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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News
- Spectral AI Announces DeepView SnapShot® M Moves Forward with Feedback from Brooke Army Medical Center Institute of Surgical ResearchGlobeNewswire
- Spectral AI Raises Up to $5 Million Financing Strengthening Financial Position for FDA PathwayGlobeNewswire
- Spectral AI Announces 2024 Third Quarter Financial ResultsGlobeNewswire
- Spectral AI Announces Plan to Spin Off Spectral IP Subsidiary Focused on Intellectual Property Investments and MonetizationGlobeNewswire
- Spectral AI Announces Last Patient Out in U.S. Burn Pivotal Study at Burn CentersGlobeNewswire
MDAI
Earnings
- 11/6/24 - Beat
MDAI
Sec Filings
- 11/21/24 - Form S-3
- 11/18/24 - Form 424B5
- 11/14/24 - Form SC
- MDAI's page on the SEC website