AI solution for skin cancer receives 2 FDA Breakthrough Device designations

3Derm Systems, a Boston-based skin imaging and diagnostics company, has received two FDA Breakthrough Device designations for its 3DermSpot AI solution.

3DermSpot uses AI technology to automatically detect melanoma, squamous cell carcinoma and basal cell carcinoma in skin images. 3Derm developed the algorithm through collaborations with primary care physicians and dermatologists across the United States.

“We're operating in a field with a lot of snake oil,” Liz Asai, CEO and co-founder of 3Derm, said in a prepared statement. “To get this right, we must hold ourselves to a higher clinical standard and continuously incorporate the perspectives of patients, providers, and regulators. We are thrilled to receive these Breakthrough designations and to have additional support in our ongoing regulatory discussions.”

“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,” dermatologist Arash Mostaghimi, MD, an advisor to 3Derm, said in the same statement. “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.”