Devices & Diagnostics

FDA panel approves Medtronic MRI-friendly pacemaker

A special panel of experts convened by the Food and Drug Administration has unanimously recommended the agency approve a MRI-friendly pacemaker developed by Medtronic Inc., a company spokesperson has confirmed. The panel voted 15-0 to green light the company’s REVO Surescan pacemaker. The decision is not binding but the agency almost always follows the panel’s […]

A special panel of experts convened by the Food and Drug Administration has unanimously recommended the agency approve a MRI-friendly pacemaker developed by Medtronic Inc., a company spokesperson has confirmed.

The panel voted 15-0 to green light the company’s REVO Surescan pacemaker. The decision is not binding but the agency almost always follows the panel’s recommendation.

Spokesman Chris Garland said the company hopes the FDA will formally approve the device between May and October this year, or the first half of the company’s fiscal 2011.