Cardiovascular / Cardiology

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 mission to extend its comprehensive cardiological services to patients who are prescribed monitoring devices by…

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 of caval reflux present in cases of severe tricuspid regurgitation, without removal of the defective…

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 clots and restore blood flow the brain following an ischemic event—a condition that devastates 800,000…

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. QardioCore extends Qardio’s remote patient monitoring platform from primary care and hypertension monitoring to acute…

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 tool quickly and accurately measures the ventricles of the heart to provide the ratio of…

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 investors also participating. Access Vascular has developed a proprietary biomaterial platform that is both hydrophilic and lubricious,…

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. Food and Drug Administration (FDA). The innovative technology, which was granted Breakthrough Device designation by…

Implicity, the leading remote cardiac monitoring company in Europe, officially announced its rollout into the US market via its partnership with the Phoenix-based company, IronRod Health. Implicity and IronRod have been nominated for The Prix Galien Medstartup USA in the category of “Best collaboration in the Medtech and Digital health sector”, organized by the Galien…

The U.S. Food and Drug Administration (FDA) has granted Vascular Perfusion Solutions, Inc. (VPS) a Breakthrough Device Designation for its groundbreaking VP.S Encore™ oxygenated perfusion cardiac transport device. The patent-pending technology uses oxygen to enable preserving vascularized tissue for eight hours, and more, doubling the viability of organs beyond the current standard of care. As…

Puzzle Medical Devices Inc., (www.puzzlemed.com) announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for its revolutionary transcatheter pump to address heart failure. The FDA Breakthrough Device Program is intended to help patients receive more timely access to certain medical devices that have the potential to…