medical device guru

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

Cardiovascular / Cardiology

Implicity Rolls Out AI-Empowered Remote Cardiac Monitoring to Over 10,000 Patients

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...

February 21, 2021

Cardiovascular / Cardiology

Vascular Perfusion Solutions Lands FDA Breakthrough Designation for Organ-Transport Device

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...

February 14, 2021

Cardiovascular / Cardiology

Puzzle Medical Receives FDA Breakthrough Device Designation for Transcatheter Heart Pump

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...

February 14, 2021

Cardiovascular / Cardiology

Medtronic Wins FDA Approval for DiamondTemp Ablation System

Medtronic, the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval of the DiamondTemp Ablation (DTA) system which treats patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) and who have been unresponsive...

January 30, 2021