The Latest Cardiac and Vascular News
Remote Patient Monitoring Platform Provides Continuous Vital Sign Measurement and Patient Deterioration Identification Capabilities In Hospital and Home Settings PETAH TIKVA, Israel , May 4, 2021 /PRNewswire/ — Biobeat, a global leader in wearable remote patient monitoring solutions for the healthcare continuum, announced today that its full AI-powered wearable remote patient monitoring platform has received a […]
FDA approval results in the only label of its kind for more than 3 million patients in the United States, significantly expanding AtriCure’s addressable market Superiority trial showed a 29% difference in effectiveness at 12 months and a 35% difference in effectiveness at 18 months for long-standing persistent Afib patients. Study […]
Giving IMS a First Mover Advantage – The Only 100% Cloud-Based FDA Cleared Cinematic Solution on the Market TORONTO, April 28, 2021 /PRNewswire/ — International Medical Solutions (“IMS”), one of the first cloud-native technologies to enable the remote, seamless, and instant view of medical DICOM images in the cloud received FDA Class II […]
MONTREAL–(BUSINESS WIRE)–Soundbite announces FDA 510(k) Approval for SoundBite® Crossing System – Peripheral (SCS-P) with the 0.014” Active Wire (14P). The SoundBite® Crossing System – Peripheral (14P) is a recanalization tool, designed to help physician’s placement of conventional guidewires or treatment devices in the intraluminal space beyond chronic total occlusions (CTOs) in […]
Patient Enrollment to Begin Within Three Months FREMONT, Calif. and OXFORD, United Kingdom, April 21, 2021 /PRNewswire/ — Cerus Endovascular Ltd., a privately held, commercial-stage medical device company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application to conduct a U.S. trial for the Contour […]
First Patient Receives New Shield Surface Modification, An Advance in Flow Diversion Therapy, at NYU Langone Health DUBLIN, April 21, 2021 /PRNewswire/ — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received approval from the United States Food and Drug Administration (FDA) for Pipeline™ Flex Embolization Device […]
Intuitive, optical-based technology system now available around the world LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for B-Capta®, the new in-line, blood-gas monitoring system integrated into the market-leading S5® heart-lung machine (HLM). The system is […]
RALEIGH, N.C., April 16, 2021 /PRNewswire/ — Contego Medical, Inc., a leading developer of innovative cardiovascular devices, today announced receipt of CE Mark approval for the Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System). The patented Neuroguard IEP System contains a novel, next-generation nitinol stent, a […]
MONMOUTH JUNCTION, N.J., April 19, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care leader whose flagship E.U. approved CytoSorb® blood purification technology is intended to treat deadly conditions in critically-ill and cardiac surgery patients, announces that the U.S. Food and Drug Administration (FDA) has granted conditional approval of its investigational device exemption (IDE) application for […]
Aquilion ONE / PRISM Edition Now Offers AI Powered Spectral Capabilities for Cardiac Exams TUSTIN, Calif.–(BUSINESS WIRE)–Meeting the growing cardiovascular needs of healthcare providers today, Canon Medical Systems USA, Inc. announces that its Deep Learning Spectral CT has received 510(k) clearance for expanded capabilities into cardiovascular applications. Available on the company’s Aquilion ONE […]
