Medical Tubing and Extrusion

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Luma Vision wins expanded FDA nod for its cardiac procedure software

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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

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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

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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

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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

Medtronic says Endurant stent graft’s new CE mark could boost use for ruptured AAA

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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 2025. A ruptured AAA occurs when the main artery in the abdomen bursts, causing severe internal … [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

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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

MicroPort covered stent system receives special review in China

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MicroPort Coronary announced that its FireShield coronary covered stent system will undergo the National Medical Products Administration (NMPA) special review procedures in China. The special review procedures aim to accelerate review for innovative medical devices that meet criteria for domestic originality, technical novelty and clinical … [Read more...] about MicroPort covered stent system receives special review in China

Jupiter Endovascular appoints Catalin Toma as chief medical officer 

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Jupiter Endovascular, an endovascular interventions developer, has appointed interventional cardiologist Dr. Catalin Toma as chief medical officer, a new role for the company. Toma brings clinical and research experience across the structural heart and interventional landscape to his new role with Jupiter Endovascular, the company said … [Read more...] about Jupiter Endovascular appoints Catalin Toma as chief medical officer 

FastWave Medical earns FDA IDE approval for next-gen IVL system

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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

FDA issues Class I recall for Hamilton Medical ventilator components

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The FDA issued a Class 1 recall for certain Hamilton Medical coaxial breathing circuit sets after reports of four serious injuries. Hamilton Medical said certain lots of coaxial breathing circuit sets used with its Hamilton-C1, Hamilton T-1 and Hamilton-MR-1 ventilators are preassembled with an expiratory valve set that doesn’t perform as … [Read more...] about FDA issues Class I recall for Hamilton Medical ventilator components