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
Latest News on Medical Tubing & Extrusion
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
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
FDA warns on percutaneous catheter issue from Boston Scientific
The FDA today issued an early notice after Boston Scientific (NYSE:BSX) recommended the removal of certain percutaneous catheter systems. In a letter dated July 9, 2026, Boston Scientific told customers to identify affected EnRoute transcarotid neuroprotection system (NPS) and EnRoute NPS Plus products and cease use and distribution. Customers … [Read more...] about FDA warns on percutaneous catheter issue from Boston Scientific
Boston Scientific enrolls first patient in FARADIGM IDE trial for Faraflex PFA system
A Boston Scientific (NYSE:BSX) executive said today that the company enrolled the first patients in a new pulsed field ablation (PFA) trial. Nick Spadea-Anello, Boston Scientific EVP and president of Electrophysiology, shared the news of the initial enrollments on LinkedIn. Dr. Andrea Natale and the Texas Cardiac Arrhythmia Research team at St. … [Read more...] about Boston Scientific enrolls first patient in FARADIGM IDE trial for Faraflex PFA system
Baxter warns on intravascular administration sets
The FDA issued an early alert after Baxter (NYSE:BAX) recommended the removal of certain Duo-Vent intravascular administration sets. Baxter sent all affected customers a letter on June 30, telling them to immediately identify, quarantine and return affected lots. The communication affects lots DR26C27062, DR26D14031 and DR26E13055 of the … [Read more...] about Baxter warns on intravascular administration sets
