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www.fdanews.com/articles/213156-dermasensors-hand-held-skin-cancer-evaluation-system-cleared-by-fda

DermaSensor’s Hand-Held Skin Cancer Evaluation System Cleared by FDA

January 24, 2024

A hand-held device proven successful in evaluating lesions will be available to primary care physicians following the FDA’s green light clearance of DermaSensor’s skin cancer evaluation system.

Recordings of a suspicious skin lesion would be sent through an AI-powered algorithm and deliver an immediate result, making the device an accelerated option to potentially identify skin cancer and prioritize a referral.

“While dozens of companies have attempted to address this problem in recent decades, we are honored to be the first device cleared by the FDA that provides PCPs with an automated tool for evaluation of suspicious lesions,” said DermaSensor CEO Cody Simmons. The company says the device has demonstrated the ability to cut the number of missed skin cancers in half (18 to 9 percent).

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