MDAI

Provides Update and Outlook Following Receipt of FDA De Novo Clearance for DeepView® System for Burn Indication DALLAS, June 01, 2026 (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 results from its 2026 Annual Meeting of Stockholders, held on May 29, 2026. The Company also provided an overview of its accomplishments to date and targeted milestones for 2026 following the receipt of De Novo Classification for its DeepView® System from the U.S. Food and Drug Administration (“FDA”). 2026 Annual Meeting of Stockholders A total of 17,267,570 shares representing 54.3% of the Company’s total shares outstanding were represented at the meeting, either in person or by proxy. All three of the proposals set forth by the Company were approved by its stockholders. The voting results are detailed below. Five directors were elected to serve on the Company’s Board of Directors until the next Annual Meeting of Stockholders: Dr. J. Michael DiMaio, MD, a founder of the Company and Chairman of the Board of Directors Richard Cotton, Chairman of the Company’s Audit Committee and Lead Independent Director Marion Snyder, Zone Vice President, Strategic Accounts, at Shockwave Medical The Company’s stockholders also ratified the appointment of Forvis Mazars, LLP as the Company’s independent registered public accounting firm for the 2026 fiscal year and authorized the reservation and issuance of shares of common stock pursuant to a Securities Purchase Agreement dated October 24, 2025. A New Chapter for Spectral AI “The receipt of FDA clearance for our DeepView System for Burn Indication is the culmination of years of hard work by our dedicated team and a defining moment in Spectral AI’s history,” said Vincent Capone, Chief Executive Officer. “Spectral AI is now poised to evolve from a late stage, pre-clearance medical device company to a scaling, commercially focused enterprise. We are moving forward with renewed momentum and a clear vision for the future.” Key 2026 Operational and Business Achievements Received FDA clearance for the DeepView System for Burn Indication; with this classification, Spectral AI is now authorized to commence commercial distribution activities in the United States. Awarded...

By John Vandermosten, CFA NASDAQ: MDAI READ THE FULL MDAI RESEARCH REPORT Spectral AI, Inc. (NASDAQ: MDAI) reported first quarter 2026 results on May 12th after the market close. Since the previous financial update about a month and a half ago, the company has appointed David McGuire as Chief Financial Officer (CFO), presented DeepView at the American Burn Association, and received the Small Business Innovator Award in Texas. CEO Vincent Capone also participated in a podcast discussing DeepView’s opportunities, where he identified some of the company’s long-term objectives. During its earnings presentation, the company reaffirmed 2026 research and development revenue guidance of $18.5 million. The guidance excludes product revenues. Spectral believes there will be deployments inside and outside the United States in 2026. It plans to update its United Kingdom Conformity Assessed (UKCA) burn assessment mark approval to reflect improvements, which could lead to UK sales after the updated labeling. Back stateside, Spectral confirmed that a prototype handheld version of DeepView was delivered to MTEC for review. It expects that if the agency accepts the device, MTEC may award another grant in December 2026. The search for a Chief Commercial Officer continues, and we think that an appointment could be announced in the next month. 1Q:26 Financial and Operational Results Spectral reported 1Q:26 results in a press release on May 12th, followed by a conference call to discuss results with investors and take questions from analysts. A Form 10-Q was subsequently filed with the SEC. For the quarter ending March 31st, 2026, Spectral recognized research and development revenues of $4.0 million. Net loss from operations was $2.0 million. For 1Q:26 versus the same, prior year period: Revenues of $4.0 million fell 40% from $6.7 million, reflecting a reduction in direct labor, clinical trial, and other reimbursed study costs related to the BARDA contract. This was partially offset by work on other contracts, including the Medical Technology Enterprise Consortium (MTEC) for the handheld device; Cost of revenue, which can be thought of as research and development expense, totaled $2.0 million, down 45% from $3.5 million due to decreased development activity. Gross margin rose 356 basis points to 50.8%, reflecting a higher concentration of direct labor as a percentage of the tota...

