Spectral receives ISO 13485 certification for AI-driven DeepView Wound Imaging

Spectral MD 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 indications. 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.” As announced on April 11, 2023, Spectral MD Holdings has entered into a business combination agreement to combine with Rosecliff Acquisition Corp I, a special purpose acquisition company listed on Nasdaq.