Re: USA approval for Verisante Aura ???
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Breakthrough Early Stage Cancer Detection System
Message: Health Canada Approval for Verisante Aura...
MelaFind underwent a contentious, years-longreview 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 givephysicians a false sense of certainty, leading to fewer biopsies.Another concern was that doctors could misinterpret the device'sfeedback, particularly error messages when a mole cannot be scanned.About 8 percent of growths scanned in thecompany study came back as "unevaluable."
MelaFind correctly identified about 10 percent of non-cancerousgrowths, which was better than doctors in the study who were correctless than 4 percent of the time, on average. The study was published inthe Archives of Dermatology.
he device's handheld attachment,about the size of a blow dryer, emits light that penetrates below thesurface of the skin, taking multicolored images that reflect the depthand shape of skin growths. Acomputer 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
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