Spectral AI Applies for Medicare Add-On Payment for Its DeepView Burn Assessment System

Spectral AI, Inc. (NASDAQ: MDAI), a Dallas-based artificial intelligence company focused on wound care diagnostics, announced on October 6, 2026 that it has submitted a New Technology Add-On Payment (NTAP) application to the Centers for Medicare & Medicaid Services (CMS) for its DeepView System. The company filed under the alternative pathway. If approved, the program would provide hospitals with an additional inpatient Medicare payment for eligible cases that use the device.

What an NTAP Approval Would Mean

CMS designed the NTAP program to help hospitals cover the added cost of bringing new technologies into patient care. According to Spectral AI, the additional payment is generally limited to approximately 65% of the estimated cost of the new technology, subject to CMS requirements and payment limits.

The company expects a final determination from CMS in August 2027. If approved, NTAP status would generally become available starting in October 2027 and continue for approximately three years. “An NTAP payment, if approved, would represent a meaningful component of the economic value proposition for hospital systems that adopt the DeepView System,” said CEO Vincent Capone.

How DeepView Works

DeepView is a non-invasive device that pairs multispectral imaging with a proprietary AI algorithm to assess the healing potential of areas within burn wounds. In particular, it identifies areas that are unlikely to heal within 21 days and may need significant medical intervention. In May 2026, the FDA granted De Novo Classification to the system, which authorized Spectral AI to begin commercial distribution in the United States.

Image acquisition takes 0.2 seconds, and processing and AI classification take approximately 20 to 25 seconds. Spectral AI trained and tested the system against a proprietary, clinically validated database of more than 340 billion pixels of burn wound image data. The device also holds Breakthrough Device Designation, which the company said enabled it to pursue additional reimbursement pathways.

Building Toward First Commercial Sales

In its second-quarter update, Spectral AI said it is targeting first commercial sales of the DeepView System in the U.S. by year end 2026. Research and development revenue for the quarter was $3.5 million, compared with $5.1 million a year earlier. The company attributed the decline mainly to reduced reimbursed costs under its BARDA Project BioShield contract following FDA clearance. Meanwhile, net loss narrowed to $4.2 million from $8.0 million, and cash and cash equivalents stood at $14.0 million on June 30.

Earlier in 2026, Spectral AI secured a $31.7 million advanced funding award from BARDA and drew $6.5 million under its credit facility with Avenue Capital Group. More recently, on October 1, the company completed the first site initiation visit for a UK clinical study supporting a label expansion to burns of the head, hands and feet.

Strategic Investment Summary

• NTAP Application: Spectral AI, Inc. (NASDAQ: MDAI) submitted an NTAP application to CMS for its DeepView System under the alternative pathway.
• Potential Payment: NTAP payments are generally limited to approximately 65% of the estimated cost of the new technology.
• Timeline: The company expects a CMS decision in August 2027, with payments generally available from October 2027 for about three years if approved.
• FDA Status: DeepView received De Novo Classification in May 2026, authorizing U.S. commercial distribution.
• Financial Position: Second-quarter R&D revenue was $3.5 million, net loss narrowed to $4.2 million, and cash stood at $14.0 million on June 30.
• Commercial Target: Spectral AI is targeting its first U.S. commercial sales of DeepView by year end 2026.

Find out more about the latest corporate developments and financial reports at the Spectral AI investor portal.