Canadian AI software developer 16 Bit has received de novo approval from the U.S. Food and Drug Administration (FDA) for Rho, an AI tool for evaluating low bone mineral density (BMD).
Rho uses patented AI technology to automatically scan standard x-rays (frontal projections of the chest, thoracic spine, lumbar spine, pelvis, knee, and hand/wrist) for markers of low BMD, an indicator of osteoporosis, 16 Bit said.
The software could improve screening for osteoporosis, as screening rates using dual energy x-ray absorptiometry scans are low in the U.S., the company noted.
![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)
