DeepHealth Gains FDA Clearance for Chest XRay CADe Solution

DeepHealth announced that it has received FDA 510(k) clearance for Chest XRay, a chest X-ray computer-aided detection (CADe) solution that identifies and localizes suspected thoracic abnormalities in chest radiographs.

The Chest XRay foundation model utilizes extensive training to recognize visual patterns and relationships present in large datasets of chest X-ray images, facilitating the future development of enhanced findings and workflow features. This foundation model is already operational in Europe through the CE-marked Chest XRay, which performs analysis on over 2.8 million examinations annually.

Sham Sokka, Chief Operating and Technology Officer at DeepHealth, emphasized the significance of foundation models, stating, "Foundation models are important building blocks. Chest XRay demonstrates how a broadly trained foundation model can be translated into a precise, FDA-cleared clinical capability today... This clearance marks an important step in DeepHealth’s vision of bringing intelligence into every stage of the imaging experience."

The Chest XRay solution aids in the interpretation of four types of thoracic findings: nodules, consolidation, mediastinal and hilar abnormalities, and pleural space abnormalities, including pneumothorax, which can lead to lung collapse due to air accumulation around it.

Dr. Niccolò Stefani, Business and Product Leader for Clinical AI at DeepHealth, noted that the clearance enhances the company’s mission for an intelligent experience, stating, "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 represents an advancement from the previously acquired Gleamer technology. It is now available commercially in the U.S. and Europe, with all existing customers eligible for the updated version.

Chest XRay is part of Radiology AI Suite, DeepHealth’s extensive collection of clinical AI and workflow solutions that encompass various imaging domains, including breast, neurological, thoracic, musculoskeletal, thyroid, prostate, abdominal, and pelvic imaging. These solutions integrate clinical and operational AI across core imaging modalities to enhance the imaging experience.

The software that was formerly known as ChestView is now marketed as Chest XRay, retaining its cleared capabilities while serving as a basis for future innovations, with additional features and enhancements planned for subsequent updates. Chest XRay is manufactured by Gleamer, SAS and distributed by DeepHealth, Inc.