Gleamer

The Gleamer Copilot suite is a set of detection models and nothing else. BoneView detects fractures, effusions, dislocations, and bone lesions on radiographs, and the portfolio extends to ChestView for chest X-ray and to bone age and musculoskeletal measurement. There is no hardware or services layer; where the software reaches a customer through an imaging platform partner, it is the algorithm being embedded, not a broader product.

Detection with the reader retaining the decision. BoneView presents suspected fractures inside bounding boxes with a three tier confidence label, positive with a solid box above 90 percent confidence, doubt with a dotted box between 50 and 90, and negative otherwise, plus optional worklist prioritization. The graded confidence output is more informative than a binary flag and helps a clinician calibrate trust, but the design keeps the human making the call. Assistive, clearly bounded.

The FDA 510(k) summary for BoneView describes a fully crossed multiple reader multiple case retrospective study with ground truth set by a panel of three US board certified radiologists across all indicated anatomical areas, tested across scanners from multiple manufacturers. That is a specific and inspectable validation design. Training set size and composition are not published in comparable detail, and there is no third party head to head benchmarking against competing fracture AI, so transparency is strong on the clearance study and lighter on the model internals.

One of the deeper evidence bases among musculoskeletal imaging vendors. The company reports roughly 30 peer reviewed publications, and specific results are documented: a US study through Boston University School of Medicine showing improved sensitivity and specificity with reduced reading time across the appendicular skeleton, rib cage, and thoracolumbar spine, and a 300 patient pediatric study reporting about 91 percent sensitivity that supported the pediatric clearance. Reported scale is large at 35 million exams across more than 2,000 institutions in 45 countries. The MRMC design underlying the clearance measures reader performance with and without the tool, which is the right question for a detection aid.

No specific PHI handling or data governance framework was located in the materials reviewed. Distribution through multiple imaging platform partners adds parties to the data path, making stewardship a per deployment question.

No HIPAA or BAA commitment was located in public materials. A French headquartered vendor selling into US radiology should be asked to establish business associate terms and confirm processing location, particularly where deployment runs through a third party platform.

No SOC 2, ISO 27001, or equivalent attestation and no trust center were located. The FDA submission references ISO 13485 quality system compliance, which governs medical device manufacturing rather than information security, so it does not substitute here.

BoneView is FDA 510(k) cleared as a computer assisted detection and diagnosis device, cleared K222176, and the company reports it is the only AI fracture detection software cleared for both adult and pediatric use, with a 2026 pediatric clearance for patients over two years of age. ChestView holds a separate FDA clearance. CE marked in Europe since 2020. Clear, current, multi product US authorization with a documented clearance basis.

The clearance study tests performance across multiple anatomical regions and multiple scanner manufacturers, which addresses one form of generalization, and the pediatric study extends validation to a distinct population. What is absent is a formal governance framework, ongoing monitoring commitment, or subgroup performance disclosure across demographics. Some evidence of generalization testing, no published governance program.

Distribution breadth substitutes for integration engineering. BoneView is available directly and through a wide set of imaging platform partners including Fujifilm, and other AI orchestration vendors indexed here, meaning a customer can often acquire it inside an imaging workflow already in place rather than as a standalone integration. This is a radiology and PACS environment fit; no EHR integration is claimed or applicable.

Multiple delivery paths exist, direct and through several imaging platform partners, which gives buyers routes to deployment but also means data residency and hosting terms vary by which path is chosen. Specific tenancy and residency terms are not published, and the partner distribution model makes them contract dependent.

No product pricing is published. The company discloses that the US contributes a substantial share of revenue and cites broad deployment scale, but nothing on per exam, per site, or licensing cost, and pricing likely differs between direct sale and partner embedded distribution, neither of which is disclosed.

Centered on musculoskeletal and trauma radiography, where BoneView covers the appendicular skeleton, rib cage, and thoracolumbar spine and is cleared for both adults and children, with the portfolio widening into chest X-ray and bone age. Read by radiologists, orthopedic surgeons, emergency physicians, and others across emergency and outpatient settings. Focused on plain film rather than spanning CT, MRI, and general radiology, which distinguishes it from broad multimodality platforms.