Research indicates that around half of US adults aged 45 to 84 have atherosclerosis or plaque build-up in their arteries, a key risk factor in cardiovascular disease, but are not aware of it. Image credit: sweet_tomato via Shutterstock.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Elucid’s PlaqueIQ, an artificial intelligence (AI)-powered image analysis software designed to detect arterial plaque build-up for cardiovascular disease (CVD).

CVD is largely driven by myocardial infarction (MI) and ischemic strokes caused by plaque build-up and rupturing of the arteries (atherosclerosis). While physicians assess various metrics including age, diet, and lifestyle factors to assess CVC risk, research indicates that the amount and type of plaque patients have in their arteries is the strongest predictor of future events.

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US-based Elucid’s PlaqueIQ software quantifies and classifies plaque morphology based on ground-truth histology.

Following coronary computed tomography angiography (CCTA) for the production of 3D images of the heart’s blood vessels, Elucid states that its software applies AI-based image-restoration algorithms to mitigate motion and calcium blooming artifacts to create an interactive image to help physicians virtually “see” plaque at the vessel level.

Elucid claims that its software is uniquely able to non-invasively quantify and characterise non-calcified plaque and its components such as lipid-rich necrotic core (LRNC), giving physicians insight into high-risk plaques that are key risk drivers in heart attack and stroke.

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Elucid CEO Kelly Huang commented: “We know that plaque is the key contributor to these [heart attack and stroke] devastating events, and, specifically, high-risk plaque components, but you can’t treat what you can’t see.

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“With PlaqueIQ, physicians can gain new and insightful histology-based information to help better understand plaque composition and get ahead of the disease.”

Elucid is currently performing beta testing on PlaqueIQ and anticipates making the software available for limited release later this year. The company is also seeking an indication for the software in fractional flow reserve for the measurement of coronary blockages and the extent of ischemia.

In November 2023, Elucid closed an $80m Series C funding round to support PlaqueIQ’s development.

A 2023 report by GlobalData forecasts that AI platforms in healthcare will reach a valuation of $18.8bn by 2027.