FDA clears Boston Scientific endoscopic catheter

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Boston Scientific has received 510(k) clearance from the FDA to market its SpyScope Access and Delivery catheter for diagnostic and therapeutic applications during endoscopic procedures of the pancreatico-biliary system.

The SpyScope catheter is used in conjunction with the SpyGlass Direct Visualization system, according to the Natick, Mass.-based company.

Previously available for use in the bile and hepatic ducts, the SpyGlass system can now be used to guide visualization and accessory devices throughout the pancreatico-biliary system, allow physicians to diagnose and treat pancreatic cancer or pre-cancerous tissues, Boston Scientific said.