Mosaic Clinical Technologies' Cognita CXR, an AI model for chest x-ray interpretation, has received breakthrough device designation from the U.S. Food and Drug Administration (FDA).
The software analyzes chest x-rays and generates preliminary findings that licensed radiologists review and finalize, according to the company. Internal clinical validation showed that radiologists using Cognita CXR achieved enhanced detection ranging from 16% to 65% for certain findings and an 18% boost in average interpretation efficiency, Mosaic said.
Cognita operates as the AI business unit of Mosaic Clinical Technologies, a subsidiary of Radiology Partners.
![Representative example of a 16-year-old male patient with underlying X-linked adrenoleukodystrophy. (A, B) Paired anteroposterior (AP) chest radiograph and dual-energy x-ray absorptiometry (DXA) report shows lumbar spine (L1 through L4) areal bone mineral density (BMD). The DXA report was reformatted for anonymization and improved readability. The patient had low BMD (Z score ≤ −2.0). (C) Model (chest radiography [CXR]–BMD) output shows the predicted raw BMD and Z score in comparison with the DXA reference standard, together with interpretability analyses using Shapley additive explanations (SHAP) and gradient-weighted class activation maps. The patient was classified as having low BMD, consistent with the reference standard. AM = age-matched, DEXA = dual-energy x-ray absorptiometry, RM2 = room 2, SNUH = Seoul National University Hospital, YA = young adult.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/04/ai-children-bone-density.0snnf2EJjr.jpg?auto=format%2Ccompress&fit=crop&h=100&q=70&w=100)
![Representative example of a 16-year-old male patient with underlying X-linked adrenoleukodystrophy. (A, B) Paired anteroposterior (AP) chest radiograph and dual-energy x-ray absorptiometry (DXA) report shows lumbar spine (L1 through L4) areal bone mineral density (BMD). The DXA report was reformatted for anonymization and improved readability. The patient had low BMD (Z score ≤ −2.0). (C) Model (chest radiography [CXR]–BMD) output shows the predicted raw BMD and Z score in comparison with the DXA reference standard, together with interpretability analyses using Shapley additive explanations (SHAP) and gradient-weighted class activation maps. The patient was classified as having low BMD, consistent with the reference standard. AM = age-matched, DEXA = dual-energy x-ray absorptiometry, RM2 = room 2, SNUH = Seoul National University Hospital, YA = young adult.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/04/ai-children-bone-density.0snnf2EJjr.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
