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 … [Read More...] about XCath Robotics receives FDA breakthrough nod for Iris system
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XCath Robotics receives FDA breakthrough nod for Iris system
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 … [Read More...] about XCath Robotics receives FDA breakthrough nod for Iris system
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 … [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, … [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 … [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 … [Read More...] about Corcym achieves first-in-human implant of TriMemo for tricuspid valve repair
![The Endurant stent graft system. [Image courtesy of Medtronic]](https://www.medicaltubingandextrusion.com/wp-content/uploads/2025/10/Endurant_Hero_woDS-1-150x150.jpg)
Medtronic says Endurant stent graft’s new CE mark could boost use for ruptured AAA
Medtronic (NYSE: MDT) has secured a CE mark for its Endurant stent graft, removing a treatment warning related to its use in ruptured abdominal aortic aneurysms (AAA). The Minnesota-run medtech giant received a similar FDA labeling change in late … [Read More...] about Medtronic says Endurant stent graft’s new CE mark could boost use for ruptured AAA
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 … [Read More...] about Boston Scientific discontinues Imager II angiographic catheter sales
