FDA Grants 510(k) Clearance to PlaqueIQ Imaging Analysis Software

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Elucid for its PlaqueIQ™ imaging analysis software to aid with the diagnosis of cardiovascular disease (CVD).¹

Announced by Elucid on October 1, 2024, PlaqueIQ is the first cleared non-invasive software capable of objectively quantifying and classifying plaque morphology based on ground-truth histology. Elucid indicated that PlaqueIQ allows physicians to gather new, clinically validated information to stratify patients and better inform relevant treatment pathways.

The company is currently performing beta testing on PlaqueIQ and expects to make the software available for limited release in late Q4 of this year.

“It’s time to shift our focus from merely estimating risk and treating risk of myocardial infarction (MI) to directly visualizing and treating the disease itself by looking at the coronary arteries,” said Amir Ahmadi, clinical associate professor of medicine and cardiology, Icahn School of Medicine at Mount Sinai. “I believe that PlaqueIQ will enable physicians to better ‘see’ the disease–specifically plaque quantity and type—so that we can treat patients with greater precision and in a personalized manner, improve their quality of life, and ultimately present MI and stroke more effectively.”

CVD is largely driven by MI and stroke caused by atherosclerosis and marks the most common cause of mortality worldwide.² Although physicians evaluate multiple risk factors for CVD, including age, diet, and lifestyle, the amount and type of plaque in a patient’s arteries are the strongest predictor of future CV events.

PlaqueIQ is based on first-line diagnostic cardiac computed tomography angiography (CCTA) and can develop all-encompassing, interacting reports for physicians to visualize plaque at the vessel level virtually.¹ Its basis in histology can non-invasively calculate and characterize non-calcified plaque and relevant components, including the lipid-rich necrotic core (LRNC).

This can provide physicians potential insight into high-risk plaque that remain key drivers of MI and stroke, according to Elucid. The software also has the capability to enable earlier recognition of higher-risk plaque, before the presence of symptoms or major adverse events.

“Armed with additional data on vulnerable plaque components, we can make more informed decisions on drug therapy selection or the need to send the patient to the cath lab,” said Mark Rabbat, professor of medicine and radiology, director of cardiac CT, and director of structural heart disease interventional imaging in the division of cardiology at Loyola University Chicago. “I believe plaque quantification has the potential to greatly improve outcomes for patients while tremendous savings to the healthcare system.”

Physicians utilizing PlaqueIQ can send the patient images with one click, and Elucid will apply the imaging analysis software’s image-restoration algorithm to mitigate motion and calcium blooming artifacts. Trained analysts will segment the data to create a 3D model of the patient’s coronary arteries—from there, the software will identify, classify, and quantify tissue structure and composition.

“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,” said Kelly Huang, chief executive officer of Elucid. “With PlaqueIQ, physicians can gain new and insightful histology-based information to help better understand plaque composition and get ahead of the disease.”

References

1. _{Morin S. ELUCID receives U.S. 510(K) clearance of plaqueiqTM image analysis software to aid cardiovascular disease assessment. Elucid. October 1, 2024. Accessed October 1, 2024. https://elucid.com/elucid-receives-u-s-510k-clearance-of-plaqueiq-image-analysis-software-to-aid-cardiovascular-disease-assessment/.}
2. _{Pahwa R, Jialal I. Atherosclerosis. [Updated 2023 Aug 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK507799/}