The Latest Cardiac and Vascular News
FLAGSTAFF, Ariz., Aug. 19, 2021 /PRNewswire/ — W. L. Gore & Associates (Gore), today announced that five-year results of the U.S. prospective, multicenter study (N = 63) of endovascular repair of iliac aneurysms using the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) were presented at the 2021 Society for Vascular Surgery Annual Meeting. Results of the […]
Large-Scale Analysis of TCAR in The Treatment of Standard Surgical Risk Patients Presented at The Society for Vascular Surgery 2021 Vascular Annual Meeting SUNNYVALE, Calif., Aug. 18, 2021 (GLOBE NEWSWIRE) — Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, is […]
No Form 483 observations were issued during 5-day inspection MORRISVILLE, N.C., Aug. 18, 2021 (GLOBE NEWSWIRE) — Liquidia Corporation (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) has completed an on-site Pre-Approval Inspection (PAI) of its Morrisville, North Carolina facility in connection with the on-going review […]
A physician user from a leading medical center of excellence will present the technology and discuss recent clinical data Westport, CT, Aug. 19, 2021 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative biomedical signal processing platform designed to improve […]
FA-1 Device Significantly Dilates the Perforator Vein for Improved EndoAVF Placement LOS ALTOS HILLS, Calif.–(BUSINESS WIRE)–Fist Assist Devices, LLC, announces that data associated with the p-FACT cohort, a data subset of the recently completed, non-significant risk Fist Assist Clinical Trial (FACT Trial) that focused on vein dilation in stage 4 […]
BOULDER, Colo., Aug. 18, 2021 /PRNewswire/ — CardioNXT announced today that it received marketing clearance from the U.S. Food and Drug Administration (FDA) for the platform technology comprised of the iMap 3D Navigation & Mapping System™, Activate Software™, Sensor Enabled Axis Patient Patches™, and MultiLink Sensor Enabled Catheter™. The CardioNXT technology platform enables […]
DANVERS, Mass.–(BUSINESS WIRE)–The United States Food and Drug Administration (FDA) has granted breakthrough device designation to Abiomed’s (NASDAQ: ABMD) Impella ECP expandable percutaneous heart pump. The designation means the FDA will prioritize Impella ECP’s regulatory review processes including design iterations, clinical study protocols and pre-market approval (PMA) application. Impella ECP is the smallest […]
SELENE HF adds to existing evidence that HF decompensation starts several weeks before hospitalization BERLIN, Aug. 18, 2021 /PRNewswire/ — BIOTRONIK today announced the results from a new study published in EUROPACE this week confirming that heart failure (HF) decompensation can be predicted early when monitored using an algorithm that combines existing remote monitoring trends and baseline […]
Latest Addition to the Kosmos Platform Now Enables Full-Body Imaging at Point-of-Care in a Hand-Carried Device REDMOND, Wash.–(BUSINESS WIRE)–EchoNous, the leader in portable AI-guided ultrasound tools and software, announced today that the U. S. Food and Drug Administration (FDA) has cleared Lexsa, the company’s new 128-channel linear probe, for use […]
NEWTOWN, Pa., Aug. 17, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that it has received Breakthrough Designation from the U.S. Food and Drug Administration (“FDA”) for its PoNS™ device with the proposed indication for […]
