FDA grants breakthrough device designation to AI-powered, diagnostic skin cancer tool

Key takeaways:

• Enspectra Health's VIO Skin Platform is a device that can classify suspicious lesions into non-melanoma skin cancer subtypes.
• This device can be used in select high-risk populations.

The FDA has granted breakthrough device designation to VIO Skin Platform, an AI-powered tool that evaluates suspicious lesions for skin cancer, Enspectra Health announced in a press release.

VIO Skin Platform (Enspectra Health) can classify lesions as basal cell carcinoma or squamous cell carcinoma, the most common forms of nonmelanoma skin cancer, in select high-risk populations, thereby aiding physicians in their clinical decision-making.

“Attaining breakthrough designation for our next generation technology underscores the need for a noninvasive assessment option in nonmelanoma skin cancer,” Gabriel Sanchez, PhD, CEO and co-founder of Enspectra Health. “We are honored to work closely with the FDA to bring advanced AI [and machine learning] tools to dermatology for better patient care.”

Like other devices, the VIO Skin Platform received the breakthrough device designation for its potential to provide more effective diagnosis and treatment assistance for a life-threatening disease.