FDA Clears Damae Medical’s deepLive Skin Imager

FDA has cleared a Damae Medical 510(k) for its deepLive, described by the company as an artificial intelligence-based imaging tool that provides real-time, three-dimensional visualization of the skin. The clearance is based on data from three years of clinical experience with the device and its intuitive interface. The device accesses an image, makes a diagnosis and suggests some type of therapeutic treatment regimen, if needed, the company says. It is designed for dermatology practices and private skin cancer clinics.

Damae Medical says it has integrated advanced line-field confocal optical coherence tomography imaging and AI into its deepLive device. It has been “validated by over 240 clinical studies,” which has proven its “accuracy for the diagnosis of basal cell carcinoma (96%) and other conditions such as melanoma, actinic keratoses, and squamous cell carcinomas,” it adds.