Medical Tubing and Extrusion

Medical tubing and extrusion technologies

Regulatory

XCath Robotics receives FDA breakthrough nod for Iris system

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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

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

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

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

Medtronic wins expanded indication in Europe for Affera to treat VT

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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 

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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 

enVVeno Medical wins FDA IDE for non-surgical transcatheter replacement venous valve

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enVVeno Medical (Nasdaq:NVNO) announced today that it received FDA investigational device exemption (IDE) for its enVVe system. The IDE allows Irvine, California–based enVVeno  (formerly Hancock Jaffe) to begin the TAVVE pivotal trial for the system. It represents a first-in-class minimally invasive, non-surgical replacement venous valve for … [Read more...] about enVVeno Medical wins FDA IDE for non-surgical transcatheter replacement venous valve