DeepHealth Receives FDA Clearance for Chest X-Ray AI Solution

DeepHealth has received US Food and Drug Administration (FDA) 510(k) clearance for Chest XRay, a computer-aided detection solution that uses a proprietary foundation model to identify and localize suspected thoracic abnormalities on chest radiographs.

The company described Chest XRay as one of the first FDA-cleared chest radiography solutions developed using a foundation model. Broadly trained on large volumes of chest X-ray images, the underlying model learns visual patterns and relationships that can support the development of additional findings and workflow capabilities.

Chest XRay detects and localizes four categories of thoracic findings: pulmonary nodules, consolidation, mediastinal and hilar abnormalities, and pleural space abnormalities such as pneumothorax.

The same foundation model is used in the CE-marked version of Chest XRay available in Europe, where it analyzes more than 2.8 million examinations annually, according to DeepHealth’s internal 2026 deployment data.

“Foundation models are important building blocks,” said Sham Sokka, chief operating and technology officer at DeepHealth. “This clearance marks an important step in DeepHealth’s vision of bringing intelligence into every stage of the imaging experience.”

Niccolò Stefani, MD, business and product leader for clinical AI at DeepHealth, said the technology is intended to support radiologists in both routine interpretation and urgent care settings by bringing clinically relevant information forward when it can help inform the next step in patient care.

The newly cleared product represents the next generation of technology acquired from Gleamer. Previously cleared under the name ChestView, the software is now marketed as Chest XRay and retains ChestView’s authorized capabilities.

Chest XRay is commercially available in the United States and Europe, and existing customers are eligible for the update. The software is manufactured by Gleamer SAS and distributed by DeepHealth. It is part of the company’s Radiology AI Suite, which includes clinical AI and workflow applications for breast, neurological, thoracic, musculoskeletal, thyroid, prostate, abdominal, and pelvic imaging.