XCath Robotics has FDA Breakthrough Device Designation for its in-development Iris surgical robotic system for mechanical thrombectomy to treat acute ischemic stroke. Houston-based XCath says the designation provides increased opportunities to interact with FDA experts and receive support during the regulatory development and review process for … [Read more...] about XCath Robotics receives FDA breakthrough nod for Iris system
Technologies & Devices
Luma Vision wins expanded FDA nod for its cardiac procedure software
Luma Vision has won FDA clearance to expand the capabilities of its Verafeye cardiac ablation procedure intelligence platform. The privately held, Dublin, Ireland–based medtech plans to launch commercially in early 2027. The news comes about six months after the company said it was expanding its clinical programs after submitting to the … [Read more...] about Luma Vision wins expanded FDA nod for its cardiac procedure software
Edwards Lifesciences, Medtronic score CMS win over TAVR
Edwards Lifesciences (NYSE: EW) and Medtronic (NYSE: MDT) are among the medtech companies praising CMS’s decision to expand Medicare coverage for TAVR to people with asymptomatic severe aortic stenosis. The finalized national coverage decision, published yesterday evening, also removes the evidence development (CED) requirement for symptomatic … [Read more...] about Edwards Lifesciences, Medtronic score CMS win over TAVR
Abbott earns FDA approval for new dual-energy ablation catheter
Abbott (NYSE: ABT) earned FDA approval for its new dual-energy catheter, TactiFlex Duo sensor-enabled ablation catheter. TactiFlex Duo joins Johnson & Johnson MedTech’s ThermoCool SmartTouch SF and Medtronic's Affera Sphere-9 catheter in the U.S. dual-energy ablation catheter market. Medtronic won its Sphere-9 approval in 2024, and J&J … [Read more...] about Abbott earns FDA approval for new dual-energy ablation catheter
Corcym achieves first-in-human implant of TriMemo for tricuspid valve repair
Corcym today announced that Cleveland Clinic doctors performed the first-in-human implantation of TriMemo, a semi-rigid ring designed to repair the tricuspid valve. The ring comprises three layers: a carbon film coating over the oval silicone sheath, which together guard the laser-cut nitinol cell structure. Nitinol, a superelastic … [Read more...] about Corcym achieves first-in-human implant of TriMemo for tricuspid valve repair
Boston Scientific discontinues Imager II angiographic catheter sales
Boston Scientific recalled and discontinued all Imager II angiographic catheters due to a manufacturing issue, according to an FDA early alert. Imager II angiographic catheters are diagnostic intravascular catheters used to capture images of the patient’s peripheral vasculature. Boston Scientific determined the catheters were “manufactured … [Read more...] about Boston Scientific discontinues Imager II angiographic catheter sales
FastWave Medical earns FDA IDE approval for next-gen IVL system
FastWave Medical earned FDA investigational device exemption (IDE) approval for its next-generation intravascular lithotripsy (IVL) technology, the company announced today. The approval clears the company to begin a U.S. pivotal trial of its Artero electric IVL system designed to treat peripheral artery disease. "Reaching IDE approval takes a … [Read more...] about FastWave Medical earns FDA IDE approval for next-gen IVL system
Medtronic wins expanded indication in Europe for Affera to treat VT
Medtronic (NYSE: MDT) has won an expanded CE mark indication for its Affera mapping and ablation system with Sphere-9 catheter to treat ventricular arrhythmias. The expanded indication, announced today, includes ventricular tachycardia (VT) and premature ventricular complexes (PVCs). According to Medtronic, the Sphere-9 catheter is the first … [Read more...] about Medtronic wins expanded indication in Europe for Affera to treat VT
Galaxy Therapeutics’ SEAL embolization system gets CE mark
By Julia Rock-Torcivia Galaxy Therapeutics, a privately held medical device company focused on the treatment of intracranial aneurysms, today announced that it has received CE mark for its SEAL Embolization System. The CE mark follows successful assessment by Notified Body DQS Medizinprodukte GmbH. SEAL (which stands for Saccular … [Read more...] about Galaxy Therapeutics’ SEAL embolization system gets CE mark
Adagio treats first patient with next-gen low-temp ablation system
Adagio Medical (Nasdaq:ADGM) today announced the successful treatment of the first patient with its next-generation vCLAS technology. The treatment took place under the FDA's Expanded Access authorization. It utilized the company's Ultra Ultra-Low Temperature Ablation (ULTA) system. Laguna Hills, California-based Adagio said the patient … [Read more...] about Adagio treats first patient with next-gen low-temp ablation system
