Tag Archive for: Medtech

Amber Implants Secures FDA 510(k) Clearance for VCFix® Spinal System: A Next-Generation Solution for Vertebral Compression Fractures

FDA clearance confirms robust safety and performance of VCFix® Spinal System, a breakthrough treatment for vertebral compression fractures US commercial pilot launch planned for early 2026, followed by broader physician availability from summer 2026 One-year trial data show significant clinical improvements, supporting VCFix® Spinal System as a potential new standard of care The Hague, The […]

ViCentra Raises $85M to Scale Manufacturing and Accelerate Market Penetration of Kaleido Insulin Patch Pump

Led by new investor Innovation Industries, with matching contributions from existing investors, Partners in Equity and Invest-NL, the $85M round also drew support from EQT Life Sciences and Health Innovations, demonstrating strong confidence in ViCentra’s next phase of growth Fresh capital fuels scale-up, regulatory pathway, and commercialization of Kaleido 2, the world’s smallest, lightest, and […]

Xeltis announces positive data for Xabg, its coronary artery bypass conduit, in EU clinical trial

Preliminary clinical data from Xabg, Xeltis’ coronary artery bypass conduit (CABG), demonstrating positive safety and patency  In an earlier, separate trial, Xabg recently demonstrated patency with excellent flow in a 24-month trial – the first time ever this duration has been achieved Supports potential of Xabg to transform CABG surgery landscape and eliminate need for […]

Neuraxpharm and Dizlin Pharmaceuticals Announce Global Strategic Co-Development Agreement Bringing Next-Generation Drug-Device Therapy to Patients with Advanced Parkinson’s Disease

Infudopa SubC® is a user-friendly and minimally invasive alternative enabling flexible dosing and thereby empowering patients with greater independence Düsseldorf, Germany and Gothenburg, Sweden – 8 July 2025 – Neuraxpharm Group (“Neuraxpharm”), a leading European specialty pharmaceutical company dedicated to central nervous system (CNS) disorders, and Dizlin Pharmaceuticals AB (“Dizlin”), a Swedish R&D company focused […]