Stereotaxis (NYSE:STXS) announced today that its Magbot magnetic navigation ablation catheter received regulatory approval in China. This nod comes just weeks after the company won approval from China’s National Medical Products Administration for the Genesis robotic magnetic navigation (RNM) system. St. Louis, Missouri-based Stereotaxis aims to … [Read more...] about Stereotaxis wins approval in China for magnetic ablation catheter
Regulatory
Lungpacer Medical wins FDA premarket approval for AeroPace neurostim system
Lungpacer Medical announced that it received FDA premarket approval for its flagship AeroPace neurostimulation system. AeroPace uses neurostimulation via an electrode-containing cardiovascular catheter and a software-controlled system. It delivers periodic phrenic nerve stimulation through the venous catheter. The system contracts and … [Read more...] about Lungpacer Medical wins FDA premarket approval for AeroPace neurostim system
InnoCare Urologics wins FDA nod for urinary safety catheter
InnoCare Urologics announced today that it received FDA 510(k) clearance for its novel urinary safety catheter. The Miami-based company says it marks the first-ever FDA clearance under a new code for urinary catheters with safety features. InnoCare designed its Egress safety catheter to eliminate the injuries that occur when traditional … [Read more...] about InnoCare Urologics wins FDA nod for urinary safety catheter
Route 92 Medical picks up CE mark for stroke portfolio
Route 92 Medical announced today that it received CE mark for its line of neurovascular intervention products for treating stroke. The company also picked up clearance under the MDSAP program, giving broad access to international markets. Authorization covers the majority of the company's products, including: HiPoint 70/Tenzing 7 … [Read more...] about Route 92 Medical picks up CE mark for stroke portfolio
Johnson & Johnson MedTech wins FDA nod for Varipulse PFA
Johnson & Johnson MedTech announced today that the FDA approved its Varipulse pulsed field ablation (PFA) platform for treating AFib. Varipulse treats AFib with a single device that combines PFA with the Carto 3 mapping system. With approval, Johnson & Johnson joins Medtronic and Boston Scientific as companies with PFA technologies … [Read more...] about Johnson & Johnson MedTech wins FDA nod for Varipulse PFA
R3 Vascular wins FDA IDE for drug-eluting scaffold
R3 Vascular announced today that the FDA granted investigational device exemption (IDE) to evaluate its Magnitude drug-eluting bioresorbable scaffold. Mountain View, California-based R3 Vascular designed Magnitude for treating below-the-knee (BTK) peripheral arterial disease (PAD). With the FDA granting IDE, it can now initiate the ELITE-BTK … [Read more...] about R3 Vascular wins FDA IDE for drug-eluting scaffold
Vantis Vascular wins FDA nod for integrated microcatheter guide extension system
Vantis Vascular announced today that it received FDA 510(k) clearance for its CrossFast integrated microcatheter guide extension system. San Jose, California-based Vantis develops the CrossFast system along with the CrossShock intravascular lithotripsy (IVL) system. It designed CrossFast to help physicians perform faster, easier and safer … [Read more...] about Vantis Vascular wins FDA nod for integrated microcatheter guide extension system
FDA approves IDE for Medtronic Prevail drug-coated balloon
Medtronic (NYSE: MDT) announced today that it received FDA investigational device exemption (IDE) for its Prevail drug-coated balloon (DCB). The medtech giant can now begin a pivotal clinical trial for the coronary paclitaxel DCB for in-stent restenosis (ISR) and de novo small vessel disease. It plans to use data from its Prevail Global Clinical … [Read more...] about FDA approves IDE for Medtronic Prevail drug-coated balloon
Peytant wins FDA de novo nod for covered stent system
Peytant Solutions announced today that the FDA granted marketing authorization for its AMStent tracheobronchial covered stent system. Plymouth, Minnesota-based Peytant designed its AMStent to treat pulmonary obstructions caused by cancer. The novel, proprietary therapy platform is indicated for treating tracheobronchial strictures produced by … [Read more...] about Peytant wins FDA de novo nod for covered stent system
Boston Scientific warns on some PolarX cryoablation catheters following reports of death
Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] issued an urgent field safety notice in Europe to notify customers of updates to its PolarX cryoablation catheters. Marlborough, Massachusetts-based Boston Scientific's notice relates to the PolarX and PolarX FIT cryoablation catheters. These systems work as part of the PolarX … [Read more...] about Boston Scientific warns on some PolarX cryoablation catheters following reports of death
