Oct. 14, 2025 — Nurea has announced that its PRAEVAorta 2 software has received FDA 510(k) clearance, enabling entry into the U.S. market. PRAEVAorta 2 provides vascular physicians with the most advanced automated measurement tools for aortic diameters on contrasted and non-contrasted CT scans, supporting diagnosis and patient follow-up in aortic aneurysm management.

Oct. 13, 2025 — Medtronic plc recently announced it has received U.S. Food and Drug Administration (FDA) labeling approval1 for the Medtronic Endurant stent graft system, by adding ruptured abdominal aortic aneurysm (rAAA) clinical evidence and removing the rAAA treatment warning.

This FDA labeling approval makes Medtronic the first and only company to remove the rAAA warning from its stent graft system Instructions for Use (IFU), aligning innovation with real-world practices and training to empower physicians to act confidently in emergency cases.

Oct. 10, 2025  — Johnson & Johnson MedTech, in collaboration with the Heart Rhythm Clinical and Research Solutions, LLC., has introduced the Collaborative Outcomes Registry for Evidence in Ventricular Arrhythmias (CORE-VA) during the International Symposium on Ventricular Arrhythmias in Philadelphia, Pennsylvania. The prospective, multicenter registry is designed to capture contemporary practice patterns in ventricular arrhythmia, including ventricular tachycardia (VT), ablation and generate high-quality real-world evidence.

Oct. 10, 2025 — Berlin Heals Holding AG, a clinical-stage medical device company focused on revolutionizing the care of heart failure with a first of its kind durable treatment, announced it has completed enrollment in the First-In-Human (FIH) CMIC-III study to evaluate the safety of a new less invasive approach to implanting the Cardiac Microcurrent (CMIC) device. Topline data are expected in 2026 and will be submitted for presentation at a major Cardiology Congress.

Oct. 8, 2025 — Viz.ai recently launched  Viz ACS, a new solution in the Viz Cardio Suite. Designed to unite the acute coronary syndrome (ACS) care team on a single platform, Viz ACS provides Emergency Department (ED) physicians and cardiologists with the same high-quality ECGs and patient data in real time. This streamlined workflow can help improve communication, speeds treatment, and reduces unnecessary cath lab activations.

Oct. 7, 2025 — RSNA Ventures, a mission-aligned subsidiary of Radiological Society of North America (RSNA), has announced a strategic partnership with Rad AI, the leader in generative AI for healthcare, to advance innovation in radiology and imaging technologies.

Oct. 7, 2025 — Cagent Vascular has announced the commercial launch of the Serranator PTA Serration Balloon Catheter in 7.0 mm and 8.0 mm diameters. This expansion brings the proven benefits of serration technology to larger vessels, including the iliac, SFA and other challenging peripheral anatomies.

Oct. 7, 2025 — Medtronic has announced the full distribution of the Neuroguard IEP System (Neuroguard) after a successful limited market distribution. This milestone follows the announcement earlier this year of its exclusive U.S. distribution agreement with Raleigh, North Carolina-based Contego Medical.

Oct. 7, 2025 — Nobles Medical Technology II, a provider of  cardiovascular closure solutions, has announced that the U.S. Food and Drug Administration (FDA) has granted approval to restart its NobleStitch clinical trial, marking an important milestone in the development of the first device-free, suture-mediated system for closing patent formaen ovale (PFO) for reduction of recurrent cryptogenic stroke.

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