The Latest Cardiac and Vascular News
Novel 3-in-1 system provides predictable left atrium access to support transseptal interventions MIAMI, July 13, 2021 /PRNewswire/ — East End Medical, a private medical device company committed to improving catheter-based cardiac procedures, today announced it received U.S. Food and Drug Administration (FDA) clearance for the company’s SafeCross™ Transseptal Radiofrequency (RF) Puncture & Steerable Balloon […]
First of its Kind FDA Action Allows In-Office and At-Home Measurement for Potentially Life-Threatening Side Effect of Certain Medications MOUNTAIN VIEW, Calif., July 8, 2021 /PRNewswire/ — AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology and services, today announced it received 510(k) clearance by the U.S. Food and Drug Administration (FDA) […]
MONMOUTH JUNCTION, N.J., July 6, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO) announces the full approval of its Investigational Device Exemption (IDE) application to conduct the pivotal STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) double-blind, randomized, controlled trial (RCT) in the United States to support FDA regulatory clearance. This study is being performed under the previously announced FDA Breakthrough […]
– New labeling approval for Abbott’s XIENCE™ stent builds on a legacy of safety and allows for one-month (as short as 28 days) dual anti-platelet therapy (DAPT) for patients at high bleeding risk (HBR) – The new XIENCE Skypoint™ stent received FDA approval in the U.S. and CE Mark approval […]
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed’s (NASDAQ: ABMD) newest right heart pump, the Impella RP with SmartAssist, has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) as safe and effective to treat acute right heart failure for up to 14 days. Impella RP with SmartAssist is the first single-access temporary percutaneous ventricular […]
After three years of research and development, Front Line Medical Technologies introduces the world’s smallest REBOA device to control bleeding and help patients survive emergencies LONDON, Ontario, June 29, 2021 (GLOBE NEWSWIRE) — Front Line Medical Technologies, Inc. announced today that the U.S. Food and Drug Administration (FDA) has cleared its COBRA-OS™ […]
AngelMed Guardian® System prompts high-risk ACS patients to seek medical care EATONTOWN, N.J., June 28, 2021 /PRNewswire/ — Angel Medical Systems, Inc., (dba AngelMed) a proactive diagnostics company focused on the advancement of long-term management of high-risk coronary disease, announced today the FDA approval of the second-generation AngelMed Guardian® device. The AngelMed Guardian System […]
Now available in the U.S., RED™ 62 is engineered with optimized trackability to help navigate the complex distal vessel anatomy in the brain and deliver powerful aspiration for the removal of blood clots First catheter of new RED series expands the company’s extensive portfolio of innovative stroke products ALAMEDA, Calif.–(BUSINESS WIRE)–Penumbra, […]
LOS ALTOS HILLS, Calif.–(BUSINESS WIRE)–Fist Assist Devices, LLC, has received FDA 510(k) clearance for use of the Fist Assist FA-1 device in the United States as an arm massage and increased vein circulation device and has commenced marketing the Fist Assist FA-1 device for that indication for use. “We are […]
Charlottesville, VA June 22, 2021 – Caretaker Medical, developer of the Caretaker™ Wireless Hemodynamic Patient Monitor has been selected for MedTech Innovator’s Annual Showcase and Accelerator for 2021. Caretaker Medical was selected from a field of over 1100 companies across 50 countries as one of the Top 50 MedTech firms […]
