Table 1. U.S. Food and Drug Administration-Cleared Musculoskeletal AI/Machine Learning-Enabled Medical Devices as of December 2024.
| Company | Product | Modality | Headquarter | Released | URL | Key-Features |
|---|---|---|---|---|---|---|
| Avicenna.AI | CINA-CSpine | CT | France | 2024 | https://avicenna.ai/solutions/spine/ | Detection and triage of cervical spine fractures |
| RemedyLogic | RAI | MRI | USA | 2024 | https://www.remedylogic.com/ | Spine MRI interpretation |
| Ever Fortune.AI | EFAI BAPXR | Radiography | Republic of China | 2024 | https://www.everfortuneai.com.tw/en/ | Bone age assessment |
| Rho | 16 Bit | Radiography | Canada | 2024 | https://www.16bit.ai/rho | Opportunistic screening of osteoporosis |
| ImageBiopsy Lab | LAMA | Radiography | Austria | 2023 | https://www.imagebiopsy.com/product/ib-lab-lama-fda?utm_lang=en | Length and angle measurements of the lower limb |
| Medical Metrics | Spine CAMP | Radiography | USA | 2023 | https://medicalmetrics.com/spinecamp/ | Quantitative spine measurements & motion analysis |
| SmartSoft Healthcare | CoLumbo | MR | Bulgaria | 2022 | https://columbo.me/ | Spine MRI interpretation |
| Nanox.AI | HealthOST | CT | Israel | 2022 | https://www.nanox.vision/ai-bone-solution/ | Detects vertebral compression fractures & measures bone mineral density to identify patients at risk |
| MRIguidance | BoneMRI | MR | Netherlands | 2022 | https://mriguidance.com/ | 3D CT-like image generation from MRI |
| Aidoc Medical | BriefCase for Rib Fracture Triage | CT | Israel | 2021 | https://www.aidoc.com/solutions/radiology/ | Rib fracture triage, prioritization, |
| Radiobotics | RBknee | Radiography | Denmark | 2021 | https://radiobotics.com/ | Diagnosis of OA: osteophytes, subchondral sclerosis, and joint space narrowing |
| Shanghai United Imaging Intelligence | uAI EasyTriage-Rib | CT | China | 2021 | https://eu.united-imaging.com/en/product-service/software-and-solution/software | Rib fractures (detects multiple and acute fractures) |
| Gleamer | BoneView | Radiography | France | 2020 | https://www.gleamer.ai/solutions/boneview/ | Bone trauma X-ray interpretation in various body regions |
| Imagen Technologies | FractureDetect | Radiography | USA | 2020 | https://imagen.ai/ai-software/ | Detecting hard-to-spot fractures in upper and lower extremities |
| Zebra Medical Vision | HealthVCF | CT | Israel | 2020 | http://www.zebra-med.com/ | Vertebral compression fracture detection and prioritization |
| Annalise-AI | Enterprise CXR Triage Trauma | Radiography | Australia | 2020 | https://annalise.ai | 5 acute findings: pneumothorax, tension pneumothorax, pleural effusion, pneumoperitoneum, and vertebral compression fracture |
| Aidoc Medical | BriefCase for CSF Triage | CT | Israel | 2019 | https://www.aidoc.com/solutions/radiology/ | Cervical spine fracture triage, prioritization, notification |
| AZmed | Rayvolve | Radiography | France | 2019 | https://azmed.co/ | Detecting fractures, dislocations, and joint effusions on X-rays |
| Medimaps | TBS iN (Osteo) | Radiography | Switzerland | 2019 | https://www.medimapsgroup.com/tbs-osteo/ | Bone microarchitecture (trabecular bone score) computing |
| ImageBiopsy Lab | KOALA | Radiography | Austria | 2019 | https://www.imagebiopsy.com/ | Knee OA labeling assistant |
| Imagen Technologies | Osteodetect | Radiography | USA | 2018 | https://imagen.ai/ai-software/ | Detect and localize distal radius fractures |
OA = osteoarthritis