Tag: AFib

CardioFocus® Announces Initial Commercial Procedures Following US FDA Approval of HeartLight® X3 System for the Treatment of Atrial Fibrillation

MARLBOROUGH, Mass., June 16, 2020 /PRNewswire/ — CardioFocus, Inc. today announced that the first U.S. patients have been treated commercially with the recently-approved HeartLight® X3 Endoscopic Ablation System. The revolutionary cardiac ablation technology is designed to treat drug refractory, symptomatic paroxysmal atrial fibrillation (AFib), the […]

New Study Shows Two-Lead CRT-DX System Can Provide Equivalent Therapy With Fewer Complications

Sub-Analysis Of Large Multi-Center Study Shows DX Technology Provides Similar CRT Responses To Conventional Three-Lead System With Reduced Risk LAKE OSWEGO, Ore., May 27, 2020 /PRNewswire/ — Results recently published in the Journal of Cardiovascular Electrophysiology confirm that BIOTRONIK’s unique two-lead CRT-DX system provides equivalent […]

Clinical Data Evaluating Gencaro for the Treatment of Atrial Fibrillation in Heart Failure Patients Featured in Three Presentations at the 2020 Heart Rhythm Scientific Sessions

New data provide additional evidence of efficacy for Gencaro compared to active control in a pharmacogenetically-defined HF population at risk for AF recurrence °  26% reduction in total time spent in AF (p < 0.001) °  30% decrease in AF interventions […]

AltaThera Pharmaceuticals Announces FDA Approval for New Indications of Sotalol IV: A New and Faster Way to Initiate Sotalol Therapy for Atrial Fibrillation (AFib) Patients

– Sotalol IV is now approved for 1-day hospital outpatient initiation of AFib therapy and faster dose escalations for existing patients – New FDA-approved dosing, monitoring and evaluation shortens the hospital stay from 3 days to 1 day – The […]

CardioFocus Announces U.S. FDA PMA Supplement Submission For The Breakthrough HeartLight X3 Endoscopic Ablation System

MARLBOROUGH, Mass., Feb. 4, 2020 /PRNewswire/ — CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), today announced that the company has submitted a pre-market approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for […]

Late-Breaking Clinical Study Presented at AF Symposium 2020 Evaluates Attune Medical’s ensoETM For Use During Cardiac Ablation Procedures

CHICAGO–(BUSINESS WIRE)–Chicago-based medical device firm Attune Medical announced the presentation of clinical results from the largest device study to date designed to evaluate the performance of its ensoETM patient temperature management device as an aid in the reduction of esophageal […]

FDA Clears Eko’s AFib and Heart Murmur Detection Algorithms, Making It the First AI-Powered Stethoscope to Screen for Serious Heart Conditions

Eko’s algorithms alert clinicians to the presence of heart murmurs and atrial fibrillation (AFib) during the physical exam, converting the classic stethoscope into a powerful early detection tool SAN FRANCISCO–(BUSINESS WIRE)–Eko, a digital health company applying artificial intelligence (AI) in […]

Correvio Receives Complete Response Letter From U.S. FDA for Brinavess and Provides Update on Recent Events

NASDAQ: CORV TSX: CORV VANCOUVER, Dec. 24, 2019 /PRNewswire/ – Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the […]