CryoLife Receives CE Mark for E-vita OPEN NEO 

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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 includes both aortic aneurysms and aortic dissections, which occur suddenly and usually without warning. Approximately…

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

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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 Device Designation’ status by the FDA. Cardiovalve is the first privately held company to have…

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

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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 (IDE) study evaluating the safety and efficacy of the Cordella™ Pulmonary Artery (PA) Pressure Sensor…

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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, fine mesh braid that is deployed across the neck of the aneurysm sac and provides…

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

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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. The Surfacer System is intended to obtain central venous access to facilitate catheter insertion into…

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

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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 Breakthrough Devices Program (BDP) is intended to expedite the FDA review and approval of designated…

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Imricor’s MRI-Compatible Ablation Catheters Cleared in Europe for Cardiac Arrhythmia Treatment

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Imricor Medical Systems, Inc. (ASX:IMR) today announces that it has received CE mark approval for its Vision-MR Ablation Catheter and Vision-MR Dispersive Electrode. This follows earlier CE mark approval for Imricor to place its Advantage-MR EP Recorder/Stimulator System on the market in Europe. Imricor is the first and only company to offer cardiac ablation devices for…

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FDA Clears Eko’s AFib and Heart Murmur Detection Algorithms, Making It the First AI-Powered Stethoscope to Screen for Serious Heart Conditions

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Eko, a digital health company applying artificial intelligence (AI) in the fight against heart disease, announced today that the U.S. Food and Drug Administration has cleared a suite of algorithms that, when combined with Eko’s digital stethoscopes, will enable healthcare providers in the U.S. to more accurately screen for heart conditions during routine physical exams.…

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VivaLNK Announces World’s First FDA Cleared Wearable ECG Sensor Platform

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VivaLNK, a leading provider of connected healthcare solutions, today announces it received FDA clearance for its Continuous ECG Platform. Consisting of reusable wearable ECG sensors and associated software development kit (SDK), the sensor platform gives developers and providers direct control over data, and represents the first of its kind to receive FDA clearance. One of…

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BioCardia Announces FDA Clearance for Morph DNA Catheter to Guide Cell Delivery into Heart Tissue

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BioCardia (BCDA)®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Morph® DNA deflectable guide catheter used to guide the Helix™ Biotherapeutic Delivery System during CardiAMP™ cell therapy delivery in the heart. The Morph DNA deflectable…

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