FDA Clearance of Disposable MR-Conditional Cup Electrodes A “First”

The U.S. FDA has cleared for marketing Rhythmlink’s Disposable MR Conditional Cup Electrodes, the first of a kind to be formally authorized for use.

Background

Rhythmlink International, LLC designs, manufactures and distributes a variety of accessories for intraoperative neuromonitoring, electroencephalography, evoked potentials and polysomnography.

Methodically tested in specific MRI scenarios, Rhythmlink’s Disposable MR Conditional Cup Electrodes can safely remain on a patient during a MR scan in static magnetic fields of 1.5 or 3.0 Tesla without causing undue image artifact.

Company comments

“Significant resources went into developing this technology,” commented CEO Shawn Regan. “This is a special milestone for us. What our team has accomplished is very impressive. We’ll be able to help many, many lives for years to come.”

“Our new Disposable MR Conditional EEG Electrodes directly impact patient care. This product will eliminate the need to remove and reapply EEG electrodes each time a patient requires imaging. Many patients need frequent imaging during critical points of their care to assist with brain assessments and management,” stated Director of Sales Leah Hanson. “Eliminating the step of removal/reapplication reduces the risk of skin injury that can occur during the application process which can lead to other complications such as infections.”

Source: Rhythmlink International, Business Wire