Biofield plans premarket approval application (PMA) later this year:
This article was originally published in Clinica
Biofield says it plans to submit a PMA for its breast cancer diagnostic system with the US FDA later this year. Enrollment of a double-blinded study was completed earlier this year. In preparation for the device's European launch in 1997, Biofield has set up a marketing division headed by Lee Cohen who will have responsibility for both European and US marketing. Biofield, which raised $19 million in its IPO in March, has developed a non-invasive system which measures cellular electrical charge distributions associated with epithelial cancers (see Clinica No 714, p 13).
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