FDA Grants Empagliflozin Breakthrough Therapy Status for Heart Failure With Preserved Ejection Fraction. he U.S. Food and Drug Administration (FDA) recently granted the breakthrough therapy designation for empagliflozin (Jardiance) as an investigational treatment for adults with heart failure with preserved ejection fraction (HFpEF).
October 07, 2021
FDA Grants Empagliflozin Breakthrough Therapy Status for Heart Failure With Preserved Ejection Fraction
October 7, 2021 – The U.S. Food and Drug Administration (FDA) recently granted the breakthrough therapy designation for…
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The Baylis VersaCross RF transseptal crossing catheter is designed to puncture the septum without a needle to allow access to the left side of the heart for mitral valve and left atrial appendage occlusion procedures. Boston Scientific to Acquire Baylis Medical for $1.75 billion.
October 06, 2021
Boston Scientific to Acquire Baylis Medical To Expand EP and Structural Heart Portfolios
October 6, 2021 — Boston Scientific Corp. announced it entered into a definitive agreement to acquire Baylis Medical…
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Two of the top technology headlines this past month was the FDA clearance of the Abbott Portico transcatheter aortic valve replacement (TAVR) device, and the first women to receive a Carmat artificial heart.
BY Dave Fornell, DAIC Editor
October 06, 2021
Most Popular Cardiology Technology Content in September 2021
October 6, 2021 — Here is the list of the most popular content on the Diagnostic and Interventional Cardiology (DAIC)…
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October 06, 2021
First Human AFib Cases in Europe Treated Using Heliostar Balloon Ablation Catheter
October 6, 2021 – Biosense Webster announced the first cases using a radiofrequency balloon ablation catheter were…
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A comparison between healthy artery (left) and inflamed artery (right) using perivascular fat attenuation index (FAI) mapping to detect spatial changes in perivascular fat composition induced by inflammation of the vascular wall caused by high-risk plaques.
October 06, 2021
CT Coronary Perivascular Fat Assessment Can Stratify Cardiac Risk Associated With High-Risk Plaques
October 6, 2021 — Data presented during the late-breaking science session at the European Society of Cardiology (ESC)…
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Cardiac coronary computed tomography angiography (CCTA) exam showing different views of the myocardium and the coronary arteries. This was scanned on a Canon Aquilion Prime CT scanner. Trends in cardiac imaging. Cardiac imaging utilization report.
October 06, 2021
Trends in Cardiac Imaging Over Past Decade Shows Rapid Rise in CT
October 6, 2021 – A new study published in Radiology: Cardiothoracic Imaging on cardiac imaging trends over a decade…
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SimpleSense is an FDA cleared remote diagnostic platform. The cloth-based nanosensor technology undergarment monitors multiple patient vitals such as heart rate, blood pressure, respiration rate, and physical activity.
October 04, 2021
FDA Clears Nanowear Platform to Implement AI-based Home Diagnostics and Monitoring Network
October 4, 2021 – Nanowear, a hospital-at-home and remote diagnostic platform that used  proprietary wearable cloth…
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The Abbott Amplatzer Talisman PFO Occlusion System is designed to treat people with a patent foramen ovale (PFO). The small opening between the upper chambers of the heart can increase the risk of recurrent ischemic stroke.
October 04, 2021
FDA Clears Abbott Amplatzer Talisman PFO Occluder 
October 4, 2021 — U.S. Food and Drug Administration (FDA) has cleared the Abbott Amplatzer Talisman PFO Occlusion…
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The GE Healthcare Vsan Air wireless transducer point-of-care-ultrasound system will be used in combination with UltraSight artificial intelligence technology to monitor an astronaut's heart during Rakia space mission. The research will be used to determine the possible side effects of long-duration maned flights to Mars.
October 04, 2021
AI Enabled Wireless Cardiac Point-of-Care-Ultrasound Will be Used by Astronauts in Space
October 4, 2021 – UltraSight, a digital health company developing artificial intelligence (AI) enabled cardiac imaging…
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European Society of Cardiology 2021 Late-breaking hot-line Studies presented with links.
By Dave Fornell, DAIC Editor
October 04, 2021
European Society of Cardiology 2021 Late-breaking Studies 
October 4, 2021 — Here are links to all the late-breaking cardiology studies presented in Hot-Line sessions at the 2021…
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A pooled analysis of two randomized trials has demonstrated the beneficial effects of empagliflozin in patients with heart failure with a reduced and preserved ejection fraction. The late breaking study is presented in a Hot Line at the European Society of Cardiology (ESC) 2021 Congress, and was published in the New England Journal of Medicine. Data from the EMPEROR-Preserved and in EMPEROR-Reduced trials.
October 04, 2021
Empagliflozin Benefits Heart Failure Patients With Reduced and Preserved Ejection Fraction
October 1, 2021 — A pooled analysis of two randomized trials has demonstrated the beneficial effects of empagliflozin…
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October 04, 2021
ESC Issues Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy
October 1, 2021 — The European Society of Cardiology (ESC) guidelines on cardiac pacing and cardiac resynchronization…
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MASTER DAPT Shows 1-month Dual Antiplatelet Therapy After Stent Benefits High Bleeding Risk Patients, DAPT. #ESCCongress
October 04, 2021
MASTER DAPT Shows 1-month Dual Antiplatelet Therapy After Stent Benefits High Bleeding Risk Patients
October 4, 2021 —  One month of dual antiplatelet therapy (DAPT) following stent implantation in high bleeding risk…
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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.
By Dave Fornell, DAIC Editor
October 04, 2021
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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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).
September 28, 2021
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. 
September 28, 2021
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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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.
September 28, 2021
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…
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COVID Long-hauler Symptoms May be Caused by Antibody Attacks on ACE2
September 28, 2021
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.
September 28, 2021
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.
September 27, 2021
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.…
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