheral Retrievable Stent System for infrapopliteal arterial disease. The system is cleared for use in de novo or restenotic lesions following predilatation in below-the-knee (BTK) vessels. It combines a self-expanding stent with an integrated balloon catheter on an … [Read more...] about Reflow Medical wins FDA de novo clearance for Spur stent
Terumo begins limited release of Roadsaver carotid stent following FDA nod
Terumo Interventional Systems has announced the early commercial availability of its FDA-approved Roadsaver Carotid Stent System. Roadsaver is a dual-layer micromesh carotid stent designed to reduce embolic risk during carotid artery stenting (CAS) procedures. It is indicated for use in patients with carotid artery stenosis who are at increased … [Read more...] about Terumo begins limited release of Roadsaver carotid stent following FDA nod
Stereotaxis submits pair of catheters for FDA clearance
Stereotaxis today announced it submitted its EMAGIN 5F and MAGiC catheters for FDA clearance. EMAGIN 5F, short for Endovascular Magnetic Intervention, is a 5-French diameter catheter that navigates tortuous venous and arterial vasculature. Stereotaxis designed it to enable efficient and safe navigation to access difficult-to-reach vascular … [Read more...] about Stereotaxis submits pair of catheters for FDA clearance
Autonomix secures U.S. patent for cancer-treating tech
Autonomix this week announced it received a patent from the U.S. Patent and Trademark Office (USPTO) for its catheter-based cancer tumor treating technology. The patent, titled Systems and Methods for Treating Cancer and/or Augmenting Organ Function, covers the company technology, including systems, methods, and devices for interventionally … [Read more...] about Autonomix secures U.S. patent for cancer-treating tech
Anteris Technologies launches IPO to support heart valve technology
Anteris Technologies today announced the launch of its initial public offering in the U.S. The company aims to raise funds through the IPO to advance the development of its DurAVR transcatheter heart valve technology. Anteris’ IPO consists of 14.8 million shares of common stock, with an additional 2.22 million shares available to underwriters … [Read more...] about Anteris Technologies launches IPO to support heart valve technology
Zeus appoints Tim Sette as CFO
Zeus today announced it appointed Tim Sette as chief financial officer. Sette will be responsible for driving the polymer extrusion and catheter manufacturing company's financial strategy and operational performance as the company continues to accelerate growth post-acquisition. He has more than a decade of experience in the medical device … [Read more...] about Zeus appoints Tim Sette as CFO
