Katherine Fornell, age 5, from suburban Chicago, receives her first dose of the COVID-19 vaccine during the first week it became available in the U.S. The FDA authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine Oct. 29 for the prevention of COVID-19 in children 5 to 11 years of age. This was based on a safety review of more than 3,000 patients receiving the vaccine ages 5-11.
Feature | Coronavirus (COVID-19)
FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Children Ages 5-11

November 5, 2021 — The U.S. Food and Drug Administration (FDA) authorized the emergency use of the Pfizer-BioNTech COVID ...

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American Society of Nuclear Cardiology (ASNC) President Randy Thompson, M.D., getting his COVID-19 vaccine when the vaccines first became available last December. Nearly a year later, some healthcare workers are still holding out and refuse to get the vaccine, which prompted CMS (Medicare) to now require COVID vaccinations for all healthcare workers at facilities that accept Medicare and Medicaid patients.
Feature | Coronavirus (COVID-19) | By Dave Fornell, DAIC Editor
CMS Now Requires COVID-19 Vaccinations for Healthcare Workers by January 4

November 4, 2021 — The Centers for Medicare and Medicaid Services (CMS) today issued an emergency regulation now ...

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Figures from an initial study on the Cardionomic CPNS technology in a poster presentation at the Heart Rhythm Society (HRS) 2021 meeting.[1]  Starting at top left, an angiographic view of the atrial transseptal access for a left ventricular septal ablation. Procedural intra-cardiac echo (ICE) showing ablation catheter positioning. A 3D electro-anatomic map of the LV septum. The final graphs show baseline and post-procedure LVOT pressure readings demonstrating a decreased gradient.
News | Heart Failure
First U.S. Patient Enrolled in Cardiac Pulmonary Nerve Stimulation Pilot Study to Treat Heart Failure

November 2, 2021 — Cardionomic Inc. announce initial U.S. enrollment in its global Cardiac Pulmonary Nerve Stimulation ...

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Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) left, and the Cardiosave Rescue Intra-Aortic Balloon Pump. Both systems have a recall because of reports that the battery can fail.
News | Intra-Aortic Balloon Pumps (IABP)
Cardiosave Intra-Aortic Balloon Pumps Recalled Due to Battery Failure

November 2, 2021 — Datascope/Getinge/Maquet is recalling its Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pumps (IABP) ...

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T1-Based Criteria for Myocarditis on Cardiac MRI in Patients With Recent COVID-19 mRNA Vaccination: Early gadolinium enhancement (EGE) compared with precontrast SSFP sequence (not shown) is observed on early postcontrast short-axis SSFP images in (A) 16-year-old male, (B) 17-year-old male, (C) 16-year-old male, and (D) 19-year-old male, and on early postcontrast short-axis perfusion image in (E) 17-year-old male (arrow, A-E). Late gadolinium enhancement (LGE) is also present (arrows) in all 5 patients (F, G
News | Cardiac Imaging
Cardiac MRI of Myocarditis After COVID-19 Vaccination in Adolescents

November 1, 2021 — According to ARRS’ American Journal of Roentgenology (AJR), radiologists need to be cognizant of the ...

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The FDA cleared the world's first photon-counting computed tomography (CT) scanner, the Siemens Naeotom Alpha, in late September. This new technology will likely change the future direction of CT. Biosense Webster also announced the first cases using its Heliostar radiofrequency balloon ablation catheter were completed in September. Both were among the top stories in October.
Feature | By Dave Fornell, DAIC Editor
Most Popular Cardiology Technology Content in October 2021

November 1, 2021 — Here is the list of the most popular content on the Diagnostic and Interventional Cardiology (DAIC) ...

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The Vagus Breathe ECG app for the Apple Watch is the first test to measure the exact breathing flow with an electrocardiogram (ECG) recording. It uses a 30-second breathing test for wearable device. It is being used to monitor long-COVID patients.
News | Wearables
Apple Watch Adds New Breathing Test Based on ECG Analysis

November 1, 2021 — Health AI company Vagus.co, based in Cambridge, U.K., has launched a 30-second breathing test for ...

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Cardiac CT Given Strong Recommendation as Front-line Imaging of Chest Pain, but the American Society of Nuclear Cardiology (ASNC) did not support the guidelines.
Feature | Cardiac Diagnostics | By Dave Fornell, DAIC Editor
First International Chest Pain Diagnosis Guidelines Released

October 29, 2021 — A new guideline for the evaluation and diagnosis of chest pain was released this week that provides ...

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Implicity provides a remote cardiac monitoring and research platform used by Independent Diagnostic Testing Facilities and medical centers to deliver high-quality care for patients with connected cardiac devices. On this platform, Implicity aggregates, normalizes and standardizes data from any implantable cardiac device across all manufacturers.
Feature | EP Lab | By Arnaud Rosier, M.D.
Addressing Physician Concerns About Missing CIED Patient Data

With 1.2 to 1.4 million new electrophysiology (EP) devices being prescribed to patients around the world each year ...

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BioCardia's CardiAMP cell therapy uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. The therapy incorporates a pre-procedural screening assay to identify those patients who are likely responders to the therapy, a first for a cardiac cell therapy. 
News | Stem Cell Therapies
BioCardia Announces First Patient Treated in CardiAMP Cell Therapy Trial for Chronic Myocardial Ischemia

October 28, 2021 – The first patient has been treated in a new trial using stem cell therapy to treat chronic myocardial ...

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The CathVision's novel EP recording technology and amplifier ECGenius used artificial intelligence (AI) confirms if pulmonary vein isolation (PVI) is complete to reduce need for repeat EP ablations procedures.
News | EP Lab
CathVision Announces First Patient Enrollments in PVISION Multicenter Clinical Study

October 28, 2021 — CathVision, a medical technology company developing electrophysiology (EP) solutions in EP recording ...

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Cardiovascular Ultrasound Analytics Aids Re-accreditation Process 
Sponsored Content | Feature | Analytics Software
The Benefits of Data Analytics in Clinical Reporting

Accurate reporting is essential to producing the reliable analytics needed to meet lab accreditation standards. This is ...

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News | Heart Failure
FDA Revises Impulse Dynamics Optimizer Smart Device Labeling Opening it to More Patients

October 27, 2021 — Impulse Dynamics announced the U.S. Food and Drug Administration approved a modification of labeling ...

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News | Cardiac Resynchronization Therapy Devices (CRT)
Leadless CRT Can Deliver Left Bundle Branch Area Pacing for Cardiac Resynchronization

October 27, 2021 ​​— EBR Systems Inc., developer of the world’s first wireless cardiac pacing system for heart failure ...

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QuickClot already has an FDA-cleared product for use for vascular access hemostasis management in cath lab procedures. The hemostatic technology consists of a non-woven material impregnated with kaolin, an inorganic mineral. When kaolin contacts blood it activates Factor XII, which accelerates the body’s natural clotting cascade.
News | Hemostasis Management
Teleflex Completes Enrollment in IDE Study of QuickClot in Cardiac Surgery

October 27, 2021 — Teleflex Inc. announced the completion of patient enrollment in a clinical study evaluating the ...

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