Stereotaxis (NYSE:STXS) said today that it has secured CE mark approval for its Magic robotically-navigated magnetic ablation catheter. The St. Louis–based robotic surgery company submitted Magic for both CE mark and FDA approval nearly a year ago; it still awaits an FDA nod in the U.S. Magic performs cardiac ablation procedures to treat heart arrhythmia. […]
CE Mark
Medtronic gets CE mark for Harmony transcatheter pulmonary valve
Medtronic today announced CE mark approval for its Harmony transcatheter pulmonary valve (TPV) system. About 1.3 children around the world each year are born with congenital heart disease, according to the Minneapolis-based nonprofit Children’s HeartLink. The Harmony system provides a minimally invasive alternative to open-heart surgery for congenital heart disease patients with native or surgically […]
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 Reperfusion System HiPoint 88/Tenzing 8 Reperfusion System […]
Abbott wins CE mark for dual-chamber leadless pacemaker
Abbott announced today that it received CE mark approval for its Aveir dual-chamber (DR) leadless pacemaker system. Aveir DR, the world’s first dual-chamber leadless pacemaker, treats people with abnormal or slow heart rhythms. It enables a beat-to-beat, wireless communication channel between two leadless pacemakers. One paces the right ventricle (Aveir VR) and the other paces […]
Getinge wins European approval for covered stent system
Getinge announced today that it received EU MDR certification for its Advanta V12 covered stent system for patients with aortoiliac occlusive disease (AIOD). The balloon-expandable covered stent’s indication aligns with AIOD, which includes treating lesions at the aortic bifurcation. Getinge said EU MDR certification highlights its dedication to providing safe, effective, high-quality products. With the […]
Medtronic wins CE mark for MiniMed 780G with Simplera Sync disposable, all-in-one CGM
Medtronic announced today that it received CE mark approval for its MiniMed 780G system with Simplera Sync. Simplera Sync, a disposable, all-in-one continuous glucose monitor (CGM), eliminates the need for fingersticks and overtape. It features an improved user experience at half the size of previous Medtronic sensors with a simple, two-step insertion process. MiniMed 780G, […]
Medtronic wins CE mark for rechargeable deep brain stimulation tech
Medtronic announced that it received CE mark approval for its Percept RC neurostimulation device. The medtech giant labeled the deep brain stimulation (DBS) device as the smallest and thinnest device on the market. Also rechargeable, the system features BrainSense sensing technology. Medtronic says its launch marks the first release of a rechargeable DBS system with […]
Edwards wins CE mark for Evoque tricuspid valve replacement
Edwards Lifesciences announced today that it received CE mark for its Evoque tricuspid valve replacement system. Irvine, California-based Edwards says the regulatory nod makes it the first transcatheter valve replacement therapy to receive approval to treat tricuspid regurgitation (TR). Evoque features a nitinol self-expanding frame and an intra-annular sealing skirt. It makes the device’s tissue […]
Medtronic wins CE mark for next-gen Simplera CGM with InPen integration
Medtronic announced today that it received CE mark approval for its new Simplera continuous glucose monitor (CGM). The all-in-one, disposable CGM features a simple, two-step insertion process for people with diabetes using multiple daily injections (MDI). Medtronic’s newest no-fingerstick sensor eliminates the need for overtape, too. It seamlessly integrates with the InPen smart insulin pen […]
Moon Surgical picks up CE mark for updated Maestro surgical robot
Moon Surgical announced today that it received CE mark approval in Europe for the latest version of its Maestro surgical robot system. The initial version of Maestro received CE mark approval earlier this year in April. This milestone marks the latest in a string of positive updates for Moon Surgical, which raised $55.4 million in […]
Quantum Surgical wins CE mark to treat lung tumors with its surgical robot
Quantum Surgical recently announced that it received expanded CE mark approval for the use of its Epione surgical robotic platform. The Montpellier, France–based company won expanded indications for Epione in the treatment of lung tumors. Epione, the company’s flagship product, offers curative treatment for cancers. Quantum Surgical designed it to plan, target, deliver and confirm […]