News|Videos|September 18, 2026

Foundation Model-Based Chest X-Ray AI Software Gets FDA Nod

Author(s)Jeff Hall

Reportedly one of the first FDA-cleared chest X-ray AI software platforms derived from a foundation model, the Chest Xray software facilitates detection and localization of lung nodules, pneumothorax, mediastinal abnormalities and other thoracic abnormalities.

The Food and Drug Administration (FDA) has issued a 510(k) clearance for the AI-powered Chest XRay software, which may enhance detection of thoracic abnormalities.

Trained on a large volume of chest X-ray images, the Chest XRay software is one of the first AI platforms created from a foundation model to achieve FDA clearance for adjunctive chest X-ray assessment, according to DeepHealth, the developer of the software.

Available through DeepHealth’s Radiology AI Suite, DeepHealth said the Chest XRay software may aid in detecting and localizing thoracic abnormalities ranging from lung nodules and mediastinal abnormalities to consolidation and pneumothorax.

“Foundation models are important building blocks,” said Sham Sokka, the chief operating and technology officer at DeepHealth. “Chest XRay demonstrates how a broadly trained foundation model can be translated into a precise, FDA-cleared clinical capability today, while establishing a platform for additional intelligent interactive experiences over time.”


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