Other News

RapidAI Achieves Record Momentum Amid Demand for Improved Clinical Decision Making and Patient Workflow

Leader in neurovascular and vascular imaging analysis gains worldwide momentum with extended NTAP reimbursement, record number of scans, product innovation, new partnerships, and influential board members SAN MATEO, Calif., Aug. 19, 2021 /PRNewswire/ — RapidAI, the global leader in neurovascular and vascular imaging driving the next evolution of clinical decision making and patient […]

Five-year Results Of The GORE® EXCLUDER® Iliac Branch Endoprosthesis Pivotal U.S. Multicenter Study Confirm Safety, Efficacy and Durability

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 […]

First Ever Analysis of TCAR in Standard Surgical Risk Patients Demonstrates Clinical Benefits in Large Comparative Dataset

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 […]

FDA Completes On-site Pre-Approval Inspection of Liquidia’s Morrisville, North Carolina Facility

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 […]

BioSig’s Signal Processing System for Arrhythmia Care To Be Featured At The Kansas City Heart Rhythm Symposium

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 […]

Fist Assist Devices, LLC Announces Release of the p-FACT Cohort Data

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 […]

CardioNXT wins FDA nod for heart treatment delivery platform

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 […]

FDA Grants Breakthrough Device Designation to Impella ECP, the World’s Smallest Heart Pump

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 […]

Latest Study Shows New Algorithm Can Predict Heart Failure Hospitalizations

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 […]