A cardiac scan on the new Siemens Naeotom Alpha. This is the first commercialized photon-counting CT scanner. It gained FDA clearance Sept. 30, 2021. Image by Deutscher Zukunftpreis/Ansgar Pudenz.
Feature | Computed Tomography (CT) | By Dave Fornell, DAIC Editor
First Photon-counting CT System Cleared by the FDA

The U.S. Food and Drug Administration (FDA) Sept. 30 cleared the world's first photon-counting computed tomography (CT) ...

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Videos | EP Lab
VIDEO: Antibacterial Envelope for EP Devices Reduced Infections in Patients With Hemotomas by 82 Percent
Khaldoun Tarakji, M.D., MPH, associate section head, cardiac electrophysiology, Heart and Vascular Institute at ...
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Gadolinium-enhanced MRI of a cardiac radiation therapy patient at baseline (left) and 3 months post-treatment (right). Top: the left ventricle with patchy, gadolinium-enhanced scar was transmurally targeted with a radiation ose of 25 Gy between 3 and 6 o’clock (red brackets). Nonenhanced, remote myocardium is adjacent to target region (white arrowhead). Bottom: surviving nonenhanced myocardium within the same images is visible in the targeted region at baseline and 3 months post-treatment (yellow outline).
Feature | EP Lab
Radiation Therapy Reprograms Heart Cells to Younger State

September 28, 2021 — New research from Washington University School of Medicine in St. Louis suggests that radiation ...

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Biotricity Inc., a medical diagnostic and consumer healthcare technology company, has developed a personal medical device kit, Biokit, that includes a bundled of home-use devices to monitor cardiovascular disease. It includes a digital thermometer, a pulse oximeter and a blood pressure cuff. All three devices are U.S. FDA cleared, wireless, wearable, and integrate into the Biotricity ecosystem, a platform for interconnectivity. 
News | Cardiac Diagnostics
Biotricity Releases Biokit With Three Home Monitoring Devices for Cardiac Disease Management

September 28, 2021 — Biotricity Inc., a medical diagnostic and consumer healthcare technology company, has developed a ...

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Videos | Structural Heart
VIDEO: Roles of the Melody and Harmony Transcatheter Pulmonary Valves in Congenital Heart Disease

Tom Jones, M.D., director, cardiac cath labs, Seattle Children’s Hospital, and principle investigator of the Medtronic ...

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CardioMEMS is a wireless, battery-free sensor that is implanted into the pulmonary artery via a right heart catheterization procedure to transmit pulmonary artery pressures.
News | Heart Failure
GUIDE-HF Trial Shows Hemodynamic Guided Management Benefits Larger Heart Failure Population

September 28, 2021 — Hemodynamic guided management using the CardioMEMS device may reduce heart failure hospitalizations ...

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COVID Long-hauler Symptoms May be Caused by Antibody Attacks on ACE2
News | Coronavirus (COVID-19)
COVID Long-hauler Symptoms May be Caused by Antibody Attacks on ACE2

September 28, 2021 — A research team at the University of Arkansas for Medical Sciences (UAMS) has identified a ...

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High-resolution 3-D delayed enhancement MRI of the left atrium can be used for quantification of fibrosis based on relative intensity of contrast enhancement The DECAAF study found this may help determine which patients will benefit from fibrosis ablation combined with PVI, and which ones are best served with the PVI.
News | Atrial Fibrillation
Fibrosis Ablation Shows Promise in AFib With Low Grade Fibrotic Myopathy

September 28, 2021 — Image-guided fibrosis ablation in addition to pulmonary vein isolation (PVI) does not improve ...

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Zebra Medical Vision now offers artificial intelligence (A) medical imaging analytics for its cardiac solution HealthCCSng, which enables the quantification of the coronary artery calcium (CAC) on CT scans as an incidental finding. Zebra gained FDA clearance for the product in September 2021.
News | Artificial Intelligence
FDA Clears Zebra Coronary Artery Calcium Solution as Part of Its Population Health Offering

September 27, 2021 — Zebra Medical Vision, the deep-learning medical imaging analytics company, announces its eighth U.S ...

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Illustration of the Watchman transcatheter left atrial appendage (LAA) occluder being  deployed into the LAA. FDA is concerned about higher rates of LAA occlusion complications in women compared to men, prompting the FDA to send a letter to providers warning them on possible poor outcomes.
Feature | Left Atrial Appendage (LAA) Occluders
FDA Concerned About Higher Rates of LAA Occlusion Complications in Women

September 27, 2021 — Compared with men undergoing left atrial appendage occlusion (LAAO), women have a significantly ...

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Test selection should be a shared decision between patient and physician rather than directed by insurers’ test substitution policies, according to a statement published online in the Journal of the American College of Cardiology.[1] The statement summarizes the proceedings of a recent summit convened by the American Society of Nuclear Cardiology (ASNC), leadership of the American College of Cardiology Imaging Council, American Society of Echocardiography (ASE), Society of Cardiovascular Computed Tomography
News | Cardiac Imaging
Cardiovascular Imaging Organizations Denounce Test Substitution by Insurance Companies

September 22, 2021 — Test selection should be a shared decision between patient and physician rather than directed by ...

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Cardiothoracic surgeons with UofL Health – Jewish Hospital and the University of Louisville performed the world’s first Carmat Aeson bioprosthetic total artificial heart implantation in a female patient on Sept. 14, 2021. The device was small enough to fit into the woman's smaller chest cavity. The device is being tested as a bridge to heart transplant rather than use of a LVAD. Photo by UofL Health.
News | Heart Failure
First Woman in World Receives New Type of Artificial Heart 

September 22, 2021 — A cardiothoracic surgical team with University of Louisville Health – Jewish Hospital has performed ...

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ESC Releases Guidelines on Heart Failure Management
News | Heart Failure
ESC Releases Guidelines on Heart Failure Management

September 21, 2021 — The European Society of Cardiology (ESC) Guidelines for the diagnosis and treatment of acute and ...

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Medtronic is recalling its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology, which are transcatheter devices used to seal brain aneurysms. The company said there is a risk of the delivery system’s wire and tubes fracturing and breaking off when the system is being used to place, retrieve, or move the stent inside a patient.
News | Cath Lab
Medtronic Recalls Neurovascular Pipeline Flex Embolization Devices for Risk of Fractures During Placement, Retrieval or Movement of Device

September 21, 2021 — Medtronic is recalling its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device ...

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The U.S. Food and Drug Administration (FDA) has cleared the company's Portico with FlexNav transcatheter aortic valve replacement (TAVR) system to treat people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery. 
Feature | Structural Heart Occluders | By Dave Fornell, Editor
FDA Clears Abbott Portico TAVR System to Treat Aortic Valve Disease

September 20, 2021 — Abbott announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Portico ...

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