VARIPULSE™ Pulse Field Ablation (PFA) Platform Gains CE Mark

Biosense Webster, Inc., has announced European CE mark approval of the VARIPULSE™ Platform. The approval covers the treatment of symptomatic drug refractory … continue reading “VARIPULSE™ Pulse Field Ablation (PFA) Platform Gains CE Mark”

First Patient Receives Fully Implanted Acclaim® Cochlear Implant in Envoy Medical Early Feasibility Study

Envoy Medical® Corporation tells us the first patient has been enrolled and implanted in the Acclaim® Cochlear Implant early feasibility … continue reading “First Patient Receives Fully Implanted Acclaim® Cochlear Implant in Envoy Medical Early Feasibility Study”

First-in-Human Trial will Assess the Safety and Effectiveness of Coherent Sine Wave Electroporation in Patients with Atrial Fibrillation

Swiss company Argá Medtech has begun enrollment in a First-in-Human Clinical Trial of its CSE Ablation System in the treatment … continue reading “First-in-Human Trial will Assess the Safety and Effectiveness of Coherent Sine Wave Electroporation in Patients with Atrial Fibrillation”

First Limus Drug-eluting Balloon for US as SELUTION SLR™ Gets FDA IDE Approval

MedAlliance’s SELUTION SLR™ drug-eluting balloon (DEB) has received FDA Investigational Device Exemption (IDE) approval, making it the first limus DEB … continue reading “First Limus Drug-eluting Balloon for US as SELUTION SLR™ Gets FDA IDE Approval”