FDA clears DeepHealth chest X-ray AI built on a foundation model
DeepHealth, a RadNet company, received FDA 510(k) clearance for Chest XRay, formerly ChestView. The computer-aided detection tool finds and localizes suspected lung nodules, consolidation, mediastinal and hilar abnormalities, and pleural abnormalities including pneumothorax. It is reported to be one of the first FDA-cleared chest X-ray AI products built on a foundation model. The company says the CE-marked European version analyzes more than 2.8 million exams a year.
Why it's notable: Foundation-model imaging AI can add new findings faster than single-purpose algorithms. This clearance shows the FDA is accepting that design for one of the most common exams in medicine.