Spectral MD Holdings Ltd announced on Monday that it has successfully obtained ISO 13485 certification, validating its capacity to manufacture and distribute the AI-driven DeepView wound imaging system.
The London-based artificial intelligence company specialises in medical diagnostics, particularly in the realm of wound care treatment.
The DeepView wound imaging system, as elucidated by the company, is meticulously crafted to furnish instantaneous, precise, and binary evaluations of wound treatments, specifically catering to burn and diabetic foot ulcer cases.
Spectral emphasised that ISO 13485 is a universally acknowledged benchmark that underscores the excellence in the design, development, and production of medical devices. The certification is bestowed upon organisations that exhibit the consistent delivery of medical devices and correlated services, adhering to rigorous customer and regulatory prerequisites.
Niko Pagoulatos, the Chief Operating Officer, affirmed, "The attainment of ISO 13485 certification serves as a testament to Spectral MD's global prominence as a provider of medical devices that adhere to the highest standards of quality, dependability, and safety."
On Monday morning, shares of Spectral experienced a 1.7% surge, reaching 52.35 pence apiece on the London stock exchange.
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