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Luma Vision secures US FDA clearance to expand capabilities of Verafeye platform
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Fusion42 · 17 September 2026 · Fusion42 review
Luma Vision has received US FDA clearance to expand its Verafeye platform, integrating imaging, visualisation, navigation, and catheter guidance into a single AI-driven system for cardiac procedures. This platform offers real-time anatomical modelling and catheter tracking with CT-like accuracy, improving procedural intelligence and workflow in cardiac labs.
This Wire brief sits within Fusion42's coverage of Medtech, and 2 sources have reported it between 14 Sep 2026 and 17 Sep 2026.
◆ ◆ The Wire takeaway
Medtech founders in cardiac imaging should move fast to integrate AI-driven procedural guidance into their tools as regulation now favours unified platforms over fragmented systems. This clearance cuts through physician workflow barriers and opens surgeon adoption for smarter cardiac procedure management.
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2 sources · first reported 14 Sep 2026 · latest 17 Sep 2026
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