MADISON, Wis. - TomoTherapy Inc. said the Food and Drug Administration has approved its TomoDirect technology, which modifies its Hi-Art radiation therapy system.
| TOMO | 2.67 |
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.
U.S. stocks were mixed on Thursday after retailers reported mostly disappointing sales while other big-name companies announced layoffs and Europ...
China markets opened lower on Tuesday morning as the investors' confidence hit by the signals that global recession are deepening.
The markets have spoken: risk aversion is still the name of the game and that was obvious since the beginning of the week.


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