> On January 17, 2024, the US Food and Drug Administration (FDA) announced it had __cleared DermaSensor[0]__ as the first AI-powered medical device able to...
From [0] (emphasis my own)
> On Friday, the FDA authorized __for marketing__ the DermaSensor Inc. DermaSensor device. It is a prescription device, indicated for the evaluation of skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged 40 and over to assist health care providers in determining whether to refer a patient to a dermatologist. __The device should be used in conjunction with the totality of clinically relevant information from the clinical assessment, including visual analysis of the lesion, by physicians who are not dermatologists.__ __The device should be used on lesions already assessed as suspicious for skin cancer and not as a screening tool.__ __The device ,,SHOULD NOT,, be used as the ,,sole,, diagnostic criterion nor to confirm a diagnosis of skin cancer.__ The FDA is requiring that the manufacturer conduct additional post-market clinical validation performance testing of the DermaSensor device in patients from demographic groups representative of the U.S. population, including populations who had limited representation of melanomas in the premarket studies, due to their having a relatively low incidence of the disease.
Even the product's website specifically says "clearer"[1]. And Reuter's article from 2 days ago[2]
@dang, I think this merits at minimum a title change but probably a link change. Current link is misleading and appears to be much more marketing focused.
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?
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.
> On January 17, 2024, the US Food and Drug Administration (FDA) announced it had __cleared DermaSensor[0]__ as the first AI-powered medical device able to...
From [0] (emphasis my own)
> On Friday, the FDA authorized __for marketing__ the DermaSensor Inc. DermaSensor device. It is a prescription device, indicated for the evaluation of skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged 40 and over to assist health care providers in determining whether to refer a patient to a dermatologist. __The device should be used in conjunction with the totality of clinically relevant information from the clinical assessment, including visual analysis of the lesion, by physicians who are not dermatologists.__ __The device should be used on lesions already assessed as suspicious for skin cancer and not as a screening tool.__ __The device ,,SHOULD NOT,, be used as the ,,sole,, diagnostic criterion nor to confirm a diagnosis of skin cancer.__ The FDA is requiring that the manufacturer conduct additional post-market clinical validation performance testing of the DermaSensor device in patients from demographic groups representative of the U.S. population, including populations who had limited representation of melanomas in the premarket studies, due to their having a relatively low incidence of the disease.
Even the product's website specifically says "clearer"[1]. And Reuter's article from 2 days ago[2]
@dang, I think this merits at minimum a title change but probably a link change. Current link is misleading and appears to be much more marketing focused.
[0] https://www.fda.gov/news-events/press-announcements/fda-roun...
[1] https://www.dermasensor.com/
[2] https://www.reuters.com/business/healthcare-pharmaceuticals/...