3Derm Announces Two FDA Breakthrough Device Designations for Autonomous Skin Cancer AI

3Derm Systems has been granted two FDA Breakthrough Device designations for 3DermSpot, an algorithm that uses artificial intelligence (AI) and highly standardized skin images to autonomously detect melanoma, squamous cell carcinoma, and basal cell carcinoma. 3Derm demonstrated its potential to provide a more effective diagnosis for life-threatening and irreversibly debilitating diseases to qualify for this fast-track program. 3DermSpot is the first autonomous AI device in the dermatology space to receive Breakthrough designation, joining only one other autonomous AI device. If ultimately approved by the FDA, 3DermSpot will be the first to bring dermatologist-level triage to primary care.

Primary care providers are often the first to examine patients' skin concerns, referring suspicious lesions if a dermatologist is accessible. 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. 3DermSpot gives providers one of two actionable triage decisions: refer the patient for a potential skin cancer or watchful waiting for a benign concern.

3Derm has been developing 3DermSpot in collaboration with primary care physicians and dermatologists across the country, including Arash Mostaghimi, MD, a board-certified dermatologist and advisor to 3Derm.

"Development of accurate, easy to use AI products to support primary care physicians can provide high-quality care for millions of Americans with limited access to dermatology," said Dr. Mostaghimi. "This is an incredible milestone for a great team that has a unique understanding of both the clinical and technical challenges of the task at hand."

Skin cancer is the most common cancer in the United States, with over five million cases diagnosed each year. There are critical windows for timely diagnosis of these cancers that can impact both mortality and morbidity, yet a nationwide shortage of dermatologists has led to increased wait times and delays in diagnosis and treatment.

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