Spectral AI Outlines U.S. Regulatory Pathway for DeepView® System for Burn Indication
Spectral AI, Inc. - Class A (MDAI)
Company Research
Source: GlobeNewswire
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”). DeepView AI®-Burn, which received Breakthrough Device Designation from the U.S. Food and Drug Administration (“FDA”) in 2018, is a predictive medical device that assesses the healing potential of burns by combining multi-spectral 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 that can support clinical decision-making regarding next step treatment
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MDAI
News
- Spectral AI Achieves 25% Patient Enrollment at Emergency Departments for U.S. Burn Pivotal Study and Adds Two New Clinical Trial SitesGlobeNewswire
- American Burn Association Study Highlights Inequities in Access to Specialized Burn CareGlobeNewswire
- Spectral AI Awarded Additional Funding from Medical Technology Enterprise Consortium to Support Ongoing Development of DeepView SnapShot M®GlobeNewswire
- Spectral AI to Participate in Upcoming Investor ConferencesGlobeNewswire
- Spectral AI Completes Burn Center Enrollment for U.S. Burn Pivotal StudyGlobeNewswire
MDAI
Earnings
- 8/12/24 - Miss
MDAI
Sec Filings
- 8/13/24 - Form 8-K
- 8/12/24 - Form 10-Q
- 7/15/24 - Form 8-K
- MDAI's page on the SEC website