AI FDA Imaging

3Derm lands FDA breakthrough device designations for autonomous skin cancer AI

3Derm Systems announced that it won two FDA breakthrough device designations for its 3DermSpot autonomous artificial intelligence imaging system for detecting skin cancer.

The 3DermSpot is an algorithm designed to use AI and highly standardized skin images to autonomously detect melanoma, squamous cell carcinoma and basal cell carcinoma.

Autonomous AI has the potential to provide a recommendation for suspicious lesions that does not require interpretation, 3Derm Systems said in a news release. The 3DermSpot is designed to offer primary care providers the triage options of referring a patient for potential skin cancer or watchful waiting for a benign concern.

Boston-based 3Derm Systems touts it as the first autonomous AI device in the dermatology space to receive breakthrough designation, and just the second autonomous AI device in all spaces to do so. The company said FDA approval would make 3DermSpot the first device to bring dermatologist-level triage to primary care.

3Derm Systems said it is continuing to develop platforms to expand dermatological care for skin lesions and other inflammatory diseases.

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