Spectral AI Expects To Pursue De Novo Submission Requesting Classification Of DeepView AI-Burn As A Class II Medical Device, Expects To Submit In Q2 Of 2025
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Spectral AI plans to submit a De Novo request for its DeepView AI-Burn device to be classified as a Class II medical device by Q2 2025.
September 17, 2024 | 12:05 pm
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Spectral AI is preparing to submit a De Novo request for its DeepView AI-Burn device to be classified as a Class II medical device by Q2 2025. This regulatory step is crucial for market entry and could impact the company's future revenues.
The De Novo submission is a significant regulatory step for Spectral AI's DeepView AI-Burn device. If successful, it could lead to market entry and potential revenue growth, positively impacting MDAI's stock price.
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