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HyperVue Imaging System with X1-FFR

Coronary Artery Disease - PCI Guidance

CommercialActive

Key Facts

Indication
Coronary Artery Disease - PCI Guidance
Phase
Commercial
Status
Active
Company

About SpectraWAVE

SpectraWAVE is a private, commercial-stage medical device company based in Cambridge, Massachusetts, focused on transforming coronary care. The company's integrated HyperVue platform merges high-definition intravascular imaging (DeepOCT+NIRS) with an AI-enabled, wire-free fractional flow reserve (FFR) measurement tool (X1-FFR), designed to streamline workflow in the catheterization lab. With 50+ employees and a vertically integrated operation in Bedford, MA, SpectraWAVE targets the significant global market for coronary artery disease by providing a unified solution for anatomical and physiological assessment. The company received 510(k) clearance for its X1-FFR technology in October 2025, marking a key regulatory milestone.

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