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# 3Derm Systems ‘Breakthrough’ for Skin Cancer AI
- URL: https://www.fdaweb.com/3derm-systems-breakthrough-for-skin-cancer-ai/
- Published: 2020-01-08T12:00:00.000Z
- Updated: 2026-09-14T15:57:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145795

FDA has granted 3Derm Systems a breakthrough device designation for its 3DermSpot, an algorithm that uses artificial intelligence (AI) and highly standardized skin images to autonomously detect melanoma, squamous cell carcinoma, and basal cell carcinoma. If approved by FDA, the device will be the first to bring dermatologist-level triage to primary care, the company says.

Primary care providers are often the first to examine patients’ skin concerns, referring suspicious lesions to a dermatologist. “While many tools and educational initiatives have been developed to assist in making these referral decisions, autonomous AI has the potential to provide a recommendation that does not require interpretation,” the company says. “3DermSpot gives providers one of two actionable triage decisions: refer the patient for a potential skin cancer or watchful waiting for a benign concern.”