Development Work for DeepView® Systems Continues with Support of Recently Awarded $31.7 Million of Funding from BARDA Reiterates Annual Revenues Guidance DALLAS, May 12, 2026 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the first quarter ended March 31, 2026. “Our results for the 2026 first quarter reflected the progress we have made in developing our DeepView® System for burn indication under the base phase of our Project BioShield Contract with BARDA,” said Vincent Capone, Chief Executive Officer of Spectral AI. “The work we have completed under this base phase – which was ongoing in last year’s first quarter - allowed us to submit our De Novo 510(k) application to the U.S. Food and Drug Administration (“FDA”) for the DeepView System in June 2025. As we await determination on market authorization from the FDA, we are furthering the development of the DeepView System under an accelerated second phase of our contract with BARDA that includes $31.7 million of advanced, non-dilutive funding.” Mr. Capone concluded, “Our financial condition remains strong, and we continue to make investments that align with our strategic priorities and in advance of planned commercialization activities. One such priority was to strengthen our leadership team, and I am happy to once again welcome David McGuire as the Company’s Chief Financial Officer. David brings a wealth of relevant public company experience to his role at Spectral AI and his appointment helps bolster our leadership team for the next exciting phase of our growth.” 2026 FIRST QUARTER (“Q1 2026”) FINANCIAL RESULTS OVERVIEW All comparisons to Q1 2026 are to the comparable period ended March 31, 2025 unless otherwise stated. Research & Development Revenue Research & Development revenue for Q1 2026 was $4.0 million compared to $6.7 million, reflecting the anticipated decline in completed work under the base phase of the Company’s Project BioShield (PBS) contract with the Biomedical Advanced Research and Development Authority (BARDA). This was partially offset by an increase in revenue from awards and work performed under the Company’s other U.S. government contracts, primarily related to work on the Company’s...

Interested in Spectral AI, Inc.? Here are five stocks we like better. Spectral AI said it remains on track for FDA clearance of its DeepView burn assessment system, with a response expected by the end of Q2 2026 and a goal of commercializing in late 2026 if approved. The company received $31.7 million in BARDA funding, which will support product development and deployment, but management said most of the revenue recognition is expected in 2027 rather than 2026. First-quarter R&D revenue fell to $4.0 million from $6.7 million a year earlier as base BARDA contract work ended, though that was partly offset by other government contract activity and an improved gross margin of 50.8%. Spectral AI (NASDAQ:MDAI) said it remains on track toward potential U.S. regulatory clearance and commercialization of its DeepView system for burn assessment, while reporting lower first-quarter research and development revenue tied to the completion of work under a federal contract. On the company’s first-quarter 2026 earnings call, Chief Executive Officer Vincent Capone said the period was defined by “progress and preparation,” citing ongoing discussions with the U.S. Food and Drug Administration, expanded government funding and steps toward building a commercial infrastructure. → MercadoLibre Boldly Invests in Growth: Discount Deepens Spectral AI submitted its De Novo application to the FDA in June 2025 for the DeepView system. Capone said the company has responded to additional information requests and “maintained an active dialogue” with the agency. The company continues to expect a response before the end of the second quarter of 2026. “I think that we're in as good a position as we can be, and I think our timeline has remained solid,” Capone said during the question-and-answer portion of the call. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? Capone said Spectral AI hopes to move quickly to commercialize DeepView by the end of 2026 if it receives FDA clearance. The company is also working with Deloitte Consulting to finalize its commercialization strategy and is continuing a search for a chief commercial officer. The company is preparing an outcome study intended to evaluate the benefits of DeepView across clinician workflows and the patient care journey. Capone said the study is expected to include approximately 240 patients across 12 clinical site...

