DALLAS, Feb. 07, 2025 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQMDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from the U.S. Food and Drug Administration (“FDA”) in 2018 and uses multi-spectral imaging and AI algorithms to predict burn healing potential, today announced the completion of its data analytics for its U.S. Burn Pivotal Study.   One of the largest domestic burn studies ever conducted, the U.S. Burn Pivotal Study is designed to validate the AI-driven algorithm used by the Company’s DeepView® System for its burn indication. Spectral AI's DeepView® System is a predictive medical device and associated software that assesses the healing potential of burn wounds by combining multispectral imaging with an AI-driven algorithm trained and tested against a proprietary database of more than 340 billion clinically-validated data points. By distinguishing between healing and non-healing tissue, the DeepView® System provides an immediate and binary prediction of wound healing on the same day of injury, benefiting clinical decision-making regarding next step treatment.

DALLAS, Jan. 28, 2025 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQMDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from the U.S. FDA in 2018, that uses multi-spectral imaging and algorithms to predict burn healing potential, today announced the completion of its pediatric enrollment at U.S. emergency departments for its U.S. Burn Pivotal Study. One of the largest domestic burn studies ever conducted, the U.S. Burn Pivotal Study is designed to validate the AI-driven algorithm used by the Company’s DeepView™ System for burn indication.

DALLAS, Jan. 22, 2025 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQMDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from the U.S. FDA in 2018, that uses multi-spectral imaging and algorithms to predict burn healing potential, today announced an update on its operating results.

DALLAS, Dec. 31, 2024 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQMDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from the U.S. FDA in 2018, that uses multi-spectral imaging and algorithms to predict burn healing potential, today announced instructions for retail investors on how to exercise any publicly-traded warrants NASDAQ: MDAIWNASDAQMDAIW)

DALLAS, Dec. 23, 2024 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQMDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from the U.S. FDA in 2018, that uses multi-spectral imaging and algorithms to predict burn healing potential, is pleased to announce that on December 20, 2024 the Company received a “moot” letter from Nasdaq confirming that the Company has regained compliance with all applicable listing standards for its continued listing on the Nasdaq Capital Market and that a further hearing regarding the Company’s compliance is no longer necessary.

DALLAS, Dec. 13, 2024 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQMDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from the U.S. FDA in 2018, that uses multi-spectral imaging and algorithms to predict burn healing potential, today announced today that the Company believes it has regained compliance with Nasdaq Listing Rule 5550(b)(2), which requires listed companies to maintain a minimum market value of listed securities of $35 million.

DALLAS, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQMDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from the U.S. FDA in 2018, that uses multi-spectral imaging and algorithms to predict burn healing potential, today announced that national leaders in burn care have dedicated more than an estimated 511 in-person days of physician engagement to the training and validation studies for the DeepView™ System for U.S. Food and Drug Administration (FDA) submission. This does not include more than an estimated 250 additional days that these experts devoted in Proof-of-Concept studies.

DALLAS, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQMDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on revolutionizing medical diagnostics to enable faster, more accurate treatment decisions in wound care, today announced the completion of enhancements to its technical file to support significant software updates for its DeepView SnapShot® M and DeepView AI-Burn® system in the UK. These upgrades, informed by real-world experience and frontline feedback from clinicians, are designed to enhance product performance and usability in the UK, further solidifying the Company's commitment to delivering and commercializing cutting-edge solutions in critical care settings.

EQNX::TICKER_START (OTCQB:AVAI),(OTCQX:RHHBY),(NASDAQAMZN),NASDAQ:MDAINASDAQMDAI)(NYSE:MDTNYSEMDT EQNX::TICKER_END

DALLAS, Dec. 02, 2024 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQMDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on revolutionizing medical diagnostics to enable faster, more accurate treatment decisions in wound care, today announced the successful completion of truthing for all images gathered from burn centers across the United States. This milestone represents a pivotal step in training the Company's proprietary DeepView® System to predict wound healing outcomes accurately. Having completed the process for burn centers, Spectral AI is now initiating truthing for images collected from emergency departments and emergency rooms nationwide, expanding the scope of the DeepView® System's capabilities.

DALLAS, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQMDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on revolutionizing medical diagnostics to enable faster, more accurate treatment decisions in wound care, today announced the repricing of its 8,433,333 publicly-traded common share purchase warrants with an exercise price of $11.50 per share to $2.75 per share, effective following its twenty day notice requirement. The warrants currently trade on NASDAQ under the symbol MDAIW.

Spectral AI is dedicated to supporting the U.S. Military, first responders, and healthcare providers in delivering life-saving diagnostics in the most critical environments.

DALLAS, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on revolutionizing medical diagnostics to enable faster, more accurate treatment decisions in wound care, today announced the successful completion of an approximate $5.0 million equity financing in an at-the-market transaction. The closing is to be completed in two tranches. Part of the proceeds will be used for the retirement of its outstanding obligations with Yorkville Advisors. This transaction supports Spectral AI’s growth trajectory and progress toward a submission to the U.S. Food and Drug Administration (“FDA”) for approval of its DeepView AI®-Burn system, a crucial milestone targeted for the first half of 2025.

Revenue Rose to $8.2 MillionCompany Reaffirms Timeline for Regulatory Submission to U.S. FDA

Strategic Spinoff Aims to Unlock IP Value and Sharpen Focus on AI Medical Diagnostics

Milestone Achievement Supports Planned FDA Submission of DeepView AI®-Burn in 2025

DALLAS, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced that it will report financial results for the third quarter ended September 30, 2024 on Wednesday, November 6, 2024 after the close of the stock market. The Company will host a corresponding conference call at 5:00 pm Eastern Time that day to discuss the results.  

DALLAS, Oct. 14, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced that the Company's Founder, Dr. J. Michael DiMaio, has been named Chairman of the Board of Directors.

Provides Clinicians with Superior Wound Size Measurement Information that Improves Patient Treatment Decisions

DALLAS, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced that it has achieved 25% patient enrollment at Emergency Departments (“ED”) for its U.S. Burn Pivotal Study and added two new ED Clinical Trial Sites for this study: MedStar Washington Hospital Center in Washington, DC led by Principal Investigator Shawn Tejiram, MD and the University of Utah led by Principal Investigator Giavonni Lewis, MD, FACS. The addition of these two clinical research sites expands participating EDs to 11 facilities.

DALLAS, Sept. 17, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today provided an outline of its regulatory pathway strategy to enter the U.S. market with its flagship DeepView® System for burn indication (“DeepView AI®-Burn”). 

Spectral AI’s DeepView® System Designed to Provide Equity in Burn Care Access While Optimizing Healthcare Resources

Project Funding Exceeds $7.0 Million

DALLAS, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced that Peter M. Carlson, Chief Executive Officer, and Vince Capone, Chief Financial Officer, are scheduled to participate in the following investor conferences in New York City: