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Home Industry News Medtronic receives FDA clearance for Reveal DX and XT

Medtronic receives FDA clearance for Reveal DX and XT

14th December 2007

Medtronic has announced that the US Food and Drug Administration (FDA) has given clearance for its new insertable cardiac monitors – the Reveal DX and Reveal XT.

The devices have been approved to provide diagnostic and monitoring facilities to cardiologists supporting patients with syncope (fainting) or abnormal heart rhythms.

Medtronic has confirmed that following the FDA decision, the Reveal DX will be commercially available in the US by next week and the Reveal XT will shortly follow.

The devices expand on the cardiac monitoring foundation Medtronic launched over a decade ago with the Reveal and Reveal Plus Insertable Loop Recorders.

Pat Mackin, president of the Cardiac Rhythm Disease Management business, said that the Reveal DX showcased Medtronic’s commitment to meeting the needs of patients with previously unidentified arrhythmias.

“These patients often have their lives and activities curtailed because of unexplained fainting episodes. The Reveal monitors provide diagnostics and monitoring that can offer physicians a view into their patients’ conditions even when they’re not present,” he indicated.

The Reveal DX continuously monitors the heart’s electrical activity and can help health professionals diagnose whether symptoms such as fainting and dizziness have a cardiovascular cause.

Earlier this month, Medtronic announced that it had filed the final module of its Pre-Market Approval application with the FDA for the Talent Abdominal Stent Graft System.

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