This article first appeared on GuruFocus. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Spectral AI Inc (NASDAQ:MDAI) has submitted a de novo application to the FDA and anticipates a response by the end of Q2 2026, which could lead to the commercialization of their DeepU system by the end of the year. The company secured $31.7 million in advanced funding from BARDA, which will support the development and procurement of up to 30 devices for burn centers and trauma centers. Spectral AI Inc (NASDAQ:MDAI) has expanded its leadership team, including the addition of a new CFO, and is working with Deloitte Consulting to finalize its commercialization strategy. The company successfully delivered a prototype of its handheld device to MTEC, which is part of a Department of Defense contract, and anticipates pursuing further phases of the contract. Spectral AI Inc (NASDAQ:MDAI) received the Small Business Innovator Award at the Texas Innovation Conference, highlighting its commitment to developing technology that improves patient outcomes for burn victims. R&D revenue for Q1 2026 decreased to $4 million from $6.7 million year-over-year, primarily due to the completion of work under the base phase of the company's Project BioShield contract with BARDA. The company reported a net loss of $3.4 million for Q1 2026, compared to a net income of $2.9 million in the prior-year period. Cash reserves decreased from $15.4 million at the end of 2025 to $11.7 million as of March 31, 2026, reflecting continued investment in R&D and commercialization initiatives. Spectral AI Inc (NASDAQ:MDAI) does not expect significant contributions from the sale of the DeepU system in its 2026 revenue guidance of $18.5 million. The company faces uncertainties related to FDA approval timelines and the potential impact on its commercialization plans. Warning! GuruFocus has detected 4 Warning Signs with MDAI. Is MDAI fairly valued? Test your thesis with our free DCF calculator. Q: Vince, can you expand on the FDA clearance timeline and the commercial activities in preparation for the DeepView launch? A: (Vincent Capone, CEO) We've had several pre-submission meetings with the FDA, and our submission was strong. We've maintained an active dialogue with the FDA and expect a resolution by the end of Q2. Commercially, we've be...

This article first appeared on GuruFocus. Spectral AI Inc (NASDAQ:MDAI) is set to release its Q1 2026 earnings on May 12, 2026. The consensus estimate for Q1 2026 revenue is $4.13 million, and the earnings are expected to come in at -$0.07 per share. The full year 2026's revenue is expected to be $18.86 million and the earnings are expected to be -$0.50 per share. More detailed estimate data can be found on the Forecast page. Warning! GuruFocus has detected 4 Warning Signs with MDAI. Is MDAI fairly valued? Test your thesis with our free DCF calculator. Revenue estimates for Spectral AI Inc (NASDAQ:MDAI) have increased from $14.06 million to $18.86 million for the full year 2026 and increased from $23.03 million to $23.29 million for 2027 over the past 90 days. Earnings estimates have improved from -$0.68 per share to -$0.50 per share for the full year 2026 and from -$0.71 per share to -$0.62 per share for 2027 over the past 90 days. In the previous quarter of December 31, 2025, Spectral AI Inc's (NASDAQ:MDAI) actual revenue was $3.85 million, which beat analysts' revenue expectations of $2.92 million by 31.68%. Spectral AI Inc's (NASDAQ:MDAI) actual earnings were $0.02 per share, which beat analysts' earnings expectations of -$0.12 per share by 116.67%. After releasing the results, Spectral AI Inc (NASDAQ:MDAI) was down by 4.07% in one day. Based on the one-year price targets offered by 3 analysts, the average target price for Spectral AI Inc (NASDAQ:MDAI) is $4.67, with a high estimate of $6.00 and a low estimate of $3.00. The average target implies an upside of 102.02% from the current price of $2.31. Based on GuruFocus estimates, the estimated GF Value for Spectral AI Inc (NASDAQ:MDAI) in one year is $0, suggesting a downside of 100% from the current price of $2.31. Based on the consensus recommendation from 2 brokerage firms, Spectral AI Inc's (NASDAQ:MDAI) average brokerage recommendation is currently 1.5, indicating a "Buy" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

