Spectral AI Inc (NASDAQ:MDAI) shares surged in pre-market trade after the company announced that its DeepView SnapShot Wound Imaging System is now United Kingdom Conformity Assessed (UKCA)-marked for use in the UK and it has achieved Class 1 medical device classification from the United States Food and Drug Administration (FDA).
The company’s DeepView SnapShot is a patented, universal imaging platform that uses predictive artificial intelligence (AI) software to assist clinicians in making quicker and more accurate decisions in wound care.
Optical technology and AI-enabled algorithms use a proprietary database of 263 billion clinically validated data points to see beneath the skin’s surface and differentiate healthy and damaged tissue.
Having achieved UKCA marking, Spectral AI said it has shipped six DeepView Snapshot Devices to UK burn centres for evaluation.
In the United States, having received Class 1 medical device classification from the FDA, the company said it will now seek regulatory approval for its DeepView AI – Burn software to commercialize the complete DeepView SnapShot System.
“Spectral AI's commitment to advancing medical diagnostics in tissue health is reflected in these important milestones,” Spectral AI CEO Wensheng Fan said in a statement.
“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.”
Spectral AI chief operating officer Niko Pagoulatos added: “We are very pleased with these important incremental regulatory developments in the UK and the US as part of our ongoing efforts to commercialize the DeepView platform.”
Investors were impressed by the news, with Spectral AI’s shares up 63.1% at US$4.22 shortly before noon on Thursday.
Spectral AI is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns and diabetic foot ulcers.
- Updated with share price movement -
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