Valgen earns CE mark for mitral valve repair system
June 28, 2026
Valgen Medtech announced today that it received CE mark approval for its DragonFly transcathteter mitral repair system.
Valgen Medtech announced today that it received CE mark approval for its DragonFly transcathteter mitral repair system.
First Read aims to address interpretation bottlenecks by producing preliminary, high-quality report drafts.
This authorisation will expand the B-Right AI platform’s use to Europe, as BrightHeart continues to roll the technology out across the US.
Cyclana Bio, a biotechnology company pioneering tissue-level approaches to women’s health, has announced it has received Health Research Authority (HRA) and Research Ethics Committee (REC) approval for its 500-patient clinical observational study, PEMP (Predicting Endometriosis Mechanisms and Populations).
Spotlight Medical, a Paris-based oncology diagnostics company, has announced that myStage Dx has received CE marking under the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746).
Draeger has received FDA 510(k) clearance to market the latest software update for its Evita V800 ventilator. The version 3.10 software release introduces additional features designed to enhance mechanical ventilation for patients with pulmonary conditions, including acute respiratory distress syndrome (ARDS).
The power-injectable implantable port system is designed to support long-term vascular access in adult and paediatric patients.
AorticLab announced today that its FLOWer device received CE mark approval for extended use in transcatheter cardiovascular procedures.
LEM Surgical announced today that the FDA granted a new 510(k) clearance for its Dynamis robotic surgical system.
Masimo, a Danaher (NYSE:DHR) company, today announced FDA clearance for an opioid-induced respiratory depression (OIRD) detection platform.