Hansen nets FDA 510(k) clearance

Robotic technology developer Hansen Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Magellan robotic system for use in peripheral vascular interventions.

The system, which received European approval in 2011, allows physicians to be seated away from the radiation source during procedures and prevents them from standing for long periods of time, the firm said.

Magellan facilitates navigation to anatomical targets in the peripheral vascular system and provides a conduit for the manual placement of therapeutic catheters, Hansen said.

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