Spectral AI Announces Submission to FDA of its DeepView® System

Written by Emily J. Thompson, Senior Investment Analyst

MDAI-6.08%

MDAIW0%

Source: Newsfilter

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Source: Newsfilter

FDA Submission: Spectral AI has submitted a De Novo 510k marketing clearance application to the FDA for its DeepView® System, an AI-driven device designed to predict burn healing potential in clinical settings, marking a significant milestone for the company.
Technology Overview: The DeepView System utilizes multi-spectral imaging and AI algorithms to provide non-invasive, immediate assessments of burn wounds, aiming to enhance treatment decisions and improve patient outcomes in wound care management.

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MDAI

$1.775+Infinity%1D

Analyst Views on MDAI

Wall Street analysts forecast MDAI stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for MDAI is 4.50 USD with a low forecast of 3.00 USD and a high forecast of 6.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.

2 Analyst Rating

2 Buy

0 Hold

0 Sell

Moderate Buy

Current: 1.890

Low

3.00

Averages

4.50

High

6.00

Current: 1.890

Low

3.00

Averages

4.50

High

6.00

BTIG

Buy

downgrade

$3 -> $2

2025-05-14

Reason

BTIG

Price Target

$3 -> $2

AI Analysis

2025-05-14

downgrade

Buy

Reason

BTIG lowered the firm's price target on Spectral AI to $2 from $3 and keeps a Buy rating on the shares after its Q1 results. The company is appropriately trimming operating spend to preserve cash, though the firm is reducing its price target to reflect a higher share count, the analyst tells investors in a research note. Spectral AI also continues to expect to submit DeepView to the FDA by the end of 2Q25 with approval expected in early FY26, the firm adds.

HC Wainwright & Co.

Swayampakula Ramakanth

Strong Buy

Reiterates

$3.5

2025-04-02

Reason

HC Wainwright & Co.

Swayampakula Ramakanth

Price Target

$3.5

2025-04-02

Reiterates

Strong Buy

Reason

About MDAI

Spectral AI, Inc. is a predictive artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns. The Company's DeepView platform is a predictive device that offers clinicians an objective and immediate assessment of a wound healing potential prior to treatment or other medical intervention. DeepView platform that combines AI algorithms and multispectral imaging (MSI) imaging for an assessment of wound healing potential. It is non-invasive, non-radiation, non-laser and does not require the use of injectable dye. The DeepView AI- Burn software is used with the DeepView SnapShot imaging device, and it is intended to be used as an adjunctive tool to aid healthcare providers in the assessment of burn wound healing potential by differentiating non-healing from healing burned tissue within an image.

About the author

Emily J. Thompson

Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.