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Cleerly Receives FDA Breakthrough Device Designation for Heart Disease Risk Staging System

DAIC

milla1cf Wed, 03/06/2024 - 18:48 March 6, 2024 — Cleerly , the company on a mission to create a new standard of care to aid in the diagnosis of heart disease, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration ( FDA ) for its Coronary Artery Disease ( CAD ) Staging System.

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Robust Diagnostic Accuracy and Prognostic Utility in Analyses from Large Scale Clinical Trials

DAIC

milla1cf Thu, 03/28/2024 - 07:00 March 28, 2024 — Cleerly , the company on a mission to create a new standard of care to aid in the diagnosis of heart disease, shared findings from a study published online in the Journal of the American College of Cardiology: Cardiovascular Imaging on March 13, 2024.

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Results of CERTAIN Study Demonstrate Prominent Effects of Cleerly Products on Changing Clinical Management for Patients Suspected of Coronary Artery Disease

DAIC

Cleerly, a digital healthcare company focused on heart disease, has announced continued strong scientific evidence supporting the clinical utility of its products, detailing a study published online on Jan. 25, 2024 in the European Heart Journal Cardiovascular Imaging. Earls, MD , Chief Medical Officer of Cleerly.

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The Role of Genetics in Heart Disease: Can You Prevent It?

MIBHS

Heart disease remains one of the leading causes of death worldwide, often attributed to a mix of lifestyle choices, environmental factors, and genetic predispositions. Understanding the Genetic Connection to Heart Disease Your genetic makeup plays a vital role in shaping your heart health.

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Researchers develop nanoparticle technology for targeted diagnosis and treatment of atherosclerosis

Science Daily - Heart Disease

A team developed a nanoparticle technology that offers an effective solution to diagnose and treat atherosclerosis, in a non-invasive manner.

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HeartLung.AI Tool Receives 'FDA Breakthrough' AI Clearance

DAIC

30, 2024 — HeartLung Technologies , a developer of AI tools for early detection of heart disease, lung cancer and other conditions announced that its AI-enabled Automated Cardiac Chambers Volumetry (AutoChamber) recently received “Breakthrough Medical Device” designation and marketing authorization from the U.S. “By

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Orchestra BioMed Announces Initiation of BACKBEAT Pivotal Study of AVIM Therapy in Hypertensive Pacemaker Patients

DAIC

milla1cf Fri, 01/19/2024 - 10:55 January 19, 2024 — Orchestra BioMed , a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the first patient was randomized in the BACKBEAT pivotal study in late December 2023. billion adults worldwide. Circulation. 2017; 135: e146.

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