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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Feature | Intra-Vascular Ultrasound (IVUS) | By Dave Fornell, DAIC Editor
Advances in Intravascular Ultrasound Technologies

Intravascular ultrasound (IVUS) is the workhorse intravascular imaging modality in cardiac cath labs. It is used to help ...

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HeartFlow, Inc., a leader in revolutionizing precision heart care, announced the commencement of the REVEALPLAQUE (A pRospEctiVe, multicEnter study to AnaLyze PLAQUE using CCTA) trial to evaluate HeartFlow’s non-invasive plaque technology, an automated, deep learning-based method for identifying, characterizing and segmenting plaque in the coronary arteries
News | Computed Tomography (CT)
HeartFlow Announces Enrollment of First Two Patients in REVEALPLAQUE Trial

October 20, 2021 — HeartFlow Inc. announced the commencement of the REVEALPLAQUE (A pRospEctiVe, multicEnter study to ...

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Philips, a global leader in health technology and IVUS solutions, announced that a worldwide committee of 40 cross-specialty medical experts achieved the first-ever consensus for the appropriate use of intravascular ultrasound (IVUS) in peripheral vascular disease (PVD) interventions
News | Intra-Vascular Ultrasound (IVUS)
First-ever Global Consensus for the Appropriate Use of IVUS in Peripheral Vascular Disease Interventions

October 20, 2021 — Philips, a global leader in health technology and intravascular ultrasound (IVUS) solutions ...

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The objective of this clinical investigation has been to evaluate safety and performance outcomes of SELUTION SLR, MedAlliance’s novel sirolimus-eluting balloon, for the treatment of long tibial occlusive lesions (TASC C & D) in patients with Critical Limb Ischemia (CLI). It was presented at VIVA 2021.
News | Drug-Eluting Balloons
18-Month Below-the-Knee Data With MedAlliance’s SELUTION SLR Presented at VIVA

October 20, 2021 — 18-month results from the PRESTIGE* Below-the-Knee (BTK) study have been presented as a late-breaking ...

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the Eluvia stent exhibited superiority with a primary patency rate of 85.4% versus 76.3% with BMS (p=0.0077).1 The analysis also confirmed a significantly greater rate of sustained clinical improvement without reintervention
News | Peripheral Artery Disease (PAD)
Boston Scientific Eluvia Drug-Eluting Vascular Stent System Exhibits Superiority Compared to Bare Metal Stents

October 20, 2021 — Boston Scientific Corporation announced positive data for the Eluvia Drug-Eluting Vascular Stent ...

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