Skin Analytics Gains Smartphone Certification for DERM Zero AI Skin Cancer Tool

Skin Analytics has received Class III medical device certification for its DERM Zero platform, enabling autonomous clinical grade skin cancer assessments from a standard smartphone, according to a press release.

DERM Zero uses the same regulated AI that has been deployed across NHS skin cancer pathways for six years. The DERM platform is active in 24 NHS hospitals, where it has assessed more than 230,000 patients and detected over 20,000 cancers. The new certification allows DERM Zero to deliver the same autonomous diagnostic decisions without requiring specialist equipment or hospital appointments.

Unlike existing skin check applications, DERM Zero can provide a definitive assessment directly to healthcare providers. Lesions identified as non-concerning are marked as such, while suspicious ones are flagged for further medical evaluation. This marks the first time a smartphone-compatible solution has been CE marked to Class III, the highest level of medical device classification within the European Union.

Skin Analytics stated that the certification extends the reach of its proven clinical technology, allowing primary care and community settings to perform dermatologist-level assessments in seconds using only a smartphone.