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FDA De NovoFDA De Novo. Stage 4 of 4 (Authorized)

FDA Grants De Novo to Spectral AI's DeepView System for Burn Wound Assessment

The multispectral imaging and AI device predicts which areas of a burn are unlikely to heal within 21 days, and its authorization creates a new device type.

By News DeskMay 26, 20262 min read
Exterior sign of the Grossman Burn Center at Sherman Oaks Hospital
The Grossman Burn Center at Sherman Oaks Hospital in California, a type of setting the DeepView System is intended for. The center is not named in Spectral AI's announcement. Cbl62, CC BY-SA 3.0, via Wikimedia Commons · CC BY-SA 3.0
FDA De Novonew device type · DEN250028FDA De Novo. Stage 4 of 4 (Authorized)

The FDA granted this device through the De Novo pathway, used for new low-to-moderate-risk device types with no existing equivalent.

Key points

  • FDA granted De Novo DEN250028 to the DeepView AI System on May 21, 2026; Spectral AI announced it on May 26.
  • The device combines multispectral imaging with an AI algorithm to flag burn areas unlikely to heal within 21 days.
  • Spectral AI says the decision lets it begin commercial distribution in the US for burn centers, trauma centers and emergency departments.

Spectral AI said on May 26 that the U.S. Food and Drug Administration has granted De Novo classification for its DeepView System for burn care, allowing the Dallas company to begin commercial distribution in the United States, according to its press release, distributed by GlobeNewswire and read via BiopharmaWatch.

FDA records accessed through the agency's openFDA device database list the decision as DEN250028 for the "DeepView AI® System", granted on May 21, 2026, after a request received on June 27, 2025. The new device type is classified as a software-aided adjunctive diagnostic device for use by healthcare providers in skin wound assessment, under regulation 21 CFR 878.1840, Class II, product code SHY.

How DeepView works

The company describes DeepView as a non-invasive device that combines multispectral imaging with a proprietary AI algorithm to assess the healing potential of areas within a burn wound. It gives clinicians an assessment of whether parts of a burn are unlikely to heal within 21 days and may require significant medical intervention.

According to the release, image capture takes 0.2 seconds and image processing and AI classification take about 20 to 25 seconds. Spectral AI said the system was trained and tested on a proprietary, clinically validated database of more than 340 billion pixels of burn wound image data. The release did not report the accuracy figures from the pivotal study submitted to the FDA.

The device is intended for burn care in settings including burn centers, trauma centers and emergency departments, the company said.

"Our ability to obtain FDA De Novo classification is a defining moment in Spectral AI's history," said chief executive Vincent Capone. Chairman J. Michael DiMaio said the company is "now positioned to commence commercialization of the DeepView System."

Federal funding

The DeepView program is supported in whole or in part by federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services' Administration for Strategic Preparedness and Response, under contract 75A50123C00049, according to the release.

Spectral AI, listed on Nasdaq under the ticker MDAI, did not give a price for the system or a date for first commercial sales in the announcement.

Sources

  1. openFDA device record DEN250028: DeepView AI System (Spectralmd, Inc.), U.S. Food and Drug Administration (openFDA), May 21, 2026
  2. Spectral AI Receives FDA De Novo Clearance for DeepView System for Burn Indication (GlobeNewswire release, read via BiopharmaWatch), Spectral AI (via BiopharmaWatch), May 26, 2026