The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Abiomed’s new 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.
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FDA Grants Breakthrough Device Designation to Impella ECP

August 20, 2021 – The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Abiomed’s ...

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Gallery | HIMSS | By Dave Fornell, Editor
Photo Gallery of New Technologies at HIMSS 2021

The annual Healthcare Information Management Systems Society (HIMSS) 2021 meeting is the largest health information ...

Home August 18, 2021
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The American Heart Association announced its support this week for the CDC and FDA recommendation that immuno-compromised patients should receive a third dose of the Pfizer or Moderna COVID vaccines. Getty Images #AHA #coronavirus #COVID19
News | Coronavirus (COVID-19) | By Dave Fornell, Editor
American Heart Association Supports COVID Vaccine Boosters Suggested by the CDC

August 18, 2021 — The U.S. Centers for Disease Control and Prevention (CDC) recommended Friday a third dose of the ...

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Videos | Cardiovascular Ultrasound
VIDEO: Examples of Dynamic Blood Flow Imaging in Cardiac Ultrasound

A new ultrasound imaging technology that may offer novel ways to diagnose and better understand cardiac diseases using ...

Home August 17, 2021
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A comparison of color-flow Doppler cardiac ultrasound showing blood flow, and blood speckle tracking revealing a more detailed and complex understanding of the low. It shows the formation of a vortex that may play a role in future assessments for the efficiency of flow in the heart and vessels. #ASE21 #ASE2021 #Vectorflowimaging
Feature | Cardiac Imaging | By Dave Fornell, Editor
Development of Echo Blood Flow Dynamics Imaging

In the past several years, a few cardiac ultrasound vendors have developed new ways to image the intricate flow of ...

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The Abbott Amplatzer Amulet left atrial appendage (LAA) transcatheter occlusion device. It received FDA clearance in August 2021. #LAA
News | Left Atrial Appendage (LAA) Occluders
FDA Clears Abbott Amplatzer Amulet LAA Occluder to Reduce Stroke in People With Atrial Fibrillation

August 16, 2021 — The U.S. Food and Drug Administration (FDA) approved Abbott's Amplatzer Amulet Left Atrial Appendage ...

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A lone vendor booth in a sea of open space in a corner of the expo floor at HIMSS 2021 this week. A large number of vendors decided to pull out of exhibiting at HIMSS in recent weeks because the host city of Las Vegas saw a major surge of COVID cases over July, reaching a 20.2% positivity rate on the day HIMSS began.  
Blog | Coronavirus (COVID-19)
HIMSS 2021 Showed What to Expect From In-person Healthcare Conferences During the COVID Pandemic

The in-person 2021 Healthcare Information Management Systems Society (HIMSS) meeting planned for Aug. 9-13 appeared to ...

Home August 13, 2021
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Artificial intelligence is becoming best practice to support clinical decisions and help standardize echocardiography analysis for practices. AI, trained on millions of outcome-based data, can provide automation for operators to obtain highly accurate and precise measurements, to better detect and predict cardiovascular disease.
Webinar | Artificial Intelligence
WEBINAR: Utilization of AI for Echocardiography Analysis and Outcome Prediction

Artificial intelligence is becoming best practice to support clinical decisions and help standardize echocardiography ...

Home August 12, 2021
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Boston Scientific Corp. has commenced enrollment in the HI-PEITHO clinical trial, a collaborative research study with the Pulmonary Embolism Response Team (PERT) Consortium and the University Medical Center of the Johannes Gutenberg University of Mainz comparing use of the EkoSonic Endovascular System in combination with anticoagulation to anticoagulation alone for the treatment of acute, intermediate-high-risk pulmonary embolism (PE).
News | Pulmonary Embolism
Study Compares Interventional Pulmonary Embolism Therapy in Combination With Anticoagulation to Anticoagulation Alone

August 9, 2021 — Boston Scientific Corp. has commenced enrollment in the HI-PEITHO clinical trial, a collaborative ...

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BioMonitor IIIm is a miniature electrocardiogram (ECG) device which records, stores and transmits clinical data that is integral in the diagnosis and long-term monitoring of cardiac patients, with maximum precision and for an extended period of time.
News | Implantable Cardiac Monitor (ICM)
Biotronik Implantable Cardiac Monitor Receives Prestigious Industry Award

August 9, 2021 - In association with Heart Rhythm 2021, Biotronik today announced that the latest implantable cardiac ...

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Ventricular Tachycardia Recurrence, Hospitalization and Death Reduced With Catheter Ablation as First Line Therapy. Results from an international clinical trial show a significant reduction in risk of ventricular tachycardia (VT) recurrence, cardiovascular hospitalization, and sudden cardiac death (SCD) death when catheter ablation is used as an early first-line treatment for patients with structural heart disease. Led by study coordinating center, the University of Chicago, The PAUSE-SCD trial. #HRS21
News | EP Lab
Ventricular Tachycardia Recurrence, Hospitalization and Death Reduced With Catheter Ablation as First Line Therapy

August 9, 2021 – Results from an international clinical trial show a significant reduction in risk of ventricular ...

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The Adagio Medical iCLAS cryoablation system is commercial in Europe and is also part of an ongoing FDA IDE trial in the U.S. #HRS21
News | Atrial Fibrillation
Pulsed Field Cryoablation Eliminated AF in 85% After Single Ablation Procedure

August 9, 2021 — Adagio Medical Inc., a provider of catheter ablation technologies for atrial fibrillation (AF) and ...

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Heart Rhythm Society, HRS, 2021 Late-Breaking Clinical Trials in Electrophysiology. #HRS #HRS2021 #HRS21 #Heartrhythm21
Feature | EP Lab
Heart Rhythm Society 2021 Late-Breaking Clinical Trials in Electrophysiology

July 28, 2021 — Here is the complete list of late-breaking clinical trials (LBCT) and links to articles on all of them ...

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The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death
News | Pacemakers
Boston Scientific Recalls INGENIO Family of Pacemakers

August 9, 2021 — Boston Scientific is recalling INGENIO family of pacemakers and CRT-Ps due to the risk of incorrect ...

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An example from the study of the Biosense Webster NuVision 3D/4D ICE imaging capability showing the left atrial appendage (LAA) visualization on 3D ICE. The system allows the user to place a false lighting source to be placed in different positions to change the lighting and shadows to better visualize the anatomy.
News | EP Lab | By Dave Fornell, Editor
First-in-Human Experience With Novel 4D ICE Catheter For Catheter Ablation and LAA Closure Procedures

August 5, 2021 — A prospective, non-randomized, multicenter, first-in-human clinical study found good diagnostic and ...

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