CAESAREA, ISRAEL / ACCESSWIRE / July 31, 2023 / Marpe Technologies, a leading innovator in dermatology screening solutions, is thrilled to announce that its groundbreaking full-body Dermatology Screening System has been granted Breakthrough Device designation by the Food and Drug Administration (FDA). The prestigious designation comes after the FDA reviewed and approved Marpe's combination product and proposed indication for use.
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 adult patients. 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.
"We are truly honored and excited to receive FDA's Breakthrough Device designation," said Tovi Bechar, CEO of Marpe Technologies. "This recognition is a testament to the tireless efforts of our dedicated team and the potential impact of our innovative Dermatology Screening System in advancing the field of dermatology."
The Breakthrough Device designation signifies the FDA's acknowledgment of Marpe's technology as a significant advancement in the early diagnosis and treatment of skin conditions. This recognition will facilitate a streamlined regulatory review process, enabling Marpe to expedite the development and commercialization of its revolutionary product.
"We believe that Marpe's Dermatology Screening System has the potential to revolutionize the way dermatological conditions are detected and treated," added Yaakov Navon, CTO of Marpe Technologies. "With the FDA's support, we are one step closer to making this cutting-edge technology accessible to patients and healthcare providers worldwide."
Marpe Technologies extends its gratitude to the FDA for this significant achievement and looks forward to continuing its mission of delivering innovative solutions that improve patient outcomes and transform dermatology care.
For more information about Marpe Technologies and its Dermatology Screening System, please visit MarpeTech.com.
About Marpe Technologies:
Marpe Technologies is a leading medical technology company dedicated to revolutionizing dermatology care. Its state-of-the-art Dermatology Screening System leverages Technology Aided Dermatology (TAD) and AI-CAD based solutions to enhance early detection and prevention of skin conditions, focusing on the identification of malignant melanoma and suspicious nevus/moles.
Contact:
Anat Kaphan
Marpe Media Relations
Email: [email protected]
SOURCE: Marpe Technologies