DermaSensor cancer detection device receives breakthrough device designation
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The FDA has granted breakthrough device designation to DermaSensor for its skin cancer detection device, the company announced in a press release.
The DermaSensor device takes spectroscopic recordings, emitting light and capturing the wavelengths that scatter off cellular structures. A proprietary machine learning algorithm then analyzes the light to give a result.
“DermaSensor’s ability to analyze and provide feedback on cellular substructure, which is invisible to the human eye even when aided by a dermatoscope, and to accomplish this in seconds, will empower health care providers at the important moment of patient assessment and medical decision-making,” Jeanett Segal, MD, DermaSensor’s global senior medical director, said in the release. “Putting an early skin cancer detection tool in the hands of primary care providers means that we are better connecting the clinical front line with specialists and giving them greater information and a measurable means of assessing likelihood of a skin cancer.”
The DermaSensor device has a CE mark and is available in Australia and New Zealand.