Approval for Xeltis’s aXess device was based on pivotal trial data that demonstrated 79% secondary patency and a patency related reintervention rate of 1.3 per patient year.
Johnson & Johnson (NYSE:JNJ) announced today that it received CE mark approval for its new Ethicon 4000 surgical stapler.
Philips (NYSE:PHG) announced today that it received FDA 510(k) clearance for its Rembra platform of scanning systems.
Sonorous Neurovascular announced today that it received FDA 510(k) clearance for its BosCATH next-generation neurovascular catheter.
Luminoah announced today that it received FDA clearance for Luminoah Flow, an enteral feeding system for those who rely on tube feeding.