AI Cardiovascular Risk Diagnostic by Elucid Receives FDA Approval

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Elucid, a US-based company, has recently received FDA approval for its AI-powered image analysis software, PlaqueIQ, which is designed to detect arterial plaque build-up for cardiovascular disease (CVD). This software aims to help physicians visualize arterial plaque build-up and assess patients’ risk of CVD, particularly focusing on high-risk plaque components that can lead to heart attacks and strokes.

CVD, driven by myocardial infarction (MI) and ischemic strokes caused by plaque build-up and rupturing of the arteries (atherosclerosis), is a significant health concern for many adults in the US. Research indicates that around half of US adults aged 45 to 84 have atherosclerosis or plaque build-up in their arteries, which can be a silent risk factor for cardiovascular events.

PlaqueIQ works by quantifying and classifying plaque morphology based on ground-truth histology. By utilizing coronary computed tomography angiography (CCTA) to produce 3D images of the heart’s blood vessels, the software can provide interactive images that help physicians identify and analyze plaque at the vessel level. This technology allows for the non-invasive quantification and characterization of non-calcified plaque and its components, such as lipid-rich necrotic core (LRNC), giving valuable insights into high-risk plaques.

Elucid’s CEO, Kelly Huang, highlighted the importance of being able to visualize and understand plaque composition to better manage and prevent cardiovascular events. The company is currently undergoing beta testing for PlaqueIQ and plans to release the software for limited use later this year. Additionally, Elucid is seeking an indication for the software in fractional flow reserve to measure coronary blockages and assess the extent of ischemia.

With the increasing adoption of AI platforms in healthcare, the market is expected to reach a valuation of $18.8 billion by 2027. Elucid’s innovative approach to using AI for cardiovascular risk assessment aligns with this growing trend towards leveraging technology to improve patient outcomes and enhance diagnostic capabilities in the healthcare industry. The FDA approval of PlaqueIQ marks a significant milestone for Elucid and underscores the potential of AI-driven solutions in transforming cardiovascular care.

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