Spectral AI, Inc., an artificial intelligence (AI) company, focuses on predictive medical diagnostics in the United States. The company offers DeepView System, which uses proprietary AI algorithms to distinguish between fully damaged, partially damaged, and healthy human tissue characteristics invisible to the naked eye at the initial time point of wound presentation; and delivers a binary prediction on the wounds capacity to heal or not heal by a specified time point in the future to assist the physician in making a more accurate, timely, and informed decision regarding the treatment of the patient’s wounds. Its system also includes MSI imaging technology, which consists of proprietary multi-spectral optics and sensors that capture injured tissue images; and AI-Burn software. Spectral AI, Inc. is headquartered in Dallas, Texas.
Spectral AI Submits New Technology Add-On Payment (NTAP) Application for DeepView™ System
Spectral AI has submitted a New Technology Add-On Payment (NTAP) application to CMS for its DeepView System, using the alternative pathway enabled by its FDA De Novo authorization and Breakthrough Device Designation.
If approved, NTAP status would generally cover approximately 65% of the technology's estimated cost, begin in October 2027, and last about three years, with a CMS determination expected in August 2027.
Management frames the application as a key step to reduce hospital adoption barriers and support the commercialization of DeepView, a multispectral imaging AI device for burn-wound healing assessment.