Michael Barbella, Managing Editor10.19.23
Spectral AI Holdings Ltd. has received ISO 13485 certification for the manufacture and distribution of its AI-driven DeepView Wound Imaging System, designed to provide immediate, accurate, and binary wound treatment assessments for burns and diabetic foot ulcers.
ISO 13485 is an internationally recognized standard that ensures the quality of medical device design, development, and production. To receive certification, organizations must demonstrate their Quality Management Systems (QMS) deliver medical devices and related services that consistently meet stringent customer and regulatory requirements. Spectral AI’s ISO 13485 certification was awarded after a comprehensive audit of its QMS undertaken by an independent registrar earlier this year.
“The receipt of ISO 13485 confirms Spectral AI’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 AI’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 AI Chief Operating Officer of Spectral AI Niko Pagoulatos said.
Spectral AI’s DeepView Wound Imaging System, which received U.S. Food and Drug Administration Breakthrough Device Designation in 2018 for its burn indication, integrates optical technology and artificial intelligence (AI)-enabled algorithms using a proprietary database of more than 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.
Spectral AI is a predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care for burn, diabetic foot ulcers, and future clinical applications. The company is striving to revolutionize wound care management by “Seeing the Unknown” with its DeepView Wound Diagnostics System. With algorithm-driven results that have a goal of substantially exceeding the current standard of care in the future, Spectral AI’s diagnostic platform is expected to provide faster and more accurate treatment insight and improve patient care while reducing healthcare costs.
As announced on April 11, 2023, Spectral AI Holdings has agreed to combine with Rosecliff Acquisition Corp I, a special purpose acquisition company listed on Nasdaq.
ISO 13485 is an internationally recognized standard that ensures the quality of medical device design, development, and production. To receive certification, organizations must demonstrate their Quality Management Systems (QMS) deliver medical devices and related services that consistently meet stringent customer and regulatory requirements. Spectral AI’s ISO 13485 certification was awarded after a comprehensive audit of its QMS undertaken by an independent registrar earlier this year.
“The receipt of ISO 13485 confirms Spectral AI’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 AI’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 AI Chief Operating Officer of Spectral AI Niko Pagoulatos said.
Spectral AI’s DeepView Wound Imaging System, which received U.S. Food and Drug Administration Breakthrough Device Designation in 2018 for its burn indication, integrates optical technology and artificial intelligence (AI)-enabled algorithms using a proprietary database of more than 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.
Spectral AI is a predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care for burn, diabetic foot ulcers, and future clinical applications. The company is striving to revolutionize wound care management by “Seeing the Unknown” with its DeepView Wound Diagnostics System. With algorithm-driven results that have a goal of substantially exceeding the current standard of care in the future, Spectral AI’s diagnostic platform is expected to provide faster and more accurate treatment insight and improve patient care while reducing healthcare costs.
As announced on April 11, 2023, Spectral AI Holdings has agreed to combine with Rosecliff Acquisition Corp I, a special purpose acquisition company listed on Nasdaq.