Welcome to our dedicated page for Spectral AI news (Ticker: MDAI), a resource for investors and traders seeking the latest updates and insights on Spectral AI stock.
Spectral AI, Inc. (Nasdaq: MDAI) is an artificial intelligence company dedicated to advancing medical diagnostics, particularly in wound care. The company's flagship product, the DeepView™ System, is a cutting-edge multispectral imaging (MSI) device designed to assist physicians in making accurate and timely treatment decisions. This innovative technology leverages proprietary algorithms to differentiate between damaged and healthy tissue, producing critical Day One healing assessments within seconds.
Spectral AI's DeepView System has received FDA Breakthrough Device Designation due to its potential to significantly improve patient outcomes. The primary focus of the company lies in the research and development of this system. Notably, a substantial portion of its funding comes from the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services.
In recent developments, Spectral AI was honored with the Commitment to Quality Achievement Award by the Texas Manufacturer Assistance Center (TMAC) for their attainment of the UKCA Mark. This accolade underscores the company’s dedication to maintaining the highest standards of quality while working towards the commercialization of DeepView technology.
The company frequently updates its stakeholders through conference calls and presentations, which can be accessed via the investor relations section of its website. This proactive communication strategy ensures transparency and keeps investors well-informed about the company's progress and financial health.
Investor Relations Contacts:
Devin Sullivan, Managing Director at The Equity Group, can be reached at dsullivan@equityny.com.
Conor Rodriguez, Analyst at The Equity Group, can be contacted at crodriguez@equityny.com.
Media Contacts:
David Schull of Russo Partners can be reached at david.schull@russopartnersllc.com or (858) 717-2310.
Spectral AI (Nasdaq: MDAI) has received an additional $850,000 award from the Medical Technology Enterprise Consortium (MTEC) to support the development of DeepView SnapShot M®, a handheld predictive burn wound healing device for battlefield assessment. This brings the total non-dilutive government funding for the project to over $7.0 million.
DeepView SnapShot M® is designed to provide quick and accurate wound assessment in combat zones and military hospitals, aligning with MTEC's mission to protect and optimize U.S. military personnel health. The device is based on Spectral AI's DeepView™ System platform, which uses multispectral imaging and an AI-driven algorithm trained on over 340 billion clinically validated data points to assess burn wound healing potential.
Spectral AI (Nasdaq: MDAI), an AI company specializing in medical diagnostics for wound care, has announced its participation in two upcoming investor conferences in New York City. Peter M. Carlson, CEO, and Vince Capone, CFO, will represent the company at these events:
1. H.C. Wainwright 26th Annual Global Investment Conference (September 9-11, 2024): A virtual fireside chat will be available from September 9 at 7:00 am ET, accessible via the company's website. One-on-one meetings will be held throughout the day.
2. Lake Street BIG8 Investor Conference (September 12, 2024): The company will participate in one-on-one meetings throughout the day.
These conferences provide Spectral AI with opportunities to engage with investors and showcase their AI-driven medical diagnostics technology for wound care treatment decisions.
Spectral AI (Nasdaq: MDAI) has completed adult and pediatric patient enrollment at U.S. burn centers for its U.S. Burn Pivotal Study, one of the largest domestic burn studies ever conducted. This milestone advances the commercialization timeline for the company's DeepView™ System for burn indication. The study aims to validate the AI-driven algorithm used by DeepView™, which assesses burn healing potential using multi-spectral imaging and a proprietary database of over 340 billion clinically validated data points.
Spectral AI plans to submit a De Novo classification request to the FDA in Q2 2025 for the use of DeepView™ in burn centers. The system has shown superior accuracy in assessing burn wounds compared to current standards. The company is continuing to enroll patients at Emergency Departments, with a subsequent 510(k) application planned for ED use following FDA approval for burn centers.
Spectral AI (Nasdaq: MDAI) announced a podium presentation at the BBA/ISBI Joint Conference by Dr. Jeffrey Carter, showcasing data from an ongoing study on their DeepView™ System. This AI-driven technology uses multispectral imaging to assess burn wound severity with accuracy exceeding experienced physicians. The presentation highlights the potential of DeepView™ to address challenges in burn care, including resources and the need for accurate diagnoses.
