Biotronik gets FDA nod for Entovis

Biomedical device company Biotronik has received U.S. Food and Drug Administration (FDA) approval for its Entovis pacemaker system with ProMRI technology.

Entovis enables patients to undergo MRI with a limited exclusion zone, according to the vendor. The FDA approval covers both single chamber (SR-T) and dual chamber (DR-T) Entovis pacemakers when implanted with Setrox pacing leads, Biotronik said.