ABMD Software
HeartLung CorporationABMD Software is an AI-powered application that measures bone mineral density from existing CT scans by analyzing the trabecular region of vertebral bones. It assists clinicians by providing retrospective assessment of bone density without the need for additional dedicated scans, thereby avoiding extra radiation exposure. It supports healthcare providers by offering BMD, Z-scores, and T-scores for evaluation, serving as a supplementary diagnostic tool rather than replacing standard DXA scans.
Intended Use
Post-processing AI-powered software intended to measure bone mineral density (BMD) from existing CT scans by averaging Hounsfield units in the trabecular region of vertebral bones. Not intended to replace DXA or other dedicated BMD tests, designed for opportunistic assessment on CT scans done for other reasons.
Technology
The software reads CT scans in DICOM format, extracts patient metadata, uses an AI trained model to segment vertebral bone trabecular regions, measures average Hounsfield units, calculates BMD, Z-score and T-score, and outputs segmentation and measurement results for review. The user cannot adjust segmentation but can accept or reject measurements.
Performance
The software underwent software verification and validation testing confirming functional requirements and performance specifications. It showed strong correlation with manual quantitative CT-based BMD measurements (r=0.97) and good correlation with DXA BMD measurements (r=0.72). No clinical or animal testing was required. Results demonstrate safety and effectiveness comparable to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/1/2021
8 months - 2
FDA Approval
7/29/2022
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- AutoChamber2024 • 510K
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