Spectral MD Holdings, Ltd. (AIM: SMD), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, announces that it has received ISO 13485 certification for the manufacture and distribution of its AI-driven DeepView® Wound Imaging System which is designed to provide immediate, accurate, and binary wound treatment assessments for Burn and Diabetic Foot Ulcer (DFU) indications.
ISO 13485 is an internationally recognized standard that ensures the quality of medical device design, development, and production. To receive certification, organizations must demonstrate that their Quality Management Systems (QMS) deliver medical devices and related services that consistently meet stringent customer and regulatory requirements. Spectral MD’s receipt of ISO 13485 certification follows the completion of a comprehensive audit of the Company’s QMS undertaken by an Independent Registrar earlier this year.
Niko Pagoulatos, Chief Operating Officer of Spectral MD, said: “The receipt of ISO 13485 confirms Spectral MD’s status as a global provider of medical devices that meet the highest standards of quality, reliability, and safety. We believe that this acknowledgement reflects Spectral MD’s commitment to fostering a culture of continuous improvement, validates the robust sourcing and operational framework we have created, and provides an important competitive advantage as we continue our regulatory submission initiatives and advance towards product commercialization.”
Spectral MD’s DeepView Wound Imaging System - which received Breakthrough Device Designation from the U.S. Food and Drug Administration (“U.S. FDA”) in 2018 for its Burn indication – integrates optical technology and AI-enabled algorithms using a proprietary database of over 263 billion clinically-validated data points to see deep below the skin’s surface to distinguish between healthy and damaged tissue. The DeepView platform is designed to address a large unmet clinical need by delivering an immediate, informed, and binary AI-driven wound healing assessment that assists physicians in determining whether a burn will heal on its own or if surgery is required.
Source: https://www.spectralmd.com/