FDA 510(k) Clearance for Chest XRay
RadNet subsidiary DeepHealth has received 510(k) clearance from the U.S. Food and Drug Administration for Chest XRay, an AI-powered chest X-ray solution designed to detect and localize suspected thoracic abnormalities on radiographs.
The software is built on a foundation model trained across large volumes of chest images. DeepHealth says the approach is intended to support current computer-aided detection capabilities and provide a foundation for developing additional findings and workflow tools.
The same underlying model is already used in Europe through the CE-marked version of Chest XRay. According to the company, the model analyzes more than 2.8 million examinations annually in Europe.
Sham Sokka, PhD, RadNet's chief operating and technology officer, digital health, states: “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, while establishing a platform for additional intelligent interactive experiences over time. This clearance marks an important step in DeepHealth’s vision of bringing intelligence into every stage of the imaging experience.”
Thoracic Findings
Chest XRay is designed to identify and localize four categories of thoracic findings on chest radiographs: nodules, consolidation, mediastinal and hilar abnormalities, and pleural space abnormalities, including pneumothorax.
The software is intended to support radiologists across routine chest X-ray interpretation as well as more urgent exams by flagging suspicious findings for further review.
“This clearance advances our vision for an intelligent experience that helps move patients more efficiently from exam to informed action,” said Niccolò Stefani, MD, business and product leader, clinical AI, at DeepHealth. “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.”
DeepHealth Radiology AI Suite
The software is part of DeepHealth’s Radiology AI Suite, which includes clinical AI and workflow applications spanning breast, neurological, thoracic, musculoskeletal, thyroid, prostate, abdominal and pelvic imaging.
The clearance adds a U.S. FDA-cleared version of Chest XRay to DeepHealth’s existing European CE-marked offering, with the software covering four categories of thoracic findings and intended for use in routine and more urgent chest X-ray interpretation.
Source: DeepHealth
