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
Catheters
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
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
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
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
enVVeno Medical wins FDA IDE for non-surgical transcatheter replacement venous valve
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
Total Flow Medical earns FDA nod for femoral arterial cannula for cardiopulmonary bypass
Total Flow Medical announced today that it received FDA 510(k) clearance for its TFA femoral arterial cannula device. Vancouver-based Total Flow Medical's TFA cannula received clearance for extracorporeal circulation during cardiopulmonary bypass procedures for up to six hours. Femoral arterial cannulation, a commonly used technique for … [Read more...] about Total Flow Medical earns FDA nod for femoral arterial cannula for cardiopulmonary bypass
Xeltis raises $23.3M to bring vascular access device to US
Xeltis announced today that it raised $23.3 million (€20.5m) in funding from both new and existing shareholders. Eindhoven, the Netherlands-based company said that, combined with $55 million raised at the end of 2025, the latest funding demonstrates investor confidence in its strategy and strengthens its ability to execute on clinical, … [Read more...] about Xeltis raises $23.3M to bring vascular access device to US
