DeepHealth has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Chest XRay, a computer-aided detection (CADe) tool built on a foundation model that detects and localizes suspected thoracic abnormalities on chest radiographs.
Chest XRay is designed to detect and localize four categories of thoracic findings: nodules, consolidation, mediastinal and hilar abnormalities, and pleural space abnormalities including pneumothorax, according to the vendor. The underlying foundation model is already used by European customers through the CE-marked version of Chest XRay, which analyzes more than 2.8 million exams annually, DeepHealth said.
The newly cleared version is built on technology acquired from Gleamer and is now commercially available in the U.S. and Europe, with existing customers eligible for the update.
