Elixir Medical announced today that it received CE mark for its LithiX hertz contact (HC) intravascular lithotripsy (IVL) system. The Milpitas, California–based company kicked off its commercial launch for the IVL system in Europe following receipt of CE mark. Dr. Stefano Galli (Centro Cardiologico Monzino in Milan), Dr. Eric Van Belle (Lille … [Read more...] about Elixir Medical launches IVL system in Europe
CE Mark
Boston Scientific wins CE mark for Farapulse Nav mapping tech
Boston Scientific announced today that it received CE mark for its navigation-enabled Farawave Nav ablation catheter and Faraview software. Farawave Nav and the Faraview software make up part of the company’s Farapulse pulsed field ablation (PFA) system. Boston Scientific initially won FDA approval for Farapulse in January 2024. In doing so, it … [Read more...] about Boston Scientific wins CE mark for Farapulse Nav mapping tech
Medtronic wins CE mark for jugular dual lumen catheter for young children
A Medtronic official said today on LinkedIn that the company won CE mark for its Crescent RA jugular dual lumen catheter. Giuseppe Savoja, the medtech giant's senior business director for Western Europe, posted the announcement on LinkedIn: "Exciting times! I'm proud and thrilled to announce that the Medtronic Crescent RA jugular dual lumen … [Read more...] about Medtronic wins CE mark for jugular dual lumen catheter for young children
Stereotaxis Magic ablation catheter is now CE mark approved
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 … [Read more...] about Stereotaxis Magic ablation catheter is now CE mark approved
Johnson & Johnson MedTech wins CE mark for dual-energy catheter
Johnson & Johnson MedTech [WtwhTicker symbol="JNJ"](NYSE: JNJ)[/WtwhTicker] announced today that it received CE mark approval for its dual-energy ThermoCool SmartTouch SF catheter. The irrigated, contact-force sensing catheter features alongside the TruPulse generator. Both offer full integration with the Carto 3 electro-anatomical mapping … [Read more...] about Johnson & Johnson MedTech wins CE mark for dual-energy catheter
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 … [Read more...] about Medtronic gets CE mark for Harmony transcatheter pulmonary valve
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
Endostart wins CE mark to bring magnetic balloon tech to enteroscopy
Endostart announced today that it received CE mark approval for the expanded use of its flagship Endorail product. Certaldo, Italy-based Endostart designed Endorail to provide efficiency and safety in endoscopic procedures. The technology utilizes a magnetic balloon system to enhance control of the endoscope in both the small and large bowel. It … [Read more...] about Endostart wins CE mark to bring magnetic balloon tech to enteroscopy
Penumbra wins CE mark for computer-assisted thrombectomy tech
Penumbra (NYSE:PEN) announced today that it received CE mark approval for its computer-assisted vacuum thrombectomy (CAVT) technologies. The Lightning Flash 2.0 and Lightning Bolt 7 offerings from the Alameda, California-based company both picked up European approval. Penumbra said approval makes its Lightning products the only CAVT systems … [Read more...] about Penumbra wins CE mark for computer-assisted thrombectomy tech
AngioDynamics wins CE Mark for AlphaVac F18
AngioDynamics announced this week that it received CE Mark approval for its AlphaVac F18 system, which treats pulmonary embolism and removes thrombi and emboli. AlphaVac F18 is an emergent first-line device the company designed for the non-surgical removal of thromboemboli from the pulmonary arteries and for the treatment of pulmonary … [Read more...] about AngioDynamics wins CE Mark for AlphaVac F18
