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Home » Medtronic lands 510(k) for next-gen Polestar surgical MRI device

Medtronic lands 510(k) for next-gen Polestar surgical MRI device

April 26, 2010 By MassDevice staff

MedCity News logo

By Brandon Glenn

Medtronic Inc. (NYSE:MDT) won 510(k) clearance from the Food & Drug Administration for a next-generation version of an imaging system used by brain surgeons.

The company’s Polestar N30 Surgical MRI system is designed to help surgeons navigate when parts of the brain shift during operations, according to a press release. Medtronic claims that the device may reduce the need for follow-up surgeries and the length of hospital stays.

More than 50 units of the previous version of the Polestar system have been installed in operating rooms worldwide since 2001. The new version has a smaller scanner that’s easier to fit in operating rooms, the company said.

Medtronic’s third-quarter results included “strong U.S. sales” of its navigation equipment. Revenues in its surgical technologies business grew 15 percent to $239 million for the quarter.

Filed Under: Business/Financial News, Neurological, News Well

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