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2 clusters · 4 sources · 5 days · First seen · Last updated

FDA clearance of cardiovascular AI imaging tools

Overview

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to new artificial intelligence-based software solutions for cardiovascular assessment.

Coreline Soft received clearance for ‘AVIEW Aorta Metrics,’ an automated aortic analysis solution. The software utilizes chest CT images to automatically segment the aorta and provide quantitative measurements of anatomical diameters. This marks the company’s 13th FDA clearance, expanding its technological reach from pulmonary diseases into the cardiovascular domain.

Additionally, Elucid received FDA clearance for FFR-IQ, a software designed for the noninvasive estimation of fractional flow reserve from coronary CT angiography (FFR-CT). The tool incorporates coronary anatomy and plaque composition to assist physicians in identifying patients who may require revascularization, potentially reducing the need for invasive catheterizations. In the ELUCIDATE FFR-CT study, the software demonstrated a sensitivity of 92.2% and a specificity of 93.1%.

Entities

Coreline Soft · U.S. Food and Drug Administration · 3DR Labs · FDA · Elucid

Timeline

  1. [HEALTH] 3 sources
    FDA clears AI-powered cardiovascular imaging software

    The FDA has cleared Elucid’s FFR-IQ software for noninvasive cardiovascular assessment and Coreline Soft’s AVIEW Aorta Metrics.

  2. [TECHNOLOGY] 2 sources
    Coreline Soft receives FDA clearance for AI aortic analysis software

    Coreline Soft received FDA clearance for ‘AVIEW Aorta Metrics’, an AI solution that automatically analyzes the aorta in chest CT scans, expanding its cardiovascular technology portfolio in the U.S. market.

Sources

bosa.co.kr · diagnosticimaging.com · journalofclinicalpathways.com · thebionews.net

This summary has been updated 1 time: see revision history