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Cleerly Launches Cleerly ISCHEMIA Solution for Heart Disease Analysis

DAIC

milla1cf Tue, 01/09/2024 - 11:32 January 9, 2024 — Cleerly , the company working to create a new standard of care for the diagnosis of heart disease, announced the launch of Cleerly ISCHEMIA , which recently received U.S. Cleerly ISCHEMIA is a transformative addition poised to reshape the landscape of cardiac care.”

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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

It further reported that these results underscore the strong and positive effect of the Cleerly products on clinical utility for patients with suspected coronary artery disease. “We High Diagnostic Accuracy Of AI-Ischemia in Comparison To PET, FFR-CT, SPECT, and Invasive FFR: A PACIFIC Sub-Study. James Min, M.D.

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GE Healthcare Launches New Cardiac PET tracer

DAIC

In 2024, the FDA approved Flyrcado for patients with known or suspected coronary artery disease (CAD), delivering higher diagnostic efficacy compared to single-photon emission computed tomography (SPECT) i myocardial perfusion imaging (MPI), the predominant procedure used in nuclear cardiology today.

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FDA Breakthrough Device Designation for Biotronik Freesolve Below-the-Knee Resorbable Magnesium Scaffold (RMS)

DAIC

The Freesolve BTK RMS is designed for individuals suffering from chronic limb-threatening ischemia (CLTI). CLTI is the most severe form of peripheral arterial disease (PAD), estimated to affect 11% of the 200 million people suffering from PAD globally. For more information: www.biotronik.com References: 1 Kwong M.,

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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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HeartFlow Achieves Landmark Milestone of 250,000 Patients Assessed for Coronary Artery Disease (CAD) with FFRCT Analysis

DAIC

Traditional methods of non-invasive ischemia testing (stress EKG , stress echo, SPECT , PET , direct-to-cath) can result in false negatives 20-30 percent of the time, which can lead to undetected disease, and false positives over 50 percent of the time, which can lead to unnecessary invasive procedures.

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GE HealthCare and Medis Medical Imaging Announce Collaboration Focused on Non-Invasive Coronary Assessments to Help Advance Precision Care in Treatment of Coronary Artery Disease

DAIC

Together, the two companies will work to further the development and commercialization of Medis Quantitative Flow Ratio (Medis QFR), a non-invasive approach to the assessment of coronary physiology, as part of GE HealthCare’s interventional cardiology portfolio built around the Allia Platform.