Johnson & Johnson's Biosense Webster today announced the first cases with its investigational Omnypulse catheter as part of the Omny-IRE clinical trial. The Omnypulse platform features the Omnypulse catheter and the Trupulse generator. Omny-IRE looks at the platform for mapping and treatment of symptomatic paroxysmal AFib during standard … [Read more...] about Biosense Webster begins Omnypulse pulsed-field ablation trial
CereVasc wins FDA IDE to expand eShunt trial
CereVasc announced today that the FDA approved an investigational device exemption (IDE) supplement for a study of its eShunt system. The FDA permitted the expansion of the study for patients with normal pressure hydrocephalus (NPH) to additional participants and sites. The company initiated the pilot study of its eShunt system under IDE in … [Read more...] about CereVasc wins FDA IDE to expand eShunt trial
Farapulse founder’s Field Medical raises $14M for next-gen cardiac ablation tech
Field Medical announced today that it closed an oversubscribed seed round with investments reaching $14 million. Private investors led the funding for the Cardiff-by-the-Sea, California-based cardiac ablation technology developer. Multiple strategic investors also joined the round. The company earmarked the funds to support … [Read more...] about Farapulse founder’s Field Medical raises $14M for next-gen cardiac ablation tech
FDA approves LimFlow chronic limb-threatening ischemia treatment
LimFlow announced today that the FDA approved its LimFlow System for treating chronic limb-threatening ischemia (CLTI). Approval enables the treatment to help those with CLTI with no other suitable endovascular or surgical treatment options available. These patients can face major amputation as a result of their condition. France-based … [Read more...] about FDA approves LimFlow chronic limb-threatening ischemia treatment
Gradient Denervation raises $15M Series A for catheter tech
Gradient Denervation Technologies announced that it closed a $15 million (€14 million) Series A financing round. Paris-based Gradient develops a catheter-based solution for treating pulmonary hypertension. It expects the financing to support the ongoing clinical development and evaluation of the ultrasound-based device. Asabys Partners led … [Read more...] about Gradient Denervation raises $15M Series A for catheter tech
HighLife unveils new large annular valve for mitral regurgitation clinical trials
HighLife SAS announced this week that it introduced a new valve size in its clinical trials for treating mitral regurgitation (MR) in larger anatomies. Paris-based HighLife’s latest trans-septal mitral valve replacement (TSMVR) is a large annulus valve (LAV). The company designed it to fit within its existing delivery catheter and to accommodate … [Read more...] about HighLife unveils new large annular valve for mitral regurgitation clinical trials
Rapid Medical wins Chinese approval for adjustable thrombectomy device
Rapid Medical announced that it received Chinese approval for its Tigertriever revascularization device for blood clot removal. Yokneam, Israel-based Rapid Medical designed Tigertriever to remove thrombus from delicate brain blood vessels during an ischemic stroke. With National Medical Product Administration (NMPA) approval, it becomes the … [Read more...] about Rapid Medical wins Chinese approval for adjustable thrombectomy device
GLP-1 startup i2o looks to revive diabetes drug-eluting implant from Intarcia
i2o Therapeutics says it acquired the diabetes-treating assets of one-time medtech unicorn Intarcia Therapeutics. The Boston-based company acquired and integrated Intarcia’s proprietary assets and made a big personnel move. With CEO Ravi Srinivasan moving onto other opportunities, i2o named Kurt Graves as chair, president and CEO. Graves … [Read more...] about GLP-1 startup i2o looks to revive diabetes drug-eluting implant from Intarcia
FDA approves next-gen Watchman FLX Pro from Boston Scientific
A string of positive news continues for Boston Scientific (NYSE: BSX), which this week announced FDA approval for its next-generation Watchman FLX. Last week, the company reported positive data for its Farapulse system, which led to a favorable reaction from analysts and the market. Just the week before, Boston Scientific received expanded FDA … [Read more...] about FDA approves next-gen Watchman FLX Pro from Boston Scientific
FDA fast-tracks aneurysm stabilization system from Nectero Medical
Nectero Medical announced today that the FDA granted fast track designation to its endovascular aneurysm stabilization treatment (EAST) system. Tempe, Arizona-based Nectero designed its EAST system to treat patients with abdominal aortic aneurysm (AAA). These AAAs have a maximum diameter of 3.5 cm to 5 cm. The company plans to initiate a … [Read more...] about FDA fast-tracks aneurysm stabilization system from Nectero Medical
