The Evolut FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access
News | FDA
Medtronic Announces FDA Approval of Newest-generation Evolut TAVR System for Treatment of Symptomatic Severe Aortic Stenosis

March 28, 2024 — Medtronic plc, a global leader in healthcare technology, announced that the United States Food and Drug ...

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Findings from the admIRE study – freedom from atrial arrhythmia recurrence at 12 months – support the submission of the VARIPULSE Platform among U.S. patients
News | Atrial Fibrillation
Biosense Webster Submits Application to U.S. FDA Seeking Approval of the VARIPULSE Platform for the Treatment of Paroxysmal Atrial Fibrillation

March 28, 2024 — Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson ...

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CREDENCE and PACIFIC-1 study data demonstrate potential power of AI-QCT ISCHEMIA
News | Artificial Intelligence
Robust Diagnostic Accuracy and Prognostic Utility in Analyses from Large Scale Clinical Trials

March 28, 2024 — Cleerly, the company on a mission to create a new standard of care to aid in the diagnosis of heart ...

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News | FDA
FDA Approves Johnson & Johnson OPSYNVI (macitentan and tadalafil) Single-Tablet Combination for Patients with Pulmonary Arterial Hypertension (PAH)

March 27, 2024 — Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has approved OPSYNVI – ...

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Elixir Medical has announced it has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its DynamX BTK System, a novel, adaptive implant for use in the treatment of narrowed or blocked vessels below-the-knee (BTK) in patients with chronic limb-threatening ischemia (CLTI). The company reports this broadens the use of the novel bioadaptor platform technology beyond the treatment of coronary artery disease.
News | FDA
Elixir Medical Receives FDA Breakthrough Device Designation for DynamX BTK System for Below-The-Knee Arterial Disease

March 27, 2024 — Elixir Medical has announced it has been granted Breakthrough Device Designation by the U.S. Food and ...

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The largest prospective registry of its kind will build upon clinical data supporting the use of plaque insights to empower clinical decision making for patients with suspected coronary artery disease
News | Artificial Intelligence
HeartFlow Initiates DECIDE Registry to Evaluate Utility of HeartFlow AI-Enabled Plaque Analysis for Patients with Suspected Coronary Artery Disease

March 27 2024 — HeartFlow, Inc., a leader in AI-driven healthcare technology, announced the launch of the DECIDE ...

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WINREVAIR on top of background therapy significantly improved exercise capacity and multiple important secondary outcome measures compared to background therapy alone
News | FDA
FDA Approves Merck’s WINREVAIR, a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension

March 27, 2024 — Merck, known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug ...

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Esperion announced the acceptance of three CLEAR (Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen) Outcomes subgroup analyses as poster presentations at ACC24
News | Cardiovascular Clinical Studies
Esperion Announces Data from CLEAR Outcomes Sub-Groups as Poster Presentations, Moderated Session and Industry Expert Theatre to be Presented at ACC.24

March 26, 2024 — Esperion announced the acceptance of three CLEAR (Cholesterol Lowering via Bempedoic acid, an ACL ...

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Medical imaging AI company receives approval for algorithms enabling incidental detection of pulmonary embolism and automatic assessment of stroke severity
News | FDA
Avicenna.AI Secures FDA Clearance for Two Healthcare AI Solutions

March 26, 2024 — Medical imaging AI company Avicenna.AI announced that it has received 510(k) clearance from the US Food ...

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Bristol Myers Squibb has announced that it will present data on CAMZYOS (mavacamten) for NYHA class II-III obstructive hypertrophic cardiomyopathy at the American College of Cardiology (ACC) Annual Scientific Session & Expo, ACC.24, taking place April 6-8, 2024 in Atlanta, Georgia.
News | ACC
Bristol Myers Squibb to Present Data on CAMZYOS (mavacamten) for obstructive hypertrophic cardiomyopathy (HCM) at American College of Cardiology Annual Scientific Session, ACC.24

March 26, 2024 — Bristol Myers Squibb has announced that it will present data on CAMZYOS (mavacamten) for NYHA class II ...

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UC San Diego Health is the first in San Diego to successfully implant the world’s first dual chamber and leadless pacemaker system to help treat people with abnormal heart rhythms
News | Pacemakers
UC San Diego Health First in Region to Implant Dual Chamber, Leadless Pacemaker

March 26, 2024 — UC San Diego Health is the first health system in San Diego to successfully implant the world’s first ...

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Here is a look at the education and special events planned for the ACC24 73rd Annual Scientific Session & Expo, April 6-8 in Atlanta
Feature | ACC | By Melinda Taschetta-Millane
American College of Cardiology (ACC24) Show Preview: Advancing Cardiovascular Care for All

The American College of Cardiology (ACC) has announced key educational and programming highlights for its ACC 73rd ...

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The cutting-edge procedure that avoids open-heart surgery is momentous in cardiac care
News | Structural Heart
CLS Health Cardiologists Achieve Historic First with Transcarotid TAVR in Southeast Houston

March 25, 2024 — In a groundbreaking medical advancement, three esteemed cardiologists from CLS Health, Dr. Bahaeddin ...

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Abbott announced the first patient has been enrolled in the ENVISION investigational device exemption (IDE) clinical trial. 
News | Cardiovascular Clinical Studies
Abbott Announces First Procedures in ENVISION Trial of Navitor TAVI System to Treat Patients With Severe Aortic Stenosis

March 25, 2024 — Abbott announced the first patient has been enrolled in the ENVISION investigational device exemption ...

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A bioelectronic mesh, studded with graphene sensors (red), can measure the electrical signal and movement of cardiac tissue (purple and green) at the same time.
News | Heart Failure
UMass Amherst Engineers Create Bioelectronic Mesh Capable of Growing with Cardiac Tissues for Comprehensive Heart Monitoring

March 25, 2024 — A team of engineers led by the University of Massachusetts Amherst and including colleagues from the ...

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