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TomoTherapy Gets FDA Approval For TomoDirect Radiation Therapy Technology |
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August 28, 2008 (FinancialWire) The Food and Drug Administration has approved TomoTherapy Inc. s (NASDAQ: TOMO) TomoDirect technology, which modifies its Hi-Art radiation therapy system. The agency granted FDA 510(k) clearance for TomoDirect and the company 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. Shares of TomoTherapy rose 25 cents to close at $5.78 Wednesday. FinancialWire is a fully independent, proprietary news wire service of Investrend Information (a division of Investrend Communications, Inc.). FinancialWire news is written by professional journalists, dedicated to pure journalistic standards. FinancialWire does not receive or accept any compensation from any individual or subject company (or representative thereof) for its news or opinions. All FinancialWire news is available at http://www.financialwire.net . Please address any inquiries to feedback@financialwire.net . Free annual reports for companies mentioned in the news are available at http://investrend.ar.wilink.com/?level=279 .
(Distributed for Investrend Communications, Inc. via M2 Communications Ltd (www.m2.com)) .END
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(C)2008 Investrend Communications, Inc. |
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