Spectral AI has received the UK Conformity Assessed (UKCA) mark and Class 1 medical device classification from the US Food and Drug Administration (FDA) for its DeepView SnapShotWound Imaging System.
DeepView SnapShot is a patented imaging platform that accommodates various clinical indications and predictive AI software, aiding clinicians in making quicker and more precise wound care decisions.
It integrates optical technology and AI-driven algorithms, drawing from a database of 263 billion data points that are clinically validated, to view beneath the surface of the skin and differentiate between healthy and damaged tissue.
The company now plans to obtain regulatory approval for its DeepView AI – Burn software to launch the complete DeepView SnapShot system in the US and worldwide.
DeepView is a predictive diagnostic tool that provides clinicians with an instant, objective assessment of a wound’s healing potential before any treatment or medical intervention.
It is anticipated to deliver faster and more accurate treatment insights aimed at surpassing the current standard of care, driven by advanced algorithms.
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Spectral AI CEO Wensheng Fan said: “We are thrilled to announce the UKCA marking and Class 1 medical device classification from the FDA for our DeepView SnapShotWound Imaging System.
“Spectral AI’s commitment to advancing medical diagnostics in tissue health is reflected in these important milestones.
“We are confident that our unique AI-driven imaging platform will empower healthcare professionals in making critical decisions around the world, and these regulatory developments are significant steps towards achieving that goal.”