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AliveCor Announces Dual FDA Clearance of AI Technology That Delivers 35 Cardiac Determinations and First-of-its-Kind Kardia 12L ECG System

DAIC

Food and Drug Administration ( FDA ) clearance and commercial launch of KAI 12L AI technology and the Kardia 12L ECG System. The Kardia 12L ECG System, featuring a game-changing patented technology, is the world’s first AI-powered handheld 12-lead electrocardiogram ( ECG ) system with a unique single-cable design.

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GE Healthcare Launches New Cardiac PET tracer

DAIC

ii to show blood flow through the heart muscle and evaluate the presence, extent and degree of myocardial ischemia or infarction. Around 6 million MPI procedures are undertaken each year in theU.S. Flyrcado is now available in selectU.S.markets.

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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). Biotronik 's focus on vascular interventional excellence is evident in our strategic investments and persistent dedication to innovation”, said Dr. Jörg Pochert, President of Vascular Intervention at Biotronik.

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

DAIC

The CAD Staging System is a noninvasive imaging-based investigational software device that analyzes important and actionable features of coronary atherosclerosis, stenosis and ischemia. Cleerly is committed to accelerating the availability of its technology to healthcare providers and patients alike.

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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

According to the company, Earls is a leader within the field of radiology and specializes in applications of advanced imaging technologies in cardiovascular care. He is the author of over 150 articles, book chapters, abstracts and other publications on advanced imaging technologies. Earls, MD , Chief Medical Officer of Cleerly.

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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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PCI for stable angina : Sham trials are welcome, but not OMT shaming trials !

Dr. S. Venkatesan MD

The costly aftermath Over the last three decades, PCI armed with a variety of technologies and expanded with explosive indications, has grown into a monster intervention (including the life-saving primary PCI). In the process, the abuse prevailed over the use, causing considerable damage.

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