DALLAS, April 28, 2026 (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 first quarter ended March 31, 2026 on Tuesday, May 12, 2026 after the close of the Nasdaq stock market. The Company will host a corresponding conference call at 5:00 pm Eastern Time on the same day to discuss its financial results. Investors interested in participating in the live call can dial into the conference call as follows: 833-890-6620 – U.S. 412-564-3789 – International In addition, a simultaneous webcast of the financial results call may be accessed online from the Events section of the Investor Relations page of the Company’s website at https://investors.spectral-ai.com/news-events/events. About Spectral AI Spectral AI, Inc. 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. The Company is working to revolutionize the management of wound care by “Seeing the Unknown®” with its DeepView System. The DeepView System is being developed as a predictive diagnostic device to offer clinicians an objective and immediate assessment of a burn wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal of exceeding the current standard of care in the future, the DeepView System is expected to provide fast and accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs. Spectral AI has been named to TIME’s list of World’s Top HealthTech companies 2025. For more information about the DeepView System, visit www.spectral-ai.com. Forward-Looking Statements Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s strategy, plans, objectives, initiatives and financial outlook. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,”...

Performance in 2025 was defined by the transition from clinical validation to regulatory submission, culminating in the June de novo application for the DeepView burn indication. The DeepView system is strategically positioned as a critical triage tool for mass casualty events, addressing an unmet need for rapid surgical burden management and resource allocation. Validation study results from 164 patients across 15 centers demonstrated that the AI-driven system significantly outperformed the clinical judgment of burn physicians. Management attributes the company's strengthened financial position to successful debt and equity financings, tripling the cash balance to $15.4 million by year-end. The partnership with BARDA remains a primary driver of development, with a recent $31.7 million award intended to accelerate feature enhancements like EHR integration. Operational focus has shifted toward commercial infrastructure, including the engagement of external consultants to refine the go-to-market strategy for 2026. Revenue guidance for 2026 is approximately $18.5 million, primarily driven by BARDA funding and excluding significant contributions from initial DeepView system sales. Management anticipates a potential positive FDA response before the end of Q2 2026, which would trigger the initiation of real-world hospital outcome studies. Commercial activities are expected to begin in earnest in late 2026, supported by existing manufacturing relationships and an expanded sales team. International expansion is slated for late 2026, focusing on the U.K., Australia, and GCC nations following an updated UKCA authorization to match the FDA-cleared version. The company plans to deliver a fully functioning prototype of its handheld diagnostic device by the end of Q2 2026 under its Department of Defense contract. The company received an 'additional information' notification from the FDA regarding its de novo application, though management states the feedback was consistent with expectations. A $4 million gain in the fair value of warrant liability significantly impacted Q4 net income, highlighting the volatility of non-cash financial instruments. The BARDA contract includes a provision for subsidized distribution of up to 170 systems, which may impact the timing and structure of early revenue recognition. Future R&D commitments include a $9.7 million company contribution...

Image source: The Motley Fool. Tuesday, March 24, 2026 at 5 p.m. ET Chief Executive Officer — Vincent Capone Corporate Controller — Thomas Spieth Need a quote from a Motley Fool analyst? Email [email protected] Vincent Capone, the company's Chief Executive Officer; and Thomas Speith, our Corporate Controller. Before we begin, I'd like to remind everyone that during this call, certain statements made are forward-looking statements within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the company's strategy, plans, objectives, initiatives and financial outlook. When used in this call, the words estimates, projected, expects, anticipates, forecasts, plans, intends, believes, seeks, may, will, should, future, propose and variations of these words or similar expressions or the negative versions of such words or expressions are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the company's control that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, listeners are cautioned not to place undue reliance on any forward-looking statements. Investors should carefully consider the foregoing factors and the other risks and uncertainties described in the Risk Factors section of the company's filings with the SEC, including the registration statement and other documents filed by the company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. With that, I'd now like to turn the call over to Vincent Capone, Spectral AI's Chief Executive Officer. Vince, please go ahead. Vincent Capone: Thanks, Devin, and thank you all for joining us today. We issued our earnings release this afternoon, which contains additional details of our operating results. We will also file our 10-K with the SEC later this evening. Today, I will focus my remarks on our year-end review and corporate developments, and our Controller, Tom Spieth, will take us through our key fin...

