DeepHealth Receives FDA Clearance for Foundation Model-Based Chest X-Ray AI Solution

DeepHealth has announced FDA 510(k) clearance for Chest XRay, one of the first FDA-cleared chest X-ray computer-aided detection (CADe) solutions built on a foundation model that detects and localizes suspected thoracic abnormalities on chest radiographs. The clearance marks a significant step in the company’s vision of bringing intelligence into every stage of the imaging experience.

The Chest XRay foundation model is broadly trained to learn visual patterns and relationships across large volumes of chest X-ray images, designed to accelerate the development of additional findings and workflow capabilities. The same underlying model is already used by European customers through the CE-marked Chest XRay, which analyzes more than 2.8 million examinations annually. The newly cleared version is the next evolution of acquired Gleamer technology.

Chest XRay is designed to support interpretation by detecting and localizing four categories of thoracic findings: nodules, consolidation, mediastinal and hilar abnormalities, and pleural space abnormalities such as pneumothorax, in which air around the lung can cause it to collapse. Chest XRay is now commercially available in the United States and Europe, and all existing customers are eligible for the update. The solution is part of Radiology AI Suite, DeepHealth’s comprehensive portfolio of native clinical AI and workflow solutions spanning breast, neurological, thoracic, musculoskeletal, thyroid, prostate, abdominal, and pelvic imaging. Together, these solutions connect clinical and operational AI across core imaging modalities in one platform to support a more integrated and intelligent imaging experience.

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