MASHINIi

Spectral AI, Inc..

MDAI.US | Manufacture of irradiation, electromedical and electrotherapeutic equipment

Spectral AI, Inc. is a medical technology company focused on developing and commercializing its DeepView® System. This system is designed to provide clinicians with a diagnostic tool that uses non-invasive spectral imaging coupled with artificial intelligence (AI) algorithms to assess burn wounds an...Show More

Ethical Profile

Mixed.

Spectral AI, Inc. (MDAI.US) demonstrates a positive impact on healthcare with its DeepView System, an AI tool for burn assessment. In a validation study, the system achieved 86.6% image-wise sensitivity in identifying non-healing tissue, outperforming physician assessment (40.8%). The company has submitted an FDA application for DeepView, developed using 340 billion data points, and holds a BARDA contract to potentially distribute 200 devices to US burn centers. However, its "Mixed" ethical rating reflects a reported lack of public data on fair pay, worker respect, ethical sourcing, specific measures for data privacy and AI ethics, planet-friendly practices, and community engagement.

Value Scores

Better Health for All0
-100100
Fair Money & Economic Opportunity0
-100100
Fair Pay & Worker Respect0
-100100
Fair Trade & Ethical Sourcing0
-100100
Honest & Fair Business-50
-100100
Kind to Animals-50
-100100
No War, No Weapons-30
-100100
Planet-Friendly Business0
-100100
Respect for Cultures & Communities0
-100100
Safe & Smart Tech0
-100100
Zero Waste & Sustainable Products0
-100100

Better Health for All

0

The DeepView System, the company's principal product, is a non-invasive AI-driven diagnostic tool that provides objective, real-time predictions of wound healing potential for burns and diabetic foot ulcers.

1
Clinical trials show it achieves 92% accuracy for identifying non-healing burn regions in adults (compared to 50-75% for physicians) and 86% accuracy for DFUs (compared to 50% for physicians).
2
This enables faster, more informed treatment decisions, earlier interventions, and reduced unnecessary procedures, aiming to significantly improve patient outcomes and streamline healthcare workflows. The system is non-invasive, non-radiation, and non-laser, with no reported safety incidents.
3
The DeepView System is expected to reduce healthcare costs by an estimated ~$24,000 per burn stay and ~$63,100 per DFU stay, but pricing for components will be strategically set, and the company acknowledges it may not achieve satisfactory pricing and margins.
4
The company has achieved 100% pediatric patient enrollment in its pivotal U.S. burn study and plans to distribute approximately 200 devices to burn centers across the U.S. via government pathways.
5
The company's disclosures include forward-looking statements and risks associated with regulatory processes, third-party suppliers, and AI technology.
6
The company has received approximately $279.6 million in government funding since 2013, including up to $150.0 million from BARDA, and is devoting substantially all efforts to R&D.
7
The DeepView System aims to improve emergency care and mass casualty preparedness, and its use in DFUs can lead to quicker advanced therapy.
8
The company trains employees in data protection, uses two-factor authentication, and does not share data externally, but acknowledges risks of data breaches.
9
The company has received substantial support from BARDA for its burn application, aiming to make the U.S. better prepared for mass casualty events.
10
The company plans to educate key opinion leaders and clinicians about the system's benefits.
11
The company conducts clinical studies across multiple sites in the U.S. and Ireland, enrolling hundreds of adult and pediatric patients, and has received ISO 13485:2016 certification for Medical Devices.
12

Fair Money & Economic Opportunity

0

MDAI.US (Spectral AI, Inc.) is a medical technology company focused on developing and commercializing its DeepView® System for burn wound assessment.

1
The company's core business does not involve lending, insuring, moving, or storing money for consumers.
2
Therefore, all KPIs under the 'Fair Money & Economic Opportunity' value, which are designed for financial institutions, are not applicable. There is no evidence in the provided articles that MDAI.US offers consumer credit products, manages customer finance data, operates financial service access points, or engages in any activities related to financial inclusion or literacy.
3

Fair Pay & Worker Respect

0

The company's overall employee rating from 18 anonymous reviews on Glassdoor is 3.2 out of 5 stars, which translates to 64% engagement.

