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TomoTherapy says FDA OKs radiation technology



By AP
27 August 2008 @ 03:28 pm EST

MADISON, Wis. - TomoTherapy Inc. said the Food and Drug Administration has approved its TomoDirect technology, which modifies its Hi-Art radiation therapy system.

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The agency granted FDA 510(k) clearance for TomoDirect late Tuesday. TomoTherapy plans to unveil the technology at industry meetings in September.

The Hi-Art machines spiral around a patient to deliver direct doses of radiation to treat cancer. TomoDirect allows the radiation treatments to follow a straight-line path rather than a spiral if physicians choose.

A 510(k) is a submission made to the FDA showing that a medical device under development is as safe and effective as a legally marketed product, and isn't subject to premarket approval.

In afternoon trading, TomoTherapy shares climbed 45 cents, or 8.1 percent, to $5.98.

Copyright 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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