SenoRx Expands Breast Cancer Business Beyond Biopsies To Disease Therapy
This article was originally published in The Gray Sheet
Executive Summary
SenoRx plans to submit a 510(k) application to FDA in the second half of this year for its Radiation Balloon catheter system for breast cancer treatment
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SenoRx breast cancer radiation balloon
Firm will delay until early 2008 a full launch of its multi-lumen Radiation Balloon breast cancer brachytherapy device following 510(k) clearance, announced May 23. SenoRx plans clinical trials to support marketing claims prior to its debut. The minimally invasive device uses a vacuum to remove excess fluid and keep the balloon adhered to irregularly shaped lumpectomy cavities, and its multiple radiation seed lumens enable precise radiation dosing, SenoRx explains. The Aliso Viejo, Calif. company went public in March (1"The Gray Sheet" April 9, 2007, p. 8)...
SenoRx breast cancer radiation balloon
Firm will delay until early 2008 a full launch of its multi-lumen Radiation Balloon breast cancer brachytherapy device following 510(k) clearance, announced May 23. SenoRx plans clinical trials to support marketing claims prior to its debut. The minimally invasive device uses a vacuum to remove excess fluid and keep the balloon adhered to irregularly shaped lumpectomy cavities, and its multiple radiation seed lumens enable precise radiation dosing, SenoRx explains. The Aliso Viejo, Calif. company went public in March (1"The Gray Sheet" April 9, 2007, p. 8)...
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