The company's 2024 U.S. Burn Pivotal Study is ongoing, aiming to validate the AI algorithm before seeking FDA approval in 2025. Spectral AI believes their system can significantly impact the speed, treatment, and outcomes for acute burn wound patients, especially in mass casualty events where current healthcare systems face constraints.
Spectral AI (NASDAQ: MDAI) reported Q2 2024 financial results, highlighting $7.5 million in Research & Development Revenue, a 76% increase from Q2 2023. The company's U.S. Burn Pivotal Study has exceeded 85% enrollment, paving the way for FDA submission in early 2025. Spectral AI maintains a cash position of $6.9 million and is on track to generate its first commercial revenues in the U.K. later this year.
Key developments include:
- Progress in handheld burn wound diagnostic technology
- Collaboration with PolyNovo for Australian market entry
- Addition to Russell Microcap® Index
- Deployment of five DeepView Burn devices in the U.K.
The company reiterates its FY 2024 revenue guidance of approximately $28.0 million.
Spectral AI (Nasdaq: MDAI) announced progress in developing DeepView SnapShot® M, a handheld diagnostic tool for battlefield burn assessment. The device, based on the Company's AI-driven DeepView™ System platform, aims to provide quick and accurate wound assessment for prioritizing evacuation in combat settings. Key advancements include:
1. Miniaturization of five cameras without compromising wavelength depth or accuracy
2. Image capture time under one second
3. Optimization for field-based settings with reduced unwanted light
An abstract on the device's development has been accepted for poster presentation at the 2024 Military Health System Research Symposium (August 26-29, 2024).
Spectral AI (Nasdaq: MDAI), an AI company specializing in medical diagnostics for wound care, has announced its schedule for reporting 2024 second quarter financial results. The company will release its financial report on Monday, August 12, 2024, after the stock market closes. Following the release, Spectral AI will host a conference call at 5:00 pm Eastern Time to discuss the results.
Investors interested in participating in the live call can dial 833-630-1956 for U.S. callers or 412-317-1837 for international callers. Additionally, a simultaneous webcast of the call will be accessible from the Events & Presentations section of the company's Investor Relations page at https://investors.spectral-ai.com/news-events/events.
Spectral AI (Nasdaq: MDAI) has announced a 30% increase in its patent portfolio, strengthening its proprietary AI-driven DeepView System for wound assessment. The company now holds 26 granted patents (12 U.S. and 14 international) and 38 pending applications worldwide. These patents cover various aspects of the DeepView System, including tissue classification, machine learning, and high-precision imaging.
CEO Peter M. Carlson emphasized the novel nature of the DeepView System and its ability to provide immediate, objective wound healing assessments. The company plans to commence product commercialization initiatives in late 2024 through 2026. Board member Erich Spangenberg, a recognized IP expert and the company's largest shareholder, is actively supporting management in building a strong intellectual property position.
Spectral AI (Nasdaq: MDAI) has added three new U.S. Clinical Trial Sites for its 2024 Burn Pivotal Study, bringing the total to 16 sites including burn centers and Emergency Departments. The new sites are:
- University Medical Center Burn Center at Texas Tech University Health Sciences Center
- Tampa General Hospital Burn Center
- University of South Alabama Health Emergency Department
The study aims to validate the AI-driven algorithm used by Spectral AI's DeepView™ System for burn indication. It's expected to be the final clinical trial before seeking FDA approval in 2025. The DeepView™ System uses multispectral imaging and a database of over 340 billion clinically validated data points to provide rapid, objective burn wound assessments.
Spectral AI (Nasdaq: MDAI), an AI company focused on medical diagnostics for wound care, has provided an update on its efforts to expose potential market manipulation of its common stock, primarily through naked short selling. The company's largest shareholder, Erich Spangenberg, sent letters to Nasdaq and state securities authorities in Florida, Louisiana, and Texas on June 24, 2024, highlighting potential violations of Nasdaq rules and federal and state laws. A follow-up letter dated July 15, 2024, urges authorities to investigate the likely prevalence of naked short selling affecting MDAI shares and other de-SPAC transaction companies. The company has filed these letters via Form 8-K with the SEC, making them publicly available.
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