Hansen Medical (NSDQ:HNSN) said it launched the 3rd generation of its Sensei robot-assisted surgery platform, the Sensei X2, after winning regulatory nods in Europe and the U.S.

Hansen said the FDA OK’d Sensei X2 for use in electrophysiology procedures to map the heart’s electrical impulses, using mapping catheters made by Boston Scientific (NYSE:BSX) and St. Jude Medical (NYSE:STJ), but does not cover the use of cardiac ablation catheters.

The indication for CE Mark approval in the European Union covers "manipulation, precise positioning and control of percutaneous catheters within the atria of the heart," according to a press release.

"Sensei X2 incorporates insights from years of technical and clinical experience with the Sensei Robotic System in electrophysiology procedures," COO Will Sutton said in a statement. "With the growing body of evidence in over 26 clinical studies, we believe Sensei X2 will continue to aid electrophysiologists in improving patient outcomes."

“The introduction of the Sensei X2 robotic system to the U.S. and European markets demonstrates Hansen’s commitment to electrophysiology,” added president & CEO Cary Vance. “The advancements with Sensei X2 represent Hansen’s ability to continually deliver on a robust, new product pipeline.”