US FDA Grants Breakthrough Device Designation to Marpe's Dermatology Screening System

The Marpe System is designed to acquire and analyze total body images to support the identification of malignant and pre-malignant lesions, with a particular focus on melanoma in adults.

The US Food and Drug Administration (FDA) has granted Breakthrough Device designation to Marpe Technologies full-body Dermatology Screening System.

The Marpe System is designed to acquire and analyze total body images to support the identification of malignant and pre-malignant lesions, with a particular focus on melanoma in adults. The system records all lesions and acquires dermoscopic views on suspicious lesions, providing clinicians with comprehensive information for review, comparison to previous scans, and referral to biopsy for diagnosis. The system also stores all images for future comparisons.

The Breakthrough Device designation will facilitate a streamlined regulatory review process.

"We believe that Marpe's Dermatology Screening System has the potential to revolutionize the way dermatological conditions are detected and treated," says Yaakov Navon, CTO of Marpe Technologies, in a news release. "With the FDA's support, we are one step closer to making this cutting-edge technology accessible to patients and healthcare providers worldwide."