By Anthony O. Goriainoff
Spectral MD Holdings said it has been granted ISO medical devices certification for the manufacture and distribution of its AI-driven DeepView wound imaging system.
The London-listed, Texas-based predictive-analytics company said Monday that receipt of ISO 13485 confirms its status as a global provider of medical devices which meet the highest quality, reliability, and safety standards.
The company said DeepView is designed to give “immediate, accurate, and binary wound treatment assessments for burn and diabetic foot ulcer indications.”
“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,” the company said.
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