LightLab Imaging Inc. won 510(k) clearance May 3 from the Food & Drug Administration for its C7-XR imaging system and companion C7 Dragonfly imaging catheter.
The devices create a 50-millimeter coronary scan in under three seconds without vessel occlusion, according to a press release, and provide resolution at 15 micrometers, roughly twice the size of a red blood cell.
The devices have also been approved for use in 35 other countries.
The Westford, Mass.-based medical device company is a manufacturer and marketer of optical coherence tomography for vascular and other imaging applications.