Limited Release of BioCardia AVANCE™ Steerable CV Catheter Introducer

Following its recent FDA clearance, BioCardia, Inc. has confirmed the U.S. commercial availability of the AVANCE™ Bi-Directional Steerable Introducer Sheath for introducing … continue reading “Limited Release of BioCardia AVANCE™ Steerable CV Catheter Introducer”

Medtronic Submits InterStim™ Micro Neurostimulator and SureScan™ MRI Leads to FDA

Medtronic plc tells us it has filed a pre-market approval (PMA) supplement with the U.S. FDA for approval of its … continue reading “Medtronic Submits InterStim™ Micro Neurostimulator and SureScan™ MRI Leads to FDA”

FDA Breakthrough Device Designation for SoniVie’s TIVUS Pulmonary Arterial Hypertension System

Pulmonary Arterial Hypertension (PAH) treatment specialist SoniVie, has been granted Breakthrough Device Designation from the U.S. FDA for the Therapeutic … continue reading “FDA Breakthrough Device Designation for SoniVie’s TIVUS Pulmonary Arterial Hypertension System”

Abbott Launches World’s First Pivotal Trial to Test Leaky Tricuspid Heart Valve Repair System

Abbott has announced the launch of the TRILUMINATE Pivotal trial to evaluate the safety and effectiveness of its TriClip transcatheter … continue reading “Abbott Launches World’s First Pivotal Trial to Test Leaky Tricuspid Heart Valve Repair System”

CE Mark for Orchestra BioMed BackBeat Cardiac Neuromodulation Therapy™ for Hypertension

Orchestra BioMed™, Inc., tells us it has received CE Mark approval for its Moderato® implantable pulse generator system that delivers BackBeat … continue reading “CE Mark for Orchestra BioMed BackBeat Cardiac Neuromodulation Therapy™ for Hypertension”