FDA Clears DeepHealth Chest X-Ray AI Software Built on a Foundation Model

The FDA has cleared Chest XRay, DeepHealth's artificial intelligence software for detecting and localizing abnormalities on chest X-rays, Diagnostic Imaging reported on September 18. DeepHealth said the product is one of the first AI platforms created from a foundation model to receive FDA 510(k) clearance for adjunctive chest X-ray assessment.

The agency's 510(k) database lists the clearance as K252486, for a device named ChestView US (1.1). The submission was received on August 7, 2025, and found substantially equivalent on September 9, 2026. The record names Gleamer, of Paris, as the applicant.

What the software does

According to DeepHealth, as reported by Diagnostic Imaging, the software can help detect and localize thoracic abnormalities including lung nodules, mediastinal abnormalities, consolidation and pneumothorax. It is offered through DeepHealth's Radiology AI Suite. A foundation model is an AI model trained broadly on a large volume of data, in this case chest X-ray images, which can then be adapted for specific tasks.

"Foundation models are important building blocks," Sham Sokka, DeepHealth's chief operating and technology officer, said, according to Diagnostic Imaging. He added that the product shows how such a model "can be translated into a precise, FDA-cleared clinical capability today, while establishing a platform for additional intelligent interactive experiences over time."

The device is classified under the medical image analyzer regulation, 21 CFR 892.2070, product code MYN, and was reviewed by the radiology panel as a traditional 510(k). The record shows that a predetermined change control plan was authorized, which allows specified changes to be made after clearance under a plan the FDA has reviewed in advance. The release coverage did not describe the performance data submitted to the agency.

Background

ChestView is the name Gleamer used for its earlier chest X-ray product. In a March 2025 announcement, Gleamer said ChestView had received FDA clearance as a computer-aided detection (CADe) model able to detect multiple findings at once and highlight regions of interest on the image. It was the company's second US clearance after its BoneView fracture-detection software in April 2022, Gleamer said at the time. The company, founded in 2017, said then that its products had analysed 35 million exams across more than 2,000 institutions in 45 countries, and that the US already contributed 30% of the company's revenue from BoneView.

The September clearance does not by itself show how the new version's performance compares with the earlier ChestView product; neither the FDA database entry nor the published coverage gave sensitivity or specificity figures.

DeepHealth did not disclose pricing in the coverage, and Diagnostic Imaging did not report a commercial launch date.