COLORADO SPRINGS, Colo., The Spectranetics Corporation today announced U.S. Food and Drug Administration (FDA) Premarket Notification 510(k) submission of the Bridge Occlusion Balloon. Building on the ...
The Spectranetics Corp. said it received clearance of its bridge occlusion balloon for temporary vessel occlusion in cardiac lead extraction procedures. The Colorado Springs, Colorado-based company ...
The U.S. FDA’s final guidance for clinical decision support (CDS) systems may be the subject of two citizen’s petitions requesting the agency scrap the guidance ...
Medical device manufacturer Spectranetics Corp. of Colorado Springs is being sold for $2.2 billion to Dutch health electronics giant Royal Philips in the largest deal ever involving a local company.