medical device guru

Cardiovascular / Cardiology

CardioQuip MCH-1000 Earns CE Mark Approval

CardioQuipTM, LLC, a medical device manufacturer focused on development and commercialization of patient temperature control and cardiovascular perfusion technology announced today it has received CE Mark approval for the MCH-1000TM Modular Cooler-Heater SeriesTM. The MCH-1000 Series of cooler-heaters is now available to European...

March 26, 2020

Cardiovascular / Cardiology

VERO Biotech Announces First Patient With COVID-19 Infection Complicating Pulmonary Hypertension Treated with GENOSYL DS, the First and Only FDA-Approved Tankless System for the Delivery of Inhaled Nitric Oxide

VERO Biotech LLC, an Atlanta, Georgia-based biotechnology company focused on saving lives, alleviating suffering, and improving the health economics of care, today announced that the first patient with COVID-19 infection complicating pulmonary hypertension has been treated with its proprietary inhaled nitric...

March 26, 2020

Cardiovascular / Cardiology

TriGUARD 3 Cerebral Embolic Protection Device Receives CE Mark for Use in Transcatheter Heart Procedures

Keystone Heart Ltd., a Venus Medtech Company, today announced European CE Mark for the TriGUARD 3™ Cerebral Embolic Protection (CEP) Device. The device is designed to minimize the risk of cerebral damage by deflecting embolic debris away from cerebral circulation during...

March 16, 2020

Cardiovascular / Cardiology

CryoLife Receives CE Mark for E-vita OPEN NEO 

CryoLife, Inc., a leading cardiac and vascular surgery company focused on aortic disease, announced today that it has received CE Mark for the E-vita Open NEO, a hybrid stent graft system for the treatment of aortic arch disease. Aortic arch disease...

March 12, 2020

Cardiovascular / Cardiology

Cardiovalve Wins FDA Breakthrough Device Designation for Transcatheter Tricuspid Valve Replacement System

Cardiovalve announced that it has received U.S. Food and Drug Administration (FDA) approval for an Early Feasibility Study (EFS) of its Transcatheter Tricuspid Valve Replacement System for a tricuspid regurgitation (TR) indication. The Cardiovalve System also has been granted ‘Breakthrough...

March 5, 2020

Cardiovascular / Cardiology

Endotronix Announces Enrollment of the First Patients in the PROACTIVE-HF Pivotal Trial 

Endotronix, a digital health and medical technology company dedicated to advancing the treatment of chronic heart failure (HF), today announced the enrollment of the first two patients in the PROACTIVE-HF pivotal trial. The trial is a pre-market investigational device exempt...

February 26, 2020

Cardiovascular / Cardiology

Cerus Endovascular Receives CE Mark Approval for its Contour Neurovascular System, Designed to Treat Intracranial Aneurysms

Cerus Endovascular Ltd., a privately-held, commercial stage medical device company, today announced that it has received CE Mark approval for its lead product, the Contour Neurovascular System™, for the treatment of intracranial aneurysms. The Contour Neurovascular System™ is a unique,...

February 18, 2020

Cardiovascular / Cardiology

FDA Grants De Novo Clearance to Bluegrass Vascular Technologies for the Surfacer Inside-Out Access Catheter System

Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today that the U.S. Food and Drug Administration (FDA) has granted a De Novo classification order for its Surfacer® Inside-Out® Access Catheter System....

February 11, 2020

Cardiovascular / Cardiology

Aria CV Receives FDA Breakthrough Designation for Its Medical Device for Treating Pulmonary Arterial Hypertension 

Aria CV, Inc., a developer of medical devices treating Pulmonary Arterial Hypertension (PAH), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the Aria CV Pulmonary Hypertension System (Aria CV PH System). The...

February 6, 2020