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Spectral AI Submits De Novo Request for DeepView System

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Spectral AI Submits De Novo Request for DeepView System

Elevate Your Investing Strategy:

The latest update is out from Spectral AI ( (MDAI) ).

On June 30, 2025, Spectral AI announced the submission of its De Novo request to the U.S. FDA for its DeepView System, a non-invasive predictive medical device for burn care settings. This milestone is significant for the company as it seeks to introduce this innovative diagnostic tool to the U.S. market, potentially enhancing clinical decision-making and patient outcomes. Supported by federal funds, the DeepView System uses multispectral imaging and AI to predict burn healing potential, offering clinicians immediate insights for better treatment decisions.

The most recent analyst rating on (MDAI) stock is a Buy with a $3.00 price target. To see the full list of analyst forecasts on Spectral AI stock, see the MDAI Stock Forecast page.

Spark’s Take on MDAI Stock

According to Spark, TipRanks’ AI Analyst, MDAI is a Neutral.

Spectral AI shows significant revenue growth and strategic technological developments, yet faces substantial financial challenges with negative profitability and high leverage. Technical indicators suggest bearish momentum, and the valuation appears unattractive due to the negative P/E ratio. The earnings call presents a mixed outlook, highlighting achievements but also projecting revenue declines, contributing to a cautious overall assessment.

To see Spark’s full report on MDAI stock, click here.

More about Spectral AI

Spectral AI, Inc. is a Dallas-based predictive AI company specializing in medical diagnostics to enhance treatment decisions in wound care, with a primary focus on burn patients. The company aims to transform wound care management with its DeepView System, a predictive device designed to provide clinicians with immediate assessments of burn wounds’ healing potential, thereby improving patient outcomes and reducing healthcare costs.

Average Trading Volume: 312,873

Technical Sentiment Signal: Buy

Current Market Cap: $54.58M

For detailed information about MDAI stock, go to TipRanks’ Stock Analysis page.

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