Spectral AI (MDAI) Submits FDA Application for DeepView Burn Assessment System

Spectral AI, Inc. (NASDAQ:MDAI) is one of the most popular AI penny stocks to buy according to billionaires. On June 30, Spectral AI (NASDAQ:MDAI) submitted a De Novo 510k application to the FDA for its DeepView System, a non-invasive diagnostic tool that uses multispectral imaging and proprietary AI to predict burn wound healing.

Spectral AI (MDAI) Submits FDA Application for DeepView Burn Assessment System

An aesthetic doctor making use of innovative, cutting-edge medical technology in their practice.

Designed for use in emergency departments and burn centers, the system provides clinicians with same-day and week-long injury assessments to guide early treatment decisions. Due to its novel approach and lack of an existing equivalent device, the company is pursuing FDA clearance through the De Novo pathway.

Company Chairman Dr. J. Michael DiMaio called the submission a major milestone for bringing DeepView to market and improving patient outcomes. Supported in part by federal funding from BARDA and the U.S. Department of Health and Human Services, the project has received multiple development contracts since 2013, reflecting ongoing public-sector support for the technology’s advancement.

Spectral AI, Inc. (NASDAQ:MDAI) is a Dallas-based medical technology company specializing in predictive diagnostics powered by AI. Its flagship product, the DeepView System, uses proprietary AI algorithms to assess wound healing potential. The platform has received Breakthrough Device Designation from the FDA and is undergoing regulatory review.

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Disclosure: None. This article is originally published at Insider Monkey.