medical device guru

Cardiovascular / Cardiology

Clinical Study Utilizes the myTAIHEART Test to Monitor Cell-Free DNA Levels, 2-10 Days Post-Transplantation, in Pediatric Heart Transplant Recipients 

TAI Diagnostics, Inc., focused on developing innovative diagnostic tests for monitoring the health of transplanted organs, today announced the publication of “Early Changes in Cell-Free DNA Levels in Newly Transplanted Heart Transplant Patients” in the December 11th open access version of Pediatric Transplantation, the...

December 18, 2019

Cardiovascular / Cardiology

First Patient Enrolls in New Trial for Abiomed’s Impella Looks for Heart Failure Reduction

Abiomed (NASDAQ: ABMD) announces initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial (RCT), which will explore whether unloading the heart’s left ventricle for 30 minutes with an Impella heart pump prior to opening blocked arteries will reduce infarct...

December 16, 2019

Cardiovascular / Cardiology

Doctors ‘reanimate’ heart for first-of-its-kind transplant in the US

TransMedics announced today that the doctors at two hospitals performed the first U.S. heart transplants using donor hearts that were resuscitated using the company’s organ care system (OCS). The transplants from donation after circulatory death (DCD) took place at Duke University...

December 5, 2019

Cardiovascular / Cardiology

ALung Technologies Announces Continued Progress Towards Completion of Two Landmark Pivotal Trials 

ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced the recent achievement of two significant clinical trial milestones, enrollment of 60 plus patients in its U.S. based VENT-AVOID...

December 3, 2019

Cardiovascular / Cardiology

BioVentrix Gains FDA Breakthrough Device Designation for their Revivent TC Transcatheter Ventricular Enhancement System

BioVentrix, Inc., a privately-held company with a first-in-class, transcatheter-based structural heart device to treat heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation status for its Revivent TC™ Transcatheter Ventricular...

November 20, 2019

Cardiovascular / Cardiology

Centerline Biomedical Announces First-in-Human Use of IOPS™ Intra-Operative Positioning System

Centerline Biomedical, Inc., a spinout company from Cleveland Clinic, announced the successful first human clinical use of its groundbreaking IOPS™ technology. IOPS, the Intra-Operative Positioning System, provides doctors performing minimally-invasive vascular repairs with an intuitive, interactive color 3D display. IOPS, the...

November 18, 2019

Cardiovascular / Cardiology

Edwards Lifesciences gets approval for SAPIEN 3 TAVI valve in Europe

Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has received CE Mark to expand use of the Edwards SAPIEN 3 transcatheter heart valve for the...

November 14, 2019

Cardiovascular / Cardiology

Saranas Announces First Commercial Case With Early Bird® Bleed Monitoring System in the U.S. 

Saranas, Inc. announced completion of the first U.S. commercial case using the Early Bird® Bleed Monitoring System for real-time detection and monitoring of endovascular bleed complications. Dr. Robert Kipperman, co-director of the Structural Heart Disease Program at Morristown Medical Center, and...

November 7, 2019

Cardiovascular / Cardiology

Anaconda Biomed Announces First-in-Human Study of Next-Generation Thrombectomy System 

Anaconda Biomed, a medical technology company developing a next-generation thrombectomy system for the treatment of ischemic stroke, has announced the completion of initial patient cases in a first-in-human study at Hospital Vall d’Hebron in Barcelona. This 125-patient, prospective, multi-center study will assess...

November 5, 2019