medical device guru

Cardiovascular / Cardiology
FDA Clears geko Muscle Pump Activator to Prevent VTE
Sky Medical Technology Ltd, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its geko™ device for stimulation of the calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism (VTE). This adds to Sky’s...
October 16, 2019
Cardiovascular / Cardiology
AngioDynamics Acquires Eximo Medical, Ltd. and its Innovative 355nm Laser Atherectomy Technology 
AngioDynamics, Inc., a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, today announced that it has acquired Eximo Medical, Ltd., an early commercial stage, medical device company, and its proprietary 355nm wavelength...
October 9, 2019
Cardiovascular / Cardiology
Medtronic Receives FDA Breakthrough Device Designation for Developing Stent Graft System to Treat Thoracoabdominal Aortic Aneurysm 
Medtronic today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Valiant® TAAA Stent Graft System for minimally invasive repair of thoracoabdominal aortic aneurysm (TAAA). A TAAA is a complex condition causing...
October 9, 2019
Cardiovascular / Cardiology
Cardiovascular Systems, Inc. Announces FDA Approval of the Coronary ViperWire Advance® With Flex Tip 
Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced U.S. Food and Drug Administration (FDA) PMA approval of the new ViperWire Advance® Coronary...
September 24, 2019
Cardiovascular / Cardiology
BIOLIFE4D Bioprints Small Human Heart for the First Time in the U.S.
BIOLIFE4D, one of the pioneers in the bioprinting field, has been able to bioprint a miniature human heart – making it the first U.S. company to successfully achieve this. The company’s mission is to create a fully functioning human heart through...
September 23, 2019
Cardiovascular / Cardiology
Biotronik First to Land MDR Certification for a High-Risk Device
Biotronik said that it is the first medtech manufacturer to receive European Medical Device Regulation (MDR) certification for a Class III (highest risk) medical device. The newly certified device is Biotronik’s Renamic programmer software, which enables physicians to program and test...
September 19, 2019
Cardiovascular / Cardiology
Saranas Launches Early Bird® Bleed Monitoring System in the U.S.
Saranas, Inc. announced the commercial launch of the Early Bird Bleed Monitoring System in the United States. The Early Bird is the first and only device for the monitoring and early detection of endovascular bleed complications through a novel application of bioimpedance sensors....
September 19, 2019
Cardiovascular / Cardiology
FDA Phase 1 Trial Shows Hydrogel to Repair Heart Is Safe to Inject in Humans—A First
Ventrix, a University of California San Diego spin-off company, has successfully conducted a first-in-human, FDA-approved Phase 1 clinical trial of an injectable hydrogel that aims to repair damage and restore cardiac function in heart failure patients who previously suffered a...
September 18, 2019
Cardiovascular / Cardiology
Abbott Wins CE Mark for Pediatric Heart Devices 
Abbott said today that it won CE Mark approval for its Masters HP mechanical heart valve and Amplatzer Piccolo occluder. The Masters HP is the world’s smallest mechanical heart valve (15mm) and is designed for implantation in the mitral or...
September 17, 2019
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