Renata Medical announced the first completed implantation of its Minima growth stent for young children after winning FDA approval. Newport Beach, California-based Renata picked up FDA approval for the first-of-its-kind stent last week. The company designed the stent to re-expand over the course of the child’s growth period. “Today marks the … [Read more...] about Renata Medical announces first growth stent implant following FDA approval
AngioDynamics wins CE mark for atherectomy system
AngioDynamics (Nasdaq:ANGO) announced today that it received CE mark approval for its Auryon atherectomy system. Latham, New York-based AngioDynamics designed Auryon for the treatment of peripheral artery disease (PAD). That includes critical limb ischemia (CLI) and in-stent restenosis (ISR). Auryon uses revolutionary solid-state laser … [Read more...] about AngioDynamics wins CE mark for atherectomy system
FDA grants IDE for Jupiter Endovascular’s pulmonary embolectomy system
Jupiter Endovascular announced today that the FDA approved an investigational device exemption (IDE) study for its Vertex system. The company can now conduct the SPIRARE II U.S. pivotal study for the pulmonary embolectomy system. Menlo Park, California-based Jupiter Endovascular only just came out of stealth mode, spinning out of Neptune Medical … [Read more...] about FDA grants IDE for Jupiter Endovascular’s pulmonary embolectomy system
Renata Medical wins FDA nod for first-of-its-kind stent for young children
Renata Medical today said the FDA approved its first-of-its-kind Minima growth stent tailored for neonates, infants and young children. Newport Beach, California-based Renata designed the stent to re-expand over the course of the child’s growth period. The company says its approval marks a “groundbreaking advancement” in care for young children … [Read more...] about Renata Medical wins FDA nod for first-of-its-kind stent for young children
CereVasc wins FDA breakthrough nod for eShunt system
CereVasc announced today that it received FDA breakthrough device designation for its eShunt system for treating normal pressure hydrocephalus (NPH). The company said data generated during pilot clinical studies of the device supported the breakthrough device designation. This designation enables priority review and enhanced communication with … [Read more...] about CereVasc wins FDA breakthrough nod for eShunt system
J&J’s Biosense Webster completes enrollment in pulsed field ablation trial, earns coverage win in Japan
Johnson & Johnson MedTech’s Biosense Webster announced today that it completed enrollment in its Omny-IRE pulsed field ablation (PFA) trial. The prospective, multi-center, non-randomized trial enrolled 188 patients in Europe and Canada. It evaluates the safety and effectiveness of the company's Omnypulse platform. The J&J unit designed … [Read more...] about J&J’s Biosense Webster completes enrollment in pulsed field ablation trial, earns coverage win in Japan
Obvius Robotics earns FDA breakthrough nod for central venous catheterization access system
Obvius Robotics announced today that the FDA granted breakthrough device designation for its Certa access system for central venous catheterization (CVC). CVC procedures require access to one of the great veins (internal jugular, subclavian, or femoral) to place a multi-lumen catheter for rapid replacement of blood volume, administration of … [Read more...] about Obvius Robotics earns FDA breakthrough nod for central venous catheterization access system
Karl Storz, Fujifilm partner on next-gen endoscopy tech
Karl Storz U.S. and Fujifilm Healthcare Americas today announced a partnership to provide comprehensive solutions for endoscopists and surgeons. The companies plan to jointly market Fujifilm's flexible gastrointestinal (GI) endoscopes along with Karl Storz's OR integration solutions. Together, they aim to enhance the experience for surgical ORs, … [Read more...] about Karl Storz, Fujifilm partner on next-gen endoscopy tech
FDA clears Siemens Healthineers’ AI-powered cardiovascular ultrasound and catheter
Siemens Healthineers announced today that it received FDA clearance for its Acuson Origin ultrasound system and AcuNav Lumos 4D ICE catheter. Acuson Origin, a new, dedicated cardiovascular ultrasound, includes AI-powered features. It can help physicians perform cardiac procedures more efficiently in the areas of diagnostics, structural heart … [Read more...] about FDA clears Siemens Healthineers’ AI-powered cardiovascular ultrasound and catheter
Penumbra announces $200M share repurchase program
Penumbra (NYSE:PEN) announced today that its board of directors approved a share repurchase authorization of up to $200 million. Alameda, California-based Penumbra said in a news release that its board approved the repurchase on Aug. 5. It allows the company to repurchase its common stock from time to time at such prices as it deems appropriate. … [Read more...] about Penumbra announces $200M share repurchase program
