LightLab nets FDA clearance

Optical coherence tomography (OCT) technology developer LightLab Imaging has received U.S. Food and Drug Administration (FDA) clearance for its C7-XR coronary imaging system and companion C7 Dragonfly imaging catheter.

C7-XR and the C7 Dragonfly create high-resolution 50-mm coronary scans in less than three seconds without the vessel occlusion required by earlier-generation OCT systems, according to the Westford, MA-based vendor. The systems provide intravascular resolution at 15 µm, due to simultaneous analysis of thousands of data points at high speeds, LightLab said.

LightLab believes its new technology allows clinicians to see and measure important vessel characteristics otherwise invisible or difficult to observe with older intracoronary imaging modalities.

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