The expanded FDA clearance for AZtrauma adds detection of joint effusions and dislocations across adult and pediatric populations and broadens the scope of the company’s X-ray AI suite.
RADIN Health and AZmed announced an expansion of their strategic partnership following a new US Food and Drug Administration (FDA) clearance for the Rayvolve AI Suite’s AZtrauma module.
According to the companies, the expanded clearance broadens the module’s capabilities beyond fracture detection to include detection of joint effusions and dislocations on X-rays in adult and pediatric patients ages 2 and older.
AZmed says the clearance makes AZtrauma the only FDA-cleared AI solution in the United States covering fractures, joint effusions, and dislocations on X-rays.
The announcement follows publication of a 2026 study by Cohen et al, which evaluated the company’s X-ray AI suite using 258,373 X-rays collected from 100 clinical centers across 26 countries.
The Rayvolve AI Suite modules, including AZtrauma and AZchest for thoracic abnormality analysis and triage, are integrated into RADIN’s cloud-based radiology workflow platform.
“Our north star at RADIN is to eliminate every single disruption in radiology workflow,” said Dr Alejandro Bugnone, musculoskeletal radiologist and CEO of RADIN Health, in a release. “AZmed’s investment allows us to consistently and immediately identify and triage fractures, joint effusions, and dislocations across adult and pediatric populations before the radiologist ever opens the study.”
RADIN says its platform processes imaging studies and related clinical documents, including DICOM structured reports and OCR-processed handwritten materials, to support workflow and reporting efficiency. The company also said its AI-assisted dictation tools can help accelerate structured report generation.
According to the companies, customers including Total Medical Imaging are using AZtrauma and AZchest in clinical workflows for study prioritization and image review.
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