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 […]
CE Mark
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 […]
Medtronic wins CE mark for Inceptiv spinal cord stimulation system
Medtronic announced today that it received CE mark approval for its Inceptiv spinal cord stimulator (SCS). Inceptiv, a closed-loop, rechargeable SCS, treats chronic pain. Medtronic said it’s the company’s first SCS device to offer a closed-loop feature. This feature senses each person’s unique biological signals, adjusting stimulation moment-to-moment as needed. Medtronic says that keeps therapy […]
Moon Surgical wins CE mark for Maestro surgical robot
Moon Surgical announced today that its Maestro system for surgical robotics received CE mark approval in Europe. To date, the French-American surgical robot maker said 50 patients in Europe underwent Maestro-assisted surgery. These took place in a clinical trial led by Dr. Guy-Bernard Cadière in Brussels, Belgium. The company designed Maestro to support surgeons in […]
Innovation Zed wins CE mark for insulin pen add-on device
Innovation Zed announced that it received CE mark approval in Europe for its InsulCheck Dose add-on device. Dublin, Ireland-based Innovation Zed designed the InsulCheck Dose device as a single-unit add-on device for pen injectors. It automatically captures dose value dialed, injection event time stamps and temperature. The device also captures mounting and unmounting events. Get […]
Medtronic wins CE mark for extravascular defibrillator system
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Aurora EV-ICD and Epsila EV MRI SureScan system. The Aurora EV-ICD and Epsila EV defibrillation lead treat dangerously fast heart rhythms that can lead to sudden cardiac arrest. The EV-ICD (extravascular implantable cardioverter-defibrillator) system offers the live-saving benefits of traditional ICDs. However, it […]