One of the first FDA-cleared chest X-ray solutions built on a foundation model enables accelerated development of new capabilities
DeepHealth announces FDA 510(k) clearance for Chest XRay,¹ 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 Chest XRay foundation model is broadly trained to learn visual patterns and relationships across large volumes of chest X-ray images and is 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.2
“Foundation models are important building blocks,” said Sham Sokka, 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. This clearance marks an important step in DeepHealth’s vision of bringing intelligence into every stage of the imaging experience.”
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.
“This clearance advances our vision for an intelligent experience that helps move patients more efficiently from exam to informed action,” said Niccolò Stefani, M.D., Business and Product Leader, Clinical AI at DeepHealth. “Chest XRay supports radiologists across the volume of everyday interpretation and the urgency of high-impact acute care, bringing clinically relevant information forward when and where it can help shape the next step of a patient’s care journey.”
The newly cleared version of Chest XRay is the next evolution of acquired Gleamer technology. Chest XRay is now commercially available in the U.S. and Europe, and all existing customers are eligible for the update.
Chest XRay 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.
References
- The cleared software previously known as ChestView is now marketed as Chest XRay. Chest XRay retains the cleared capabilities of ChestView and serves as the foundation for ongoing innovation, with additional features and enhancements being introduced over time. Chest XRay is manufactured by Gleamer, SAS and distributed by DeepHealth, Inc.
- Based on DeepHealth internal deployment data, 2026.
