FDA Approves Boston Scientific’s MRI System

Boston Scientific has scored FDA approval for its ImageReady MR-Conditional pacing system for treating bradycardia.

The approval, which was based on two global clinical trials, covers the ACCOLADE MRI and ESSENTIO MRI pacemakers and INGEVITY MRI pacing leads.

This marks the first time a passive fixation pacing lead has been approved in the U.S. for patients undergoing MR scans, according to the company. — Anisa Jibrell