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Biofield to resubmit breast device PMA

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After more than a year of reevaluation, medical technology company Biofield has fine-tuned its Biofield Breast Cancer Diagnostic System and is preparing to resubmit its premarket approval (PMA) application upon completion of a second round of clinical

After more than a year of reevaluation, medical technology company Biofield has fine-tuned its Biofield Breast Cancer Diagnostic System and is preparing to resubmit its premarket approval (PMA) application upon completion of a second round of clinical trials.

The Roswell, GA, company submitted its first PMA for the noninvasive breast cancer diagnosis device in 1996, when the system was called Alexa 1000. In 1997, the Food and Drug Administration informed Biofield that its PMA was not fileable, citing design weaknesses in the clinical trials, particularly in the algorithms chosen for use on the data set supporting the application (SCAN 6/11/97).

Since receiving the FDA’s letter, the company has reevaluated the device’s design, strengthening its software. Biofield has also been in negotiation with the FDA over the parameters of a second set of multicenter clinical trials. Like the firm’s initial PMA, the second one will be processed by the FDA under expedited review. Biofield hopes Biofield Breast Cancer Diagnostic System will be cleared by late 1999 or early 2000.

Biofield Breast Cancer Diagnostic System does not produce images, but instead reads electrical signals generated by the body, detecting cellular electrical charge distributions associated with breast cancer, according to the company. The system uses disposable sensors that are hooked to a recording device much like an electrocardiograph. Test results are produced in the form of number of millivolts rather than rhythm data, with higher numbers indicating likelihood of malignant tissue. The device received CE Mark certification in June.

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