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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
Cardiovascular / Cardiology
Rapid Medical Receives FDA Clearance for the First Adjustable Stent Retriever for Use in Ischemic Stroke Treatment
Rapid Medical, developer of responsive, adjustable neurovascular devices, announces the FDA clearance of its TIGERTRIEVER™ revascularization device for use in the treatment of ischemic stroke. TIGERTRIEVER is the first stent retriever to offer intelligent control, enabling neuro interventionalists to better remove blood...
March 28, 2021
Cardiovascular / Cardiology
Qardio Lands 510(k) for Ambulatory ECG Device
Qardio, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company 510k clearance for its QardioCore ambulatory ECG device.  QardioCore will initially be marketed for holter monitoring applications, for use with QardioMD, Qardio’s cloud-based remote patient monitoring solution....
March 21, 2021
Cardiovascular / Cardiology
Imbio Receives FDA 510(k) Clearance for New Cardiothoracic Imaging Algorithm
Imbio, a leading provider of artificial intelligence (AI) solutions for medical imaging analysis, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its RV/LV Analysis™ algorithm. The RV/LV Analysis algorithm is a rapid, automated assessment of potential right ventricular dilation. The...
March 21, 2021
Cardiovascular / Cardiology
Access Vascular Inc. Secures $20 Million in Series B Financing
Access Vascular, Inc., a company addressing the most common and costly venous access complications, today announced it has closed on a Series B round of financing. TVM Capital Life Science led the round with a $15 million commitment, with existing...
March 14, 2021
Cardiovascular / Cardiology
Shockwave Intravascular Lithotripsy FDA Approved to Treat Advanced Heart Disease
Shockwave Medical, Inc., a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced last month that the company’s sonic pressure wave therapy received Pre-Market Approval for severely calcified coronary artery disease from the U.S....
March 7, 2021
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