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Elucid cardio imaging tech wins FDA clearance

Published

26 October 2026

Topic

opportunities

◆ Sectors

Medtech

◆ Geography

United States

◆ Source

Read at massdevice.com →

◆ Verified

Fusion42 · 26 October 2026 · Fusion42 review

Elucid has received FDA clearance for its AI-powered FFR-IQ software which noninvasively estimates fractional flow reserve from coronary CT angiography, aiding physicians in identifying patients needing invasive cardiac evaluation. The company also integrates FFR-IQ with Plaque-IQ into a comprehensive platform assessing coronary anatomy, physiology, and plaque biology to enhance personalised cardiology care.

This Wire brief sits within Fusion42's coverage of Medtech.

◆ ◆ The Wire takeaway

Your cardiology AI product must now consider combining anatomy and physiological data into one tool to stay competitive. Elucid’s 510(k) clearance opens a path to replace invasive tests with AI-powered diagnostics that doctors want.

◆ Coverage

1 source · 26 Oct 2026

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Medtechfda-clearancecardio-imagingai-healthtechnoninvasive-diagnostics