Medical technology company Elucid has received the 510(k) clearance from the US Food and Drug Administration (FDA) for its PlaqueIQ imaging analysis software.
PlaqueIQ is now approved in the US to help physicians diagnose cardiovascular disease (CVD). This technology offers physicians information about the type and amount of plaque in arteries, which can lead to heart attack and stroke.
It is now said to be the first FDA-cleared non-invasive software that can objectively quantify and classify plaque morphology based on ground-truth histology, the gold standard for characterisation of plaques.
PlaqueIQ is designed to give physicians new, clinically validated information to help stratify patients and inform patient-specific treatment pathways.
The imaging analysis tool uses first-line diagnostic coronary computed tomography angiography (CCTA) to create comprehensive, interactive reports. This allows physicians to visualise plaque at the vessel level.
The software non-invasively quantifies and characterises non-calcified plaque, including components like lipid-rich necrotic core (LRNC). This capability offers insights into high-risk plaques that increase the risk of heart attack and stroke.
Additionally, PlaqueIQ can help identify higher-risk plaque earlier, even before symptoms or major adverse events.
According to the Boston-based medical technology firm, physicians can easily send patient images to Elucid with just one click.
The firm then uses PlaqueIQ’s image-restoration algorithms to reduce motion and calcium-blooming artifacts.
Analysts then segment the data to create a 3D model of the patient’s coronary arteries. The software identifies, classifies, and quantifies the tissue structure and composition.
Elucid CEO Kelly Huang said: “Elucid’s mission is to commercialise proven technologies that can make a meaningful difference in the prevalence of heart attack and stroke, and the FDA clearance of PlaqueIQ is a huge step forward towards that goal.
“We know that plaque is the key contributor to these devastating events, and, specifically, high-risk plaque components, but you can’t treat what you can’t see.”
Elucid is currently beta testing PlaqueIQ and expects a limited release in Q4 2024.
The company is also examining PlaqueIQ technology for non-invasive measurement of fractional flow reserve (FFRCT). The technology will help assess coronary blockages and the extent of ischemia.
Elucid focuses on providing physicians with a clearer view of atherosclerosis, the primary cause of cardiovascular disease.
In late 2023, the medical technology firm raised $80m in Series C funding round led by Elevage Medical Technologies.
