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Medtronic gets FDA CardioSight approval

MINNEAPOLIS (AP) - Medtronic Inc. said Wednesday that the Food and Drug Administration cleared the medical device maker's CardioSight Service data access tool for patients implanted with the company's heart devices.

The tool reads data from an implanted device, such as defibrillator or a defibrillator with pacing functions, using a computer-mouse sized antenna.

With the CardioSight, doctors can monitor to see whether a heart failure patient's symptoms are stable or deteriorating. The device can download 90 days worth of data and report any of this information over a fax machine within minutes. Medtronic said the CardioSight is particularly helpful for doctors who did not implant the original device.

The CardioSight can also measure fluid levels in a patient's chest cavity and lungs, an indicator of heart disease.

In late February, the company initiated a recall of nearly 2,000 defibrillators saying the devices may fail to analyze heart rhythm, preventing it from resuscitating a patient. The recall of the LifePak 500 automated external defibrillators represented 1 percent of Lifepack 500 defibrillators currently in use worldwide, Medtronic said.

Medtronic shares rose 23 cents to $54.88 in afternoon trading on the New York Stock Exchange.

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