Diagnostic imaging

BoneView

Gleamer

Analyzes radiographs to highlight suspected fractures for professional review.

Designed for

Radiologist and clinician

Care setting

Hospital and imaging center

Specialty

Radiology, Emergency medicine, Orthopedics

Public evidence assessedReviewed August 31, 2026

Our assessment

Bottom line

BoneView has relatively strong evidence that AI assistance can improve reader fracture detection in a controlled setting. What remains less established is prospective clinical utility across local anatomy mixes, equipment, pediatric populations, and downstream management.

Based on public sources. RIR did not independently test this product. This is not an endorsement or recommendation.

What the evidence supports

Reviewed regulatory sources establish a cleared adjunctive radiograph analysis product for suspected fractures.

What remains uncertain

Performance across body regions, age groups, acquisition settings, and current software revisions requires deployment-specific review.

How it was studied

An FDA 510(k) summary describes a fully crossed retrospective multiple-reader, multiple-case study. Twenty-four readers interpreted 480 independent cases with and without BoneView, using a three-radiologist reference standard and sensitivity and specificity as primary measures.

Product facts

Intended use: Assist detection and localization of suspected fractures on eligible radiographs within the cleared scope.
Represented version: BoneView 1.1-US represented by FDA 510(k) K222176
Regulatory context: BoneView 1.1-US is FDA-cleared under K222176. Other versions and jurisdictions may have different labeling.

Sources reviewed

3 public sources represented in this evidence profile.

FDA 510(k) summary with BoneView reader studyRegulatory Gleamer regulatory product informationOfficial documentation FDA 510(k) K222176Regulatory

For clinical and investment reviewEvidence context and questions for deeper review

Evidence source base

Regulatory evidence with developer-sponsored clinical testing. Independent local reader evaluation remains valuable.

Important limitation

A controlled reader study does not establish current-version performance in pediatric care, unusual anatomy, local equipment, emergency workflow, or the downstream consequences of false findings.

Questions to ask

01Which body regions and patient ages are within scope?
02How are subtle and multiple fractures handled?
03What is performance on local imaging equipment?

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