Verisante Technology Inc (VRS.H)

[CansoSpaceMan]

MelaFind underwent a contentious, years-long review by the Food and Drug Administration, which initially rejected the device and concluded it could "potentially cause more harm than good."

Regulators worried that the device could give physicians a false sense of certainty, leading to fewer biopsies. Another concern was that doctors could misinterpret the device's feedback, particularly error messages when a mole cannot be scanned. About 8 percent of growths scanned in the company study came back as "unevaluable."

MelaFind correctly identified about 10 percent of non-cancerous growths, which was better than doctors in the study who were correct less than 4 percent of the time, on average. The study was published in the Archives of Dermatology.

he device's handheld attachment, about the size of a blow dryer, emits light that penetrates below the surface of the skin, taking multicolored images that reflect the depth and shape of skin growths. A computer compares these to a database of 10,000 archived images and recommends whether a biopsy should be done.

http://seattletimes.nwsource.com/html/health/2016712485_apusskincancerscreeningdevice.html