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.
