AZmed

Deep learning detection on plain radiographs is the entire company. The Rayvolve suite comprises AZtrauma and AZchest modules that read X-rays and return findings to the interpretation console, with no hardware, PACS, or services layer sold alongside. The company was founded in 2018 around this single technical proposition and has expanded by adding anatomical coverage rather than adjacent business lines.

Detection presented into the clinician's existing interpretation console, with the reader retaining the diagnosis. The design emphasis is explicitly on requiring no change in work habits, which is a deliberate low friction posture rather than an autonomy claim. The reader studies underpinning clearance measure performance WITH and WITHOUT the tool, which is the correct framing for an assistive device and implies the human remains the decision maker by design rather than by disclaimer.

Performance is published with unusual specificity for a company this size, and importantly it is reported as reader improvement rather than standalone algorithm accuracy. The University Hospitals Cleveland study reports sensitivity rising from 0.865 to 0.955 and specificity from 0.826 to 0.831 with AI assistance, accuracy improving 5.6 percent, and interpretation time falling 27 percent. The pediatric study reports 96 percent sensitivity, 86 percent specificity, and AUC of 94 percent across 3,000 radiographs. Publishing the specificity figure that barely moved, alongside the sensitivity figure that moved a lot, is a more honest presentation than most vendors offer. Model architecture and training data composition are not published.

Validation is externally generated rather than vendor run, which is the distinguishing feature. The adult clearance rested on a study at University Hospitals in Cleveland where board certified musculoskeletal radiologists read and annotated 2,626 X-rays of patients at four UH sites. The pediatric clearance rested on an independent study with SimonMed Imaging, one of the largest US outpatient imaging providers, across 3,000 pediatric radiographs. A 2026 study by Cohen and colleagues evaluated the suite across 258,373 X-rays from 100 clinical centers in 26 countries, which is a scale of multi-site evaluation few vendors in this index can match. Separate published work covers external validation in children and thoracic pathology detection. Deployment spans a reported 2,000 plus facilities.

No specific PHI handling or data governance framework was located in the materials reviewed.

No HIPAA or BAA commitment was located. A France headquartered vendor selling into US emergency departments and imaging centers should be asked to establish business associate terms and confirm processing location.

No SOC 2, ISO 27001, or equivalent attestation and no trust center were located in the materials reviewed.

Multiple current US clearances across two anatomical domains: adult fracture detection cleared 2022, pediatric fracture detection cleared September 2024, and two further clearances for AZchest covering lung nodule interpretation plus pneumothorax and pleural effusion triage. The company states AZtrauma is the only FDA cleared solution in the United States covering fractures, joint effusions, and dislocations together, a scope claim worth verifying against a buyer's specific indications. CE marked since 2021. Both fracture clearances were supported by named external institutional studies rather than vendor internal data, which strengthens the regulatory record.

Stronger than most, expressed through validation breadth rather than a governance programme. The 2026 Cohen study spanning 258,373 X-rays across 100 centers in 26 countries directly tests generalization across geography, equipment, and practice patterns, which is the failure mode most imaging AI never examines publicly. Separate validation in a pediatric population addresses a distinct physiological group rather than assuming adult performance transfers. What is absent is a formal governance framework, post market monitoring commitment, or demographic subgroup breakdown.

Results are delivered directly into the clinician's existing interpretation console with the explicit design goal of requiring no workflow change, and the suite is integrated into third party cloud radiology workflow platforms including RADIN. Deployment across a reported 2,000 plus facilities in more than 20 countries implies the integration is genuinely portable across varied PACS environments rather than bespoke. This is radiology workflow integration; no EHR integration is claimed or applicable.

Multiple delivery paths exist, direct deployment and distribution through cloud based radiology workflow platforms, which gives buyers routes but also means residency depends on which path is chosen. Specific tenancy, hosting, and data residency terms are not published, a live question for a European vendor processing US patient imaging.

No pricing is published. The company reports scale, more than 2,000 facilities and 2,500 plus radiologists and emergency physicians using the software in clinical routine across 21 or more countries, but no per exam, per site, or licensing rates. Availability through partner radiology platforms creates a second procurement route with likely different economics, also undisclosed.

Concentrated on plain radiography across two domains: musculoskeletal trauma covering fractures, joint effusions, and dislocations for both adults and children, and thoracic covering lung nodules plus pneumothorax and pleural effusion triage. Read by radiologists and emergency physicians in emergency, trauma, and outpatient imaging settings. Deliberately X-ray centric rather than spanning CT and MRI, which distinguishes it from multimodality platforms, though the pediatric plus adult clearance combination gives it unusual population breadth within that scope.