Lizzy's Device Digest
FDA clears AI skin cancer detection device
The Food and Drug Administration cleared an AI-powered device for detecting skin cancer on Wednesday, giving primary care physicians a new way to evaluate troubling skin spots, STAT's Lizzy Lawrence reports.
The device, developed by a small company called DermaSensor, is handheld and uses light to examine suspicious moles on a cellular level. It will be marketed specifically for primary care physicians to use in routine check-ups in patients aged 40 and above. After scanning a mole and running the image through its algorithm, the device presents the doctor with a score between zero and 10: zero means "monitor," and any number between 1 and 10 means "investigate further." The higher the number, the greater the chance that the mole is malignant.
Though the device searches for melanoma, basal cell carcinoma, and squamous cell carcinoma, it does not give a black-and-white diagnosis. DermaSensor will not specify the cancer, or help determine treatment. But it might help primary doctors catch more cancers earlier. The goal is to help doctors decide whether to order more invasive tests.
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digital therapeutics
DTx companies try new business models
Over the last year, the business challenges facing digital therapeutics companies have become absolutely clear. Software-based medicines might one day be mainstream, but the health care system isn't going to move quickly to embrace — or pay for — the novel products right now.
Faced with roadblocks, many companies have made strategic pivots designed to help them build sustainable business models that will work in the short term, whether or not the insurance industry writ large decides to play ball. In my new story, I unpack the details and thinking behind how three companies changed direction.
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