This article first appeared on GuruFocus. Q4 2025 Research and Development Revenue: $3.8 million, down from $7.6 million in Q4 2024. Q4 2025 Gross Margin: 39.8%, compared to 44.0% in Q4 2024. Q4 2025 General and Administrative Expenses: $4.0 million, down from $4.5 million in Q4 2024. Q4 2025 Net Income: $0.6 million or $0.02 per diluted share, compared to a net loss of $7.7 million or negative $0.41 per diluted share in Q4 2024. Full Year 2025 Research and Development Revenue: $19.7 million, down from $29.6 million in 2024. Full Year 2025 Gross Margin: 45.4%, compared to 44.9% in 2024. Full Year 2025 General and Administrative Expenses: $17.5 million, down from $19.9 million in 2024. Full Year 2025 Net Loss: $7.6 million or negative $0.29 per diluted share, compared to a net loss of $15.3 million or negative $0.85 per diluted share in 2024. Cash Position as of December 31, 2025: $15.4 million, up from $5.2 million as of December 31, 2024. Total Debt as of December 31, 2025: $8.5 million. 2026 Revenue Forecast: Approximately $18.5 million. Warning! GuruFocus has detected 4 Warning Signs with MDAI. Is MDAI fairly valued? Test your thesis with our free DCF calculator. Release Date: March 24, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Spectral AI Inc (NASDAQ:MDAI) made significant progress in 2025 towards commercializing its Deep View system for burn indications. The company completed a large-scale burn validation study, which demonstrated the Deep View system's superior performance compared to clinical judgment. Spectral AI Inc (NASDAQ:MDAI) received $31.7 million in advanced funding from the Biomedical Advanced Research and Development Authority (BARDA) to accelerate the development of its diagnostic device. The company has a strong cash position, with cash reserves tripling to over $15 million by the end of 2025. Spectral AI Inc (NASDAQ:MDAI) is preparing for commercialization by expanding its sales team and engaging Deloitte Consulting for strategic planning. Research and development revenue decreased significantly from $29.6 million in 2024 to $19.7 million in 2025. The company experienced a reduction in gross margin for Q4 2025, dropping from 44.0% to 39.8%. Spectral AI Inc (NASDAQ:MDAI) reported a net loss of $7.6 million for the year, despite improvements from the previous year. The anticipa...

Overview Full Year Research & Development Revenue of $19.7 Million; Q4 2025 Revenue of $3.8 Million Cash Rose to $15.4 Million at December 31, 2025 DALLAS, March 24, 2026 (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 financial results for the fourth quarter (“Q4 2025”) and full year (“FY 2025”) ended December 31, 2025 and provided an update on its ongoing activities related to the commercialization of its proprietary, AI-driven DeepView® System for burn indication. “2025 was a pivotal year for Spectral AI, highlighted by the submission of our De Novo 510(k) application to the U.S. Food and Drug Administration (“FDA”) of our DeepView System for burn indication,” said Vincent Capone, Chief Executive Officer of Spectral AI. “We continue to make significant progress along numerous fronts in preparation for the anticipated commercialization of this innovative diagnostic device. The reception of our technology at burn conferences in the U.S., UK, and Europe has been exceptional.” Mr. Capone concluded, “We ended the year in a strong financial position, especially with our cash balance above $15.0 million at year-end, and we continue to manage expenses to ensure that spending aligns with our strategic priorities and commercialization. We are confident that we have the people, processes, and platform in place to prepare for the next exciting phase of our growth.” Additional BARDA Funding As previously announced, the Company received $31.7 million in funding from the Biomedical Advanced Research and Development Authority (“BARDA”) to accelerate and support the development of additional feature aspects for the DeepView System. The Company has committed to provide an additional $9.7 million to the total overall development costs associated with these feature advancements. This immediate, non-dilutive funding was advanced in addition to the $54.9 million of funding committed to date as part of the Company’s current contract with BARDA that is valued at up to $150.0 million. 2025 FINANCIAL RESULTS OVERVIEW All comparisons to Q4 2025 and FY 2025 are to the comparable periods ended December 31, 2024 unless otherwise stated. Research & Development Revenue Research & Development revenu...