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SenoRx Uses Implantable RFID Tags to Mark Breast Tumors
The company's system would allow radiologists to inject a passive RFID tag into a patient's breast, to help a surgeon locate a lesion during a lumpectomy.
Health Beacons first approached SenoRx with the RFID interrogator and tag in August 2008. The system involves an implantable tag approximately the size and shape of a grain of rice, as well an injector to implant the tag, and a handheld reader provided by Health Beacons. The tag consists of an 134.2 kHz RFID inlay encased in glass and complying with the ISO 11784 and 11785 standards, and its glass exterior is surrounded by a steel coil, each end of which forms a hook. The purpose of the coil and hooks is to help prevent the tag from migrating within the body.
While examining a lesion, a radiologist would use an injector to insert a tag, in the center of the tumor or inject a tag on each side of it to form a bracket around it. The patient could then go home and proceed to schedule surgery within the following week. Prior to cutting an incision, the surgeon uses a pencil-like probe wired to the RFID reader (with an antenna in the probe), in order to detect the tag. Once the probe comes within 3 centimeters (1.2 inches) of the tag, the interrogator emits a sound to indicate it is within range. The distance between the tag and reader is determined by the strength of the tag's emitted signal, which becomes louder (accompanied by a light flashing on the interrogator) as it gets closer. The reader screen lists that tag's unique ID number as well. After the lesion is excised, all tags are removed as well and are disposed of.
RFID may make the identification of a tumor more accurate than the traditional wire method, Lubock says, though the technology has not yet been tested for the degree of accuracy against that standard technique. Thus far, the device has been tested for accurate reads on cadaver and other tissues prior to the FDA 510(k) application. The convenience of reducing infection risks, and thus allowing more time between the scheduling of the radiology procedure and surgery, may be what will interest the health-care industry most. "That's the most compelling aspect of the solution," he states.
According to Lubock, once the system receives approval from the FDA and has gone through clinical trials, it may be initially provided to a limited number of health-care facilities. "We walk before we run," he says, indicating that SenoRx intends to market the product only after it has been through rigorous testing and possibly modified, based on feedback from pilot participants.
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