Welcome to our dedicated page for Spectral AI news (Ticker: MDAIW), a resource for investors and traders seeking the latest updates and insights on Spectral AI stock.
Spectral AI Inc is an AI company, focused on predictive medical diagnostics. Spectral is devoting substantially all of its efforts towards the research and development of its DeepView System, an internally developed MSI device that has designated FDA BDD status. Its DeepView System uses proprietary algorithms to distinguish between damaged and healthy human tissue invisible to the naked eye, providing Day One healing assessments in seconds. The Company's output is specifically engineered to allow the physician to make a more accurate, timely, and informed decision regarding the treatment of the patient's wound.
Latest News: DALLAS, April 30, 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 received the Commitment to Quality Achievement Award from the Texas Manufacturer Assistance Center (TMAC) for their UKCA Mark Attainment. “Spectral AI is honored to be recognized as an upcoming leader in the Texas Manufacturing space,” said Louis Percoco, Spectral AI’s General Manager. “Our mission is to bring innovation and solutions to wound care through the company’s DeepView™ technology with the utmost quality and a strong manufacturing backbone is vital as we continue driving towards commercialization of the product. We are proud to be part of the local business infrastructure and appreciate the support and recognition for the focus the team brought to the table by the Texas manufacturing community.” TMAC, which is associated with the Manufacturing Extension Partnership (MEP) of the National Institute of Standards and Technology (NIST) aims for Texas manufacturers to achieve profitable growth and increased competitiveness. The non-profit program supports Texas manufacturers by granting business management consulting services, new technologies implementation, operations streamlining, workforce development, and strategic planning. Their services extend beyond manufacturers and also include distribution, logistics, construction, healthcare, and government entities. This award heralds in a new era of quality excellence and leadership for Spectral AI as they move toward product commercialization.
Spectral AI (Nasdaq: MDAI) has outlined its regulatory strategy to enter the U.S. market with DeepView AI®-Burn, a predictive medical device for burn assessment. The company plans to pursue a De Novo submission to the FDA, requesting classification as a Class II medical device. This decision is based on the unique characteristics of DeepView AI®-Burn, which received Breakthrough Device Designation in 2018.
The device combines multi-spectral imaging with AI to assess burn healing potential, trained on over 340 billion clinically validated data points. Spectral AI expects to submit the De Novo request in Q2 2025. The company recently completed patient enrollment for its U.S. Burn Pivotal Study, marking a significant milestone in its development process.
Spectral AI (Nasdaq: MDAI) highlights a study by the American Burn Association (ABA) revealing inequities in access to specialized burn care. The study shows rural and pediatric patients face significant barriers to timely treatment. Key findings include:
1. Pediatric patients travel 30.5 miles further than adults to burn centers, increasing transport costs.
2. Rural patients face 50.02% longer travel distances and nearly double transportation costs.
3. Mountain West and Southeastern U.S. have critically low access to burn centers.
Spectral AI's DeepView® System aims to address these disparities by providing rapid, objective burn wound assessments. The company recently completed enrollment for its U.S. Burn Pivotal Study and plans to submit a De Novo classification request to the FDA in Q2 2025.
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.
FAQ
What is the current stock price of Spectral AI (MDAIW)?
What is Spectral AI focused on?
What is the significance of the DeepView System?
What recent achievement did Spectral AI have?
Who is Louis Percoco?
What does TMAC aim to achieve?
