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Catheter Device Articles & Analysis
17 news found
STEMart, a US-based provider of comprehensive services for all phases of medical device development, announces the expansion of its medical device testing capabilities and introduces Balloon Catheter Testing Services for the development of safe and effective medical devices. ...
BySTEMart
This technology enables real-time accurate situational awareness of catheters and implantable devices in relation to complex anatomy. “I am honored to work with the innovative team at UC Davis Health,” said EchoPixel founder and CEO Sergio Aguirre. ...
Over 90% met the primary endpoint of complete or near-complete thrombus extraction and there was only one device-related serious adverse event. There were no reports of valve damage, vessel damage, or acute kidney injury (AKI). ...
Reflow Medical, Inc. announces that it has completed patient enrollment in the DEEPER OUS clinical trial (NCT03807531) for the company’s Temporary Spur Stent System, a novel device that features a retrievable stent designed for complex infrapopliteal disease. 106 patients have now been enrolled in the prospective, nonrandomized trial in multiple centers in Europe and New ...
EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges ...
Reflow Medical, Inc., a California- based medical device company, announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved the Wingman™ CTO Catheter. Reflow Medical has partnered with Century Medical, Inc. (CMI), a leading medical device distributor based in Tokyo, to introduce the Wingman ...
Before Walrus came along, balloon-based variable stiffness catheters brought all manner of technological constraints. Not anymore. ...
COPENHAGEN, Denmark--(BUSINESS WIRE)--Neurescue, a medical device company developing innovative cardiovascular solutions to improve the outcomes for emergency patients, today announced that the U.S. ...
Habib Frost and headquartered in Copenhagen, Denmark, aims to bring that survival rate to 9 out of 10 people with its new device. Currently under U.S. Food and Drug Administration review, the Neurescue device is designed to increase blood flow to the brain and heart during life-threatening emergencies. ...
The objective of the SAVE Registry was to report Surfacer Inside-Out® Access Catheter System device performance and safety information for patients with thoracic central venous obstruction (TCVO) requiring central venous access. Central venous catheters were successfully placed in 29 of 30 patients (96.7%) with no ...
Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the planned acquisition of Avenu Medical, a privately held medical device company based in San Juan Capistrano, Calif. focused on the endovascular (minimally invasive) creation of arteriovenous (AV) fistulae for patients with end-stage renal disease (ESRD) undergoing dialysis. ...
This wireless powered device is substantially similar to the Second Heart Assist catheter based device that completed a successful pilot clinical study in 2019 but with the added ability to disconnect the drive shaft and catheter and switch over to wireless power. ...
May 19,2020 - Thermedicak a developer of thermal-ablation medical systems to treat ventricular tachycardia (VT): today announced that it has received Breakthrough Device Designation from the U.S. Food & Drug Administration (FDA) for its Saline Enhanced Radiofrequency (SERF) Ablation system and Durablate® catheter. The FDA Breakthrough ...
The Minnesota Department of Health (MDH) states that CA-MRSA infections are defined as MRSA infections in people with no history of the following risk factors within the year prior to the MRSA culture date: · Hospitalization or surgery · Permanent indwelling catheters or percutaneous medical devices · Residence in a ...
Houston medical device developer Procyrion Inc. today announced they have won the Most Innovative Heart Pump Technology award in the 2018 Global Healthcare and Pharmaceutical Awards for their device, Aortix™, a catheter-deployed circulatory support device designed initially to address cardiorenal syndrome in heart failure ...
Comprised of a subcutaneous “flusher” component and a ventricular catheter, the device has a “relief membrane” backup feature at the catheter’s proximal end. ...
SAN FRANCISCO, May 17, 2017 /PRNewswire/ -- CrossBay Medical, Inc., today announced receipt of United States Food and Drug Administration (FDA) clearance of its product, the CrossBay IVF Embryo Transfer Catheter Set. The device has also received clearance to commercialize the product in Europe by obtaining its CE mark. ...