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FDA OKs TomoTherapy's new radiation therapy technology
Madison-based TomoTherapy Inc. announced Tuesday that the U.S. Food and Drug Administration has approved its "TomoDirect" technology, which modifies its Hi-Art radiation therapy system.
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.
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