Sicel Technologies Receives 510(k) Clearance For DVS(R), The First Implantable Radiation Sensor For Use In Treating Cancer

RALEIGH, N.C.--(BUSINESS WIRE)--April 12, 2006--Sicel Technologies, Inc., announced today that DVS® (Dose Verification System), its wireless, implantable radiation sensor and reader has received 510(k) clearance from the U.S. FDA. FDA clearance was based upon successful completion of a multi-center clinical study of breast cancer patients most of who were implanted with two DVS® sensors prior to receiving radiation therapy. Using the hand held reader, physicians were able to determine the actual dose of radiation being delivered to the tumor after each course of therapy. Implantation of the DVS® sensor did not lead to any adverse events in the clinical trial.
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