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Cardiovascular / Cardiology

Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch® Ventricular Restoration System

Ancora Heart, Inc., a company developing a novel device-based therapy to address heart failure, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch® Ventricular Restoration System. Currently being evaluated in the CORCINCH-HF pivotal...

July 13, 2022

Cardiovascular / Cardiology

Okami Medical Announces FDA 510(k) Clearance of the LOBO-7 and LOBO-9 Vascular Occluders to Address a Wide Range of Peripheral Embolization Cases

Okami Medical Inc., a medical device company focused on developing innovative solutions that address key unmet clinical needs in peripheral vascular intervention, announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the LOBO-7 and LOBO-9 Vascular Occluders, the latest...

June 17, 2022

Cardiovascular / Cardiology

Cardio Flow, Inc., Announces FDA Clearance for FreedomFlow® Peripheral Guidewire, and their First Commercial Case Completed in U.S.

Cardio Flow, Inc., a medical device company and developer of minimally invasive peripheral vascular devices to treat peripheral artery disease (PAD), announced it recently received U.S. Food and Drug Administration (FDA) clearance for the company’s FreedomFlow® Peripheral Guidewire. The FreedomFlow...

June 7, 2022

Cardiovascular / Cardiology

Acutus Medical Announces Agreements to Fund Strategic Growth Priorities

Acutus Medical, Inc., an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, announced a commitment letter from Deerfield Management Company (“Deerfield”), to refinance its existing debt with a new longer-term credit facility, and in...

April 29, 2022

Cardiovascular / Cardiology

Artio Medical Receives FDA Clearance for Solus Gold™ Embolization Device

Artio Medical, Inc., a medical device company developing innovative products for the peripheral vascular, neurovascular, and cardiology markets, announced it received US Food and Drug Administration (FDA) clearance for its Solus Gold Embolization Device, a next-generation product for peripheral vascular occlusion....

April 4, 2022

Cardiovascular / Cardiology

TransMedics Receives FDA Clearance of OCS Lung Solution for Cold Preservation of Lungs

TransMedics Group, Inc. (“TransMedics”), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its OCS™ Lung Solution for use...

August 1, 2021

Cardiovascular / Cardiology

CARMAT Announces the First Human Implant of its Total Artificial Heart in the United States

CARMAT, the designer and developer of the total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, announces the first implantation of its bioprosthetic artificial heart, Aeson,...

July 18, 2021

Cardiovascular / Cardiology

AliveCor Purchases CardioLabs

AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology and services, today announced that it has acquired the independent diagnostic testing facility (IDTF) CardioLabs, a leading monitoring and cardiac diagnostic service provider. The acquisition is a cornerstone of AliveCor’s...

June 6, 2021

Cardiovascular / Cardiology

TricValve Transcatheter Bicaval Valves System Receives CE Mark

OrbusNeich Medical Company Ltd. and P&F Products & Features, under the joint partnership OrbusNeich P&F, today announced that the TricValve® Transcatheter Bicaval Valves System has received CE mark approval. The TricValve Transcatheter Bicaval Valve (bioprosthesis) is developed for the treatment...

May 23, 2021