1
Additionally, 52% of employees would recommend working at Spectral MD to a friend, and 56% rate the business outlook positively.
2
There are no explicit mentions of regulatory actions, violations, fines, or compliance issues related to labor laws or human rights in the provided articles. No specific data is available for living wage coverage, CEO-to-median employee pay ratio, collective bargaining share, safety incident rate, pay equity ratio, voluntary employee turnover rate, insecure contract share, or health insurance coverage.

Fair Trade & Ethical Sourcing

0

No evidence available to assess Spectral AI, Inc. on Fair Trade & Ethical Sourcing.

Honest & Fair Business

-50

Spectral AI has a reporting system with an effective whistleblower protection mechanism as part of its Compliance Officer's duties, but specific details on its implementation, such as independent investigation processes or training, are not provided.

1
The company identified material weaknesses in its internal control over financial reporting as of December 31, 2023, including a lack of communication within management, inadequate controls for recording operating expenses and unbilled revenue, and issues with its financial statement close process controls.
2
The company is subject to anti-corruption regulations like the FCPA and UK Bribery Act, and has a Code of Business Conduct and Ethics, but the articles do not detail the strength or enforcement of its internal policy or training frequency.
3
The company received ISO 13485:2016 certification for Medical Devices in 2023, with the certification audit completed in Q1 2024 without exceptions, and performs regularly scheduled visits and inspections with its contract manufacturer in accordance with federally mandated and ISO standards.
4

Kind to Animals

-50

MDAI.US conducts pre-clinical studies on animals to assess product safety, with the company stating in a report that they exploit animals for product testing.

1
Their DeepView device was used in animal studies to differentiate viable tissue from burn tissue.
2
The company uses 15,000–25,000 animals per year for testing, including dogs and primates, with no transparent reduction targets mentioned.

No War, No Weapons

-30

Spectral AI is developing the DeepView SnapShot M device for military field use, specifically for battlefield burn assessment.

1
The company has received significant funding from government contracts, including approximately $281.5 million since 2013, with $272.9 million from BARDA.
2
Specific defense-related contracts include a $1.1 million contract from the US Department of Defense, a $0.5 million award from the Defense Health Agency in March 2024, and over $6 million total for the DeepView SnapShot M from the Defense Health Agency and US Army Medical Material Development Activity.
3
The DeepView SnapShot M is considered a dual-use technology, as it is being developed for military use but Spectral AI believes its potential applications can extend to first responders and other healthcare providers.
4

Planet-Friendly Business

0

No specific, quantifiable environmental performance data for MDAI.US (Spectral AI, Inc.) was found in the provided articles. The articles discuss general industry trends, future plans of a partner (RAI Amsterdam), or refer to a different entity named Spectral Capital.

1

Respect for Cultures & Communities

0

No specific, concrete evidence was found in the provided articles to assess MDAI.US against any of the KPIs for 'Respect for Cultures & Communities'. The articles primarily focus on financial performance, product development, regulatory approvals, and general employee training (data protection, cybersecurity), rather than community engagement, cultural impact, or related initiatives. While employee training on data protection and cybersecurity is mentioned,

1
there is no evidence of cultural sensitivity training.

Safe & Smart Tech

0

The provided articles discuss general concepts and industry trends related to data breaches, AI ethics, cybersecurity, and privacy. They mention the importance of ethical AI development, data breach prevention, and regulatory compliance, and cite examples of data breaches at other companies.

1
However, none of the articles provide specific, quantitative evidence or concrete facts about MDAI.US's actual performance, policies, or actions regarding any of the KPIs in the rubric. Therefore, no KPIs can be scored based on the provided information.

Zero Waste & Sustainable Products

0

No specific, concrete data points or actions related to MDAI.US's waste management, product recyclability, packaging sustainability, or any other KPI under 'Zero Waste & Sustainable Products' were found in the provided articles.

1
The articles discuss general trends in waste management, recycling, and the role of AI in these areas, but do not link this information to MDAI.US's operations or products, which are focused on medical technology for burn wound assessment.
2

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AI-generated analysis based on publicly available data. Not financial advice. Ratings are expressions of opinion derived from automated models and may contain inaccuracies. See our Risk Disclosure for full details.