[AlphaOne1]

I also thing the marketing release contradicts the terms of the cleared status by the FDA. The FDA specifically says this is not for screening or diagnosis. So essentially what does this device actually help with? A physician needs to be suspecting something abnormal with a lesion before using. If it is "negative" would a physician really want to trust a device in the off chance it misses a melanoma? If I were a family doctor and was suspicious of a lesion enough to use this device, wouldn't it make more sense to send to derm or just go ahead an biopsy?

[oezi]

An aid to diagnosis is quite typical if the sensitivity of the device is considered too low.

[ealexhudson]

It's not even that: it's a device for non-dermatologists, to decide if they need to make a referral. "Cleared" is definitely the right language here, this might only be a Class 1 medical device, it's not making any diagnostic claims.