FDA gives nod to market Rhythmlink’s Disposable MR Conditional Cup Electrodes

The US Food and Drug Administration (FDA) has given its nod to market Rhythmlink's Disposable MR Conditional Cup Electrodes in the US.

FDA approval makes Disposable MR Conditional Cup Electrodes, which have been in development since many years, the first of its kind products to get authorization for use.

Rhythmlink CEO Shawn Regan said, "Significant resources went into developing this technology."

The electrodes are methodically tested in the MRI scenarios and are found to remain safe on a patient during an MR scan in static magnetic fields of 1.5 or 3.0 Tesla without causing undue image artifact.

Rhythmlink Sales director Leah Hanson said the company’s new electrodes 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," Hanson